The present application provides a process for the preparation of Dexpramipexole, its pharmaceutically acceptable salts and its hydrates.

The present invention relate to pharmaceutical formulations comprising combination of delayed release form of pantoprazole or a pharmaceutically acceptable salt thereof  and sustained release form of domperidone together with one or more pharmaceutically acceptable excipients. Further the present invention relate to p...

The present invention provides a rapid method to assess the re-usability/lifetime of a chromatographic resin/matrix during preparative scale chromatography. The method specifically measures the difference in the column back pressures obtained at two different flow rates, during the cleaning step of a chromatographic p...

Processes for preparing substantially pure docetaxel, new crystalline forms of docetaxel and processes for preparation thereof, processes for preparing docetaxel trihydrate, and pharmaceutical compositions comprising docetaxel.

The present application relates to relates to processes for preparation of Apixaban and intermediates thereof.

The present application relates to solid state forms of Betrixaban and its Maleate salt, and processes for preparation thereof.

ABSTRACT Aspects of the present application relate to crystalline form of Entinostat, process for its preparation and pharmaceutical compositions thereof.

Preparation and isolation of amino vinyl cyclopropane carboxylic acid derivatives and salts thereof  methods of resolving enantiomers  and methods of identifying compositions and/or enzymes that are capable of resolving racemic or partially enantiomerically enriched mixtures.

The invention describes a stable therapeutically effective aqueous formulation of an anti B cell therapeutic antibody. This aqueous formulation can be lyophilized, and further reconstituted into a stable therapeutically active/effective aqueous form, which can be used for treating individuals needing the same. ...

Aspects of the present application relate to solid forms of Selinexor processes for their preparation and pharmaceutical compositions thereof. Specific aspects relate to crystalline and amorphous forms of Selinexor.

The present application relates to process for the preparation of Retigabine crystalline modification A and modification C. The present application also relates to the mixture of crystalline modifications of Retigabine and pharmaceutical compositions thereof.

Aspects of the present application relates to co-crystal of carfilzomib with maleic acid, process for the preparation of co-crystal of carfilzomib with maleic acid, process for the preparation of pure carfilzomib from co-crystal of carfilzomib with maleic acid and process for the preparation of amorphous carfilzomib.

The invention describes a method of purification of antibodies from a sample comprising one or more impurities such as host cell contaminants and aggregates, using a filtration step. In particular, this invention employs the use of a depth filtration step prior to an ion-exchange chromatographic step.

Pharmaceutical formulations comprising amorphous pemetrexed or its salts, and processes to prepare the formulations.

The present invention relates to an in-vitro bioassay for distinguishing post translationally modified isoforms of a therapeutic protein. In particular the present invention relates to an in-vitro method for distinguishing post translationally modified isoforms of an antibody by C1q based ELISA involving use of a me...

An inhalation device for inhalation of a medicament from an openable capsule, the device comprising: a housing unit including a dispersing chamber; a mouthpiece removably attached to the housing unit and in communication with the dispersing chamber; a mesh provided between the dispersing chamber and the mouthpiece to...

Substantially non-porous polymeric microparticles comprising a hydrophobic polymer and a plasticizer, and containing therein a bioactive or bioinactive agent.

The present invention relates to a process for the preparation of letrozole and its purification.

The present invention provides a novel amorphous form ofRosiglitazone Maleate. The invention provides a process for preparation of the amorphous form ofRosiglitazone maleate that comprises the dissolution of Rosiglitazone Maleate in nitrile solvents such as acetonitrile, propionitrile and the like or in alcohol...

The present invention relates to an improved process for preparation of substantially pure Lurasidone hydrochloride from Lurasidone free base.

The present invention relates to an improved process for the preparation of antidiabetic compounds having the formula (1). where R represents (C1-C6) alkyl group such as methyl, ethyl, propyl, isopropyl, butyl and the like.

A PHARMACEUTICAL COMPOSITION COMPRISING: a) a core comprising premix of (-) eneantiomer of omeprazole b) one or more layers of subcoat and c) an enteric coating layer surrounding said subcoating layer

The present application relates to a process for the preparation of aliskiren and its pharmaceutically acceptable salts. In particular the present application relates to a process for the preparation of intermediates for aliskiren and their conversion to aliskiren or its salts.

There is provided an improved process for the preparation of substantially pure Trospium chloride and its pharmaceutical compositions.

The present invention provides crystalline form N of empagliflozin and pharmaceutical compositions comprising crystalline form N of empagliflozin and a process for preparation of empagliflozin having greater than 99.8% of chiral purity.

Processes for the preparation of palonosetron hydrochloride and its crystalline forms.

Acid addition salts of Nilotinib and process for the preparing the acid addition salts of Nilotinib. The acid is selected from Ethanedisulfonic acid, Isethionic acid and Napthalene-2-sulfonic acid.

The present invention relates to processes for the preparation of aprepitant crystalline Form I and Form II.

The present application relates to process for the preparation of Prasugrel and its pharmaceutically acceptable salts.

Polymorphic forms of saxagliptin hydrochloride and processes for their preparation

Aspects of the present invention relate to process for preparation of amorphous form of dapagliflozin, amorphous solid dispersion of dapagliflozin together with one or more pharmaceutically acceptable carriers, process for its preparation and pharmaceutical composition thereof.

Crystalline Forms zeta and eta of perindopril erbumine.

Accordingly, the present invention provides an improved process for the preparation of 1-(2-(dimethylamino)-1-(4-methoxyphenyl) ethyl) cyclohexanol hydrochloride (Venlafaxine hydrochloride) of formula (1), which comprises. a reduction of 1-(cyano-(p-methoxy phenyl)methyl)cyclohexanol of formula (2) using palladium ...

The present invention provides an improved process for the preparation of [R- (E)-I- [[[I-[3-[2-[7-chloro-2-quinolinyl] ethenyl] phenyl]-3-[2-(I-hydroxy-I-methylethyl) phenyl] propyl] thio] methyl] cyclopropaneacetic acid (Montelukast) of Formula (1) and its amine salts comprising of primary, secondary and tertiary ...

DIV ALPROEX PHARMACEUTICAL COMPOSITIONS The present invention relates to modified release pharmaceutical compositions of valproic acid compound coated particles, processes for preparation of the compositions and method of use, treatment and administration. Further the present invention relates to modified release pha...

A process for preparation of amorphous Elagolix sodium and solid dispersion thereof.

The present invention provides trifluoroacetyl copolymers useful as standard molecular weight markers in the intermediary stage for obtaining glatiramer acetate having desired average molecular weight. The present invention further provides a process for determining the average molecular weight of glatiramer acetate...

The invention relates to a cell culture process for decreasing the galactosylated content and/or increasing the G0F content of a glycoprotein. The process involves subjecting recombinant cells expressing the said glycoprotein to a temperature and pH shift and supplementing cell culture with glutamine. ...

The present application relates to a process for the preparation of proton pump inhibitors of the benzimidazole-type represented by the general Formula I, Formula I wherein R1 and R2 are the same as or different from each other and are selected from hydrogen, methoxy or difluoromethoxy, R3, R4 and R5 are the same as...

The present application relates to compositions for parenteral administration of epothilone or epothilone analogs.

This invention describes a cell culture process for the production of glycoproteins in mammalian cell system, characterized by temperature and pH shift. In particular, the cells are cultured at specific temperature and pH for a particular period of time, after which, temperature and pH are shifted to obtain a glycopro...

Pharmaceutical controlled-release formulations comprising lamotrigine or its pharmaceutically acceptable salts, coated with a modified-release coating with or without a water-soluble pore-former.

The application describes efficient methods of purifying a modified cytokine. The processes include the use of a chromatographic technique for the purification of the desired cytokine. The purified cytokine can be used to prepare therapeutic compositions.

The present invention relates to novel heterocyclic compounds of the general formula (I), their derivatives, their analogs, their tautomeric forms, their stereoisomers, their regioisomers, their polymorphs, their pharmaceutically acceptable salts, their pharmaceutically acceptable solvates and pharmaceutically accepta...

The present invention directed towards an alternative, simple, economic and industrially feasible process for the preparation of crystalline Form-I of Repaglinide of Formula-I, which is simple, non-hazardous and commercially viable process. The process comprises the dissolution of the crude Repaglinide in a solvent ch...

An improved process for the preparation of optically pure benzyl-2-azabicyclo[3.3.0]octane-3-carboxylate hydrochloride which is a key intermediate for preparation of Ramipril . The process for the preparation of optically pure benzyl-2-azabicyclo[3.3.0]octane-3-carboxylate hydrochloride comprises reacting racemic b...

The present application relates to crystalline forms of suvorexant p-toluene sulfonate and suvorexant benzene sulfonate. The present application further relates to a process for the preparation of crystalline forms of suvorexant p-toluene sulfonate and suvorexant benzene sulfonate.

Abstract The invention of the present application relates to crystalline forms of Ribociclib succinate or solvate thereof, and process for preparation of the same.

Aspects of the present invention relates to an isolated intermediate of Dapagliflozin (Formula III) and its preparation, process for the preparation of Dapagliflozin, process for the preparation of crystalline propane-1,2,3-triol solvate of Dapagliflozin, solid premix of dapagliflozin with the polymer selected from ...

Aspects of the present application relate to amorphous Lumacaftor, its amorphous solid dispersion and pharmaceutical compositions thereof. Aspects of the present application further relate to processes for the preparation of amorphous form and amorphous solid dispersion of Lumacaftor.

The present application relates to the amorphous form of Daclatasvir dihydrochloride and the processes for the preparation thereof. The application further provides its solid dispersion having Daclatasvir dihydrochloride in amorphous form and process for its preparation.

The present invention is related to a method for extensive characterization of glycan isoforms of erythropoiesis stimulating agents by mixed mode chromatography using salt gradient, wherein the said chromatographic technique is coupled with mass spectrometry. Mixed mode chromatography used herein is a 5 combination ...

The present application provides novel crystalline forms of idelalisib, processes for preparing them, and pharmaceutical compositions containing them. The present application also encompasses the use of novel crystalline forms of idelalisib provided herein, for the preparation of other solid state forms of idelalisi...

This present invention relates to a method of stabilizing an aqueous pharmaceutical preparation susceptible to degradation by formulating in a dual buffer system wherein the individual buffers are selected from phosphate, aspartate, glutamate, and succinate buffer.

The main aspect of the present application relates to (2’R)-2’-Deoxy-2’-Fluoro-2’-C-Methyl-D-Ribofuranose compounds. Another aspect of the application provides processes for the preparation of (2’R)-2’-Deoxy-2’-Fluoro-2’-C-Methyl-D-Ribofuranose compounds, their salts, stereo isomers, polymorphs and solvates thereof ...

Aspects of the present invention relate to process for preparation of amorphous form of Sofosbuvir, amorphous solid dispersion of Sofosbuvir together with one or more pharmaceutically acceptable carriers, process for its preparation and pharmaceutical composition thereof.

The present invention provides an improved process for the preparation of Nilotinib

The present invention provides process for the preparation of crystalline Form R6 of Nilotinib hydrochloride by drying crystalline Form R5 using microwave heating.

The present application relates to amorphous solid dispersion of cobicistat with a polymer selected form a group of HPC, methacrylic acid, methyl cellulose and ethyl cellulose and process for the preparation thereof. Moreover, the present application relates to a pharmaceutical composition comprising amorphous solid d...

ABSTRACT A dual compartment container for retaining separate ingredients of an pharmaceutical dosage form and facilitating their mixture just before use, said dual compartment container comprising: (a) a first compartment comprising a continuous side wall, a closed bottom, and a top portion, wherein said top portio...

Abstract The present application relate to processes for the crystalline forms of Lumacaftor. Specific aspects relate to processes for the preparation of crystalline form SV1 and SV2 of Lumacaftor.

The invention relates to a stable, preservative free, aqueous shampoo compositions of terbinafine hydrochloride and zinc pyrithione, the compositions comprising one or more solubilizers, one or more surfactants and one or more foaming agents, one or more thickening agents. Methods of preparing such compositions are ...

The invention describes a cell culture process comprising modulating the concentration of amino acids in a cell culture media to control the acidic variants or galactosylated glycans in an antibody composition.

A solid dosage form dispensing container comprising: (a) a unit compartment comprising a closed bottom portion, an open top portion, and a side wall portion; (b) a removable inner cap mounted on top of the unit compartment, wherein said inner cap comprises an open bottom portion, a side wall portion, and a top portio...

Process for the preparation of vemurafenib and its intermediates

ABSTRACT The present application relate to an improved process for preparation of Ivacaftor.

Abstract Present invention relates to pharmaceutical formulations comprising amorphous canagliflozin and one or more pharmaceutically acceptable excipients; and process for preparing such pharmaceutical formulations.

Abstract The present invention provides the process for the preparation of Roxadustat and its intermediates.

The present invention provides a delayed release pharmaceutical formulation comprising omeprazole or its pharmaceutically acceptable salts in multi-particulate form and an inactive particulate processes for their preparation.

Abstract The present specification provides process for the preparation of amorphous Dasatinib.

The present application relates to improved processes for preparation of N-methylhex-5-en-1-amine and its salts.

The present application relates to a process for the preparation of Regorafenib and its desfluoro analogue (Sorafenib) and novel intermedites thereof.

Aspects of the present invention provide stable liquid ready to use injectable formulation of bortezomib or pharmaceutically acceptable salts thereof. Another aspect of the present invention provides processes for preparation of such stable liquid ready to use injectable formulation of bortezomib and methods of usin...

Process for preparation of Amorphous Dasatinib using Dasatinib HCl.

The present application covers a process for the preparation of lorcaserin free base and its pharmaceutically acceptable salts.

The present application relates to amine salt of obeticholic acid. Specifically, the present application relates to (S)-a-methylbenzylamine and diethylamine salt of obeticholic acid. The present application also relates to a process for preparation of amorphous form of obeticholic acid comprising converting amine salt...

The present invention relates to amorphous lorcaserin hydrochloride; amorphous solid dispersion comprising lorcaserin hydrochloride and one or more pharmaceutically acceptable carries; processes for preparation thereof; pharmaceutical compositions comprising amorphous lorcaserin hydrochloride and one or more pharmaceu...

A novel processes for the preparation of suvorexant (formula I) its related compounds and its intermediates that are simple economical and commercially viable. (I)

The present invention relates to stable liquid pharmaceutical formulations of cyclophosphamide. The invention further relates to stable liquid formulations of cyclophosphamide prepared by a process comprising a step of reducing the moisture content from cyclophosphamide or liquid compositions of cyclophosphamide or ...

The present application relates to a method of treating migraine or cluster headache in a human patient said method comprising administering subcutaneously composition comprising sumatriptan or its pharmaceutically acceptable salt in an amount equivalent to 3 mg sumatriptan base.

The present application provides improved processes for crystallization of Rasagiline hemitartrate having improved filterability.

The invention is a method of forming a composition having an enantiomeric excess of trans-4-amino-cyclopent-2-ene-1carboxylic acid derivatives which includes preferentially precipitating the less desired enantiomers by addition of amine the isolating trans compound from the remaining liquor.

The invention discloses a cell culture process to increase the percentage of high mannose glycans in a glycoform composition. In particular, the cells are cultured at first temperature for about 20 hours and subsequently subjected to reduced temperature to obtain a glycoprotein with glycoform composition containing an...

The invention describes a cell culture process for reducing percentage of high mannosylated and afucosylated glycans. In particular, the process consists of supplementing cell culture with Manganese that is distributed over the course of cell culture.

The present application relates to a chemo-enzymatic process for the preparation of pure trans-1, 4-cyclohexanedicarboxylic acid monoester of formula (A) or formula (1) using hydrolase enzyme.

Process for the preparation of Abiraterone acetate using potassium trifluoroborates

Aspects of the present invention relate to pharmaceutical compositions comprising at least one acid labile pharmaceutically active substance, or any salts, polymorphs, hydrates, esters, isomers, derivatives, or mixtures thereof, for oral use, processes for the manufacture of such compositions and methods of preventi...

Processes for preparing olmesartan medoxomil. In embodiments  processes for preparing olmesartan medoxomil do not require isolating one or more intermediate compounds.

The present application provides processes for the preparation of olanzapine pamoate, amorphous form of olanzapine pamoate and processes for its preparation. Also provides processes for the purification of pamoic acid.

The present application relates to a series of substituted pyra zolopyridin 6 amines having the general formula (I) including their stereoisomers and/or their pharmaceutically acceptable salts. Wherein R R R R R R and n are as defined herein. The present invention further relates to pharmaceutical compositions compr...

The invention describes chromatographic methods for purification of protein of therapeutic or commercial importance. In particular the invention describes methods for isolation and purification of protein expressed by recombinant DNA methods. The proteins may be expressed in various expression systems such as, E.col...

The invention describes a cell culture process comprising feeding nutrients to the culture medium and thereafter harvesting at particular by-product concentration of the fed nutrients to obtain desired qualitative and quantitative attributes in therapeutic antibody composition.

The present application relates to a process for the preparation of hemicalcium salt of sacubitril. Specifically the present application relates to triethylamine salt of sacubitril and its use for the preparation of a supra-molecular complex of sacubitril and valsartan.

The present invention relates to an extended release pharmaceutical formulation comprising Ondansetron and pharmaceutically acceptable salts thereof and at least one release rate controlling polymer and one or more other pharmaceutically acceptable excipients.

The present invention provides pharmaceutically acceptable stable compositions containing high amount of dimethyl fumarate (DMF). The compositions of the present invention contain minimum amount of excipients and can be prepared by conventional manufacturing methods.

The present invention relates to a series of substituted compounds having the general formula (I) including their stereoisomers and/or their pharmaceutically acceptable salts. (I) Wherein A m Rls R2 R3 R4 are as defined herein. This invention also relates to methods of making these compounds including intermediates....

The present application relates to a process for the preparation of desired particle size of Aprepitant by sonocrystallization.

The present invention describes a frozen therapeutic protein preparation  in particular an antibody preparation resistant to freeze/thaw associated dimerization and particulate formation  and a method of preparing the same.

A process for preparing Nilotinib hydrochloride Form R5 and Form R6 comprises: step a) providing a solution of Nilotinib free base in acetic acid and optionally an organic solvent step b) adding hydrochloric acid taken in an organic solvent to the solution of step a) then separating Nilotinib hydrochloride Form R5 (st...

The present invention relates to methods and means for determining the relative binding activity of a therapeutic antibody based on the affinity of said antibody for a specific binding partner thereof. In particular, this invention relates to methods and means for use in FcRn binding assays wherein the competitive bin...

The invention describes a method of production of glycoprotein with a specific glycoform composition. The desired glycoform profile is brought about by altering the culture conditions on the basis of IVCC rather than the age of the culture. Further, the method renders a high product yield.

The invention describes a method of production of glycoprotein composition with an increased percentage of Man5 and/or afucosylated glycans. Further  the process describes the use of Manganese for increasing the percentage of Man5 and afucosylated glycans.

The invention describes a method of production of glycoprotein with a particular glycoform composition. The glycoform composition is obtained by simultaneous reduction of temperature and pH. Further, the method maintains the cell growth rate and renders high product yield.

The application relates to processes for preparing fipamezole and its pharmaceutically acceptable salts  and intermediates thereof. It also provides intermediate compounds of Formula III and Formula IV  and processes for their preparation.

The present invention relates to a stable pharmaceutical formulation comprising dabigatran etexilate or its pharmaceutically acceptable salts, and processes of preparation thereof. The formulations of the present invention may contain pharmaceutically acceptable acids.

The present application relates to crystalline form of a supra-molecular complex of valsartan and sacubitril which is known as LCZ-696 and process for preparation thereof.

An improved process for the preparation of Ibrutinib.

Aspect of the present application relates to process for the preparation of clopidogrel bisulfate and its intermediates.

An improved process for the preparation of Ibrutinib.

Aspects of the present application relate to complex of Lumacaftor and Ivacaftor, and pharmaceutical compositions thereof. Aspects of the present application specifically relate to crystalline complex and amorphous phase of Lumacaftor and Ivacaftor and their preparative processes.

The present invention provides process for the preparation of Lenvatinib and its intermediates.

Processes for the preparation of ranolazine and intermediates thereof, and pharmaceutical compositions comprising razolazine

The present application provides a process for the preparation of Dabigatran etexilate, including pharmaceutically acceptable salts or tautomers thereof. The present application also provides novel intermediate compounds that are useful in the preparation of Dabigatran etexilate and its salts or tautomers. ...

The application relates to processes for preparing valganciclovir and pharmaceutically acceptable salts thereof, as well as intermediates for the processes, valganciclovir hydrochloride is represented by Formula II. FIG.

The main aspect of the present application relates to stereoselective preparation of sofosbuvir, its salts, stereo isomers, polymorphs and solvates thereof.

The invention provides a pharmaceutical composition for intranasal administration comprising a salt of sumatriptan or a physiologically acceptable solvate thereof, an alkyl glycoside or saccharide alkyl ester and optionally at least one pharmaceutically acceptable excipient, wherein the said composition provides Tma...

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The present application provides novel solid state forms of Afatinib di-maleate, processes for preparing them, and pharmaceutical compositions containing them.

The present invention discloses an optimized SPR method for measuring binding affinity between Fc of an antibody and Fc gamma receptors, wherein the method employs protein L to capture immunoglobulin and is devoid of cross reactivity. Further, the said method measures kinetic constants such as association constant (Ka...

The present invention relates to use of fixed dose combination comprising Ketorolac or its pharmaceutically acceptable salts thereof and Difluprednate for the treatment of post operative ocular inflammation. The present invention further relates to a pharmaceutical composition comprising fixed dose combination comp...

The present invention relates to non-enteric pharmaceutical compositions comprising a benzimidazole proton pump inhibitor such as omeprazole or its pharmaceutically acceptable salts, polymorphs, isomers, enantiomers, prodrugs or derivatives thereof, process of preparation of such compositions and method of using the...

Aspects of the present application relate to pharmaceutical formulations comprising atorvastatin or pharmaceutically acceptable salts thereof and glimepiride as active agents wherein both atorvastatin or pharmaceutically acceptable salts thereof and glimepiride are in immediate release form.

The present application relate to amorphous form and amorphous solid dispersion form of olaparib and process for preparation thereof.

The present application relates to pemetrexed disodium  substantially free from specific process-related impurities  and processes for the preparation thereof.

Aspects of the present application relate to improved processes for preparation of Selinexor and intermediates thereof.

The present invention discloses a method for purifying anti-idiotypic antibodies using a series of purification via chromatographic columns, wherein the columns comprise targeted antibody coupled affigel hydrazide column; human IgG coupled affigel hydrazide column; and human IgG coupled NHS activated sepharose. Furt...

The present invention relates to a multiparticulate, controlled release oral solid formulations of levodopa comprising: i) an extended-release component comprising levodopa, carbidopa and a rate-controlling excipient; and ii) an extended-release component comprising a carboxylic acid, levodopa, carbidopa and a r...

The present application provides processes for preparation of Idelalisib and intermediates thereof. The present application also provides a process for purification of Idelalisib.

A topical pharmaceutical composition comprising betamethasone dipropionate, calcipotriene monohydrate and one or more pharmaceutically acceptable excipients.

Abstract The present invention relates to process for preparation of 1-(3-Ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethylamine of the formula (II), its resolution and its use in preparation of Apremilast of formula (I).

The present application relates to a series of substituted pyrazolo[l 5 a]pyridine compounds their use as tropomyosin receptor kinase (Trk) family protein kinase inhibitors method of making and pharmaceutical compositions comprising such compounds.

The present application relates to processes for preparation of Apixaban and intermediates thereof.

The present application provides a process for the preparation of Bortezomib, its intermediates and process for crystalline forms of Bortezomib.

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The present invention provides an improved process for the preparation of eliglustat to salts thereof. Present invention also provides a crystalline eliglustat free base form R1.

The present invention provides solid state forms of empagliflozin, complexes of empagliflozin with amino acids, processes for their preparation and their use in purification of empagliflozin and also provided pharmaceutical compositions comprising them and their use in therapy.

The present invention provides amorphous eluxadoline, its solid dispersion comprising one or more pharmaceutically acceptable carriers and the processes for their preparations.

The present invention provides pharmaceutical compositions of two or more active agents, comprising combination of at least one angiotensin inhibitor, at least one calcium channel blocker, and at least one diuretic, in a single dosage form.

The present application relates to a process for preparation of tert-butyl (R)-(1-([1,1'-biphenyl]-4-yl)-3-hydroxypropan-2-yl)carbamate (IA). The compound of formula (IA) may be used as an intermediate for the preparation of sacubitril.

Abstract The present application relates to a process for preparation of ceritinib and intermediates thereof. Specifically, the present application relates to a process for preparation of N-(4-(1-benzyl-1,2,3,6-tetrahydropyridin-4-yl)-2-isopropoxy-5-methylphenyl)acetamide(VC) comprising treating N-(4-(bromomethyl)-2-i...

The present application relates to improved processes for the preparation of Liraglutide.

The present application relates to new salts of Rociletinib, polymorphic forms of the salts and compositions thereof.

The present application relate to processes for preparing ticagrelor and to intermediates that are useful in the processes.

The present specification relates to process for the preparation of Ingenol mebutate from Ingenol and intermediates thereof. The present specification further relates to process for crystalline and amorphous Ingenol mebutate.

The present application relates to the solid state forms of Eliglustat hemitartrate and the processes for the preparation thereof. The application further provides solid dispersion of Eliglustat hemitartrate having Eliglustat hemitartrate in amorphous form.

The present application relates to processes for the preparation of Mirabegron, crystalline and amorphous forms thereof.

The present application relate to a process for preparation of 4-Methylene tetrahydrofuran compound of formula II, which is useful as an intermediate for the preparation of halichondrin B analogues such as Eribulin.

Methods for the preparation of ziprasidone hydrochloride monohydrate having definite particle size distribution parameters, from anhydrous ziprasidone hydrochloride

Abstract The present invention is related to a rapid UPLC based analytical method for separating and characterizing glycan species obtained from antibody sample. The method comprises a gradient program wherein a salt gradient is obtained by mixing acetonitrile and 100mM ammonium formate in varying compositions. The s...

The invention of the present application relates to the process for the preparation of intermediates of obeticholic acid and their conversion to obeticholic acid. The process involves the conversion of compound of formula (VI) to compound of formula (VII) in presence of an organic base.

Stable pharmaceutical formulations for the oral administration of lacidipine compositions which provide improved dissolution rate and stability on storage are disclosed. Process for preparing lacidipine compositions by hot melt extrusion of the drug along with a polymer, a solubilizer and optionally one or pharmaceuti...

The present application relates to processes for the preparation of retigabine and Its pharmaceuticaiiy acceptable salts.

The present invention provides amorphous form of lesinurad, amorphous solid dispersion of lesinurad and processes for preparation thereof. The present invention also provides a pharmaceutical composition comprising amorphous or amorphous solid dispersion of lesinurad and one or more pharmaceutically acceptable exc...

The present invention relates to a conditioning shampoo composition comprising one or more conditioning agents, one or more thickeners, one or more foaming agents, one or more foam boosters, one or more humectants and one or more pearlizing agent, wherein the composition is sulphate and paraben free. Methods of prepar...

The invention provides a pharmaceutical composition for intranasal administration comprising a salt of sumatriptan or a physiologically acceptable solvate thereof, an alkyl glycoside or saccharide alkyl ester and optionally at least one pharmaceutically acceptable excipient, wherein the said composition provides Tmax ...

The present invention provides pharmaceutically acceptable compositions comprising discrete particles of fumaric acid derivative and pharmaceutically acceptable excipient/s. The compositions of the present invention may be enteric coated.

The invention relates to a cell culture process for decreasing the galactosylated content and/or increasing the G0F content of a glycoprotein. The process involves subjecting recombinant cells expressing the said glycoprotein to a temperature and 5 pH shift and supplementing cell culture with arginine. ...

Pharmaceutical compositions comprising bortezomib for oral or parenteral administration. Specific aspects relate to stable, sugar free pharmaceutical compositions of bortezomib, including its pharmaceutically acceptable salts or solvates, in the form of ready-to-use solutions, lyophilized forms, or physical admixtures...

The present invention relates to lyophilized compositions comprising daptomycin or pharmaceutically acceptable salts or solvates thereof with improved reconstitution time for parenteral administration and the processes for preparation thereof.

The present application relates to three crystalline forms of a complex between sacubitril, valsartan, sodium and saccharin and process for preparation thereof. The present application also relates to use of a complex between sacubitril, valsartan, sodium and saccharin for pharmaceutical composition. ...

The present invention provides process for the preparation of Elagolix sodium and its intermediates thereof.

The present application relates to intermediates of Suvorexant and synthetic processes for their preparation.

The present invention is related to a method for cryopreservation of high cell density PBMC by employing composition of cryoprotectants such as a polyol and polysaccharide. The said composition results in source effector cells that retain their functional activity during cryopreservation and revival. The said cells ar...

Pharmaceutical tablets comprising a first layer formulated for immediate release of telmisartan from a dissolving matrix and a second layer formulated for immediate release of hydrochlorothiazide from a dissolving matrix, methods for producing tablets and methods of use for treating hypertension.

Controlled release pharmaceutical compositions comprising trospium or pharmaceutically acceptable salts thereof and one or more release controlling components, wherein the composition is in monolithic form, reservoir form, multiparticulate form, or a combination thereof.

The present invention relates to process for preparation of ruxolitinib intermediates and their use in preparation of Ruxolitinib of formula (I) and its pharmaceutically acceptable salts.

The present invention relates to stable pharmaceutical formulations comprising irbesartan Form A alone or in combination with hydrochlorithiaze and at least one 2-vinyl pyrrolidone containing polymeric compound. The processes of preparation of the pharmaceutical formulations and use of such formulations are also provi...

Aspects of the present application relate to solid forms of Lumacaftor and processes thereof. Specific aspects of the present application relate to crystalline form SV1, SV2, SV3, SV4 and processes for their preparation thereof.

A process for the preparation of enantiomerically pure (R)-3-(4-phenoxyphenyl)-1-(piperidin-3-yl)-1H-pyrazolo[3,4-d]pyrimidin-4-amine from the diastereomeric salt.

Abstract The present application relates to a process for the preparation of desired particle size of Rivaroxaban by sonocrystallization.

Aspects of the present application relate to crystalline forms of agomelatine, an amorphous solid dispersion of agomelatine, and processes for their preparation. In aspects, the application relates to the preparation of crystalline Form I of agomelatine. Further aspects relate to pharmaceutical compositions comprising...

The present application related to amorphous form of Brigatinib, solid dispersion of Brigatinib, a process for their preparation and pharmaceutical compositions thereof.

The present invention relates to an oral pharmaceutical composition comprising metronidazole wherein metronidazole is released from the composition generally at the pH 5.0 and above.

Aspects of the present application relate to pharmaceutical formulations comprising a nonsteroidal anti-inflammatory drug, together with a proton pump inhibitor drug, to reduce the incidence of gastrointestinal complications associated with chronic therapy with a nonsteroidal anti-inflammatory drug. Aspects of the pre...

ABSTRACT: One aspect of the present invention relates to process for preparation of (R)-2-cyclopentyl-2-hydroxyacetate of the formula (II) by stereo selective enzymatic reduction. Another aspect of the present invention provides an enzyme catalyzed resolution of 2-cyclopentyl-2-hydroxyacetate of the formula (IIa). Ano...

The invention describes a cell culture process for modulating percentage of high mannosylated and afucosylated glycans wherein the cell culture process comprises culturing cells in a culture medium and supplementing cell culture with manganese.

An anti-wrinkle under eye composition comprising peptides, a flavonoid, a chelating agent, a skin lightening agent, an exfoliating agent, a skin protectant and one or more dermatologically acceptable excipients.

The present invention relates to the process for the preparation of (S)-1-(3-Ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethylamine of the formula (II) and its use in preparation of Apremilast. The present invention also relates to a crystalline form of (S)-1-(3-Ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethylamine of ...

The present application relates to processes for preparation of Selexipag, its amorphous form, amorphous solid dispersion and pharmaceutical composition thereof.

Aspect of the present invention relates to an improved process for the preparation of crystalline Form 1 of clopidogrel bisulphate.

The present invention relates to docetaxel and processes for preparing docetaxel, including process-related intermediates. The present invention also relates to processes for preparing substantially pure docetaxel and intermediates.

Aspects of the present application relate to crystalline forms of fidaxomicin and processes for their preparation. In aspects, the application relates to the preparation of crystalline Forms and amorphous fidaxomicin. Further aspects relate to pharmaceutical compositions comprising these polymorphic forms of fidaxom...

The invention relates to pharmaceutical formulation comprising dipyridamole in extended release composition and aspirin in immediate release composition.

There is provided salts and polymorphs of sitagliptin, processes for the preparation thereof, and pharmaceutical compositions comprising the same.

Methods for purifying modified cytokines. A process includes the use of a cation exchange chromatographic technique for the purification of a desired cytokine. The purified cytokines can be used in therapeutic compositions.

ABSTRACT The present application relates to amorphous solid dispersion of LCZ-696 with one or more pharmaceutically acceptable carrier. Specifically, the present application relates to amorphous solid dispersion of LCZ-696 with one or more pharmaceutically acceptable carrier selected from a group of hydroxypropyl meth...

The present invention relates to devices for inhaling powdered medicaments and methods of using such devices for pulmonary administration of drugs. More particularly, the present invention relates to devices for dispersing dry powder medicaments and administering them by inhalation to a person in need of pulmonary dru...

The application relates to processes for preparation of linagliptin and its intermediate 3-methyl-8-bromo-xanthine. The structures of linagliptin (I) and 3-methyl-8-bromo-xanthine (VI) are shown below.

The invention describes a method of purification of a fusion protein of therapeutic or commercial importance. In particular, the invention describes a method for purification of TNFR:Fc fusion proteins comprising a hydrophobic interaction chromatography.

The invention describes a feeding strategy for a cell culture process for increasing titer/vv of the therapeutic antibodies without impacting product’s qualitative characteristics

The present application relates to an acylation process for the preparation of Liraglutide.

The present invention provides crystalline forms of Ibrutinib and processes for their preparation.

Process for the purification of Cabazitaxel.

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Present invention relates to stable pharmaceutical formulation comprising phenylephrine or salt thereof, chlorpheniramine maleate and one or more pharmaceutically acceptable excipients; and process for preparing such stable pharmaceutical formulation.

The present application relate to an improved process for preparation of Ivacaftor, crystalline Ivacaftor form I and process for its preparation

ABSTRACT Aspects of the present application relates to crystalline forms of ledipasvir, process for the preparation thereof and pharmaceutical formulations of crystalline forms of ledipasvir.

The present application provides a process for the preparation ribociclib or its acid addition salts, using compound of formula (III) as a key intermediate. The application also provides amorphous and amorphous solid dispersion of ribociclib succinate and process for preparation thereof.

A pharmaceutical formulation providing more than one release of a benzimidazole drug. In embodiments drug containing particles are coated with at least one polymer having solubility at pH values about 5 to about 7.5 and other drug containing particles are coated with at least one polymer having solubility at pH values...

Topical pharmaceutical compositions comprising shea butter, aloe butter, mango butter, cocoa butter, and one or more pharmaceutically acceptable excipients. Further, topical compositions comprising squalene, aloe vera, vitamin E acetate, and one or more pharmaceutically acceptable excipients is disclosed. These compos...

Process for the preparation of Ibrutinib and its intermediates

The invention relates to a fixed dose pharmaceutical formulation comprising analgesic agent and anti-spasmodic agent and one or more pharmaceutically acceptable excipients wherein the pharmaceutical formulation is used for relief of menstrual and abdominal cramps associated with dysmenorrhea. ...

Aspects of the present invention relates to (S)-1,3-dimethyl-4-piperidone and its process, process for the preparation of (3S,4R)-1,3-dimethyl-4-[3-(1-methylethoxy)-phenyl]-4-piperidinyl carbonic acid ethyl ester using (S)-1,3-dimethyl-4-piperidone, process for the preparation of (3R,4R)-3-(3,4-dimethyl-4-piperidinyl)...

The present invention relates to a process for the preparation of lesinurad or its pharmaceutically acceptable salts thereof. The present invention further provides novel intermediates, process for their preparation and their use for the preparation of lesinurad or its pharmaceutically acceptable salts thereof. ...

The present invention relates to solid forms of Lesinurad, their processes and pharmaceutical compositions thereof.

The present application relate to processes for the preparation of bendamustine and its pharmaceutically acceptable salts.

The invention relates to stable rapid drying non aqueous topical compositions of mometasone furoate in the form of spray the composition comprising one or more solubilizers one or more non aqueous volatile solvents and film formers or emollients. Methods of preparing such compositions are also provided. The present in...

This invention is related to a method for detecting anti drug antibody in a sample by employing an assay format wherein, concentration of coating agent is optimized to achieve better sensitivity. Further, the method can detect any Ig isotype as it is only dependent on antigen specificity of ADA, as shown in this inve...

The application relates to process for preparation of hexahydropyrano [3, 2-b] pyran compound of formula II, which is useful as an intermediate for the preparation of halichondrin B analogues such as Eribulin.

ABSTRACT The invention describes a method of reducing endotoxins from a therapeutic product composition comprising an absolute filtration step prior to every downstream unit operation to reduce the endotoxin levels below threshold levels.

The present application provides process for preparation of 4-Methylene tetrahydrofuran compound of formula II, which is useful as an intermediate for the preparation of halichondrin B analogues such as Eribulin.

Amorphous varenicline tartrate, amorphous solid dispersions of varenicline tartrate and a pharmaceutical carrier, and processes for the preparation thereof

Aspects of the present application relate to crystalline form, cocrystal of sofosbuvir and processes for their preparation. Further aspects relate to pharmaceutical compositions comprising the crystalline polymorphic form and cocrystal of sofosbuvir.

The present invention includes processes for the preparation of crystalline esomeprazole magnesium dehydrate and/or trihydrate. The present invention includes esomeprazole magnesium dihydrate Form B having a degree of crystallinity of about 70% or less. The present invention includes micronized esomeprazole magnesium ...

The present invention relates to a stable oral liquid pharmaceutical composition of celecoxib or its pharmaceutically acceptable salts thereof. The celecoxib present in the compositions as described herein do not show any precipitation when subjected in Fasted State Simulated Gastric Fluid (FaSSGF) at pH 2.0 temperatu...

Abstract The present application relates to an improved process for the preparation of Eliglustat or its pharmaceutically acceptable salts thereof. Further relates to isolation of intermediates in the form of solid and their use for preparation of Eliglustat or its pharmaceutically acceptable salts thereof. ...

The present invention relates to a process for the preparation of Lesinurad intermediate and their use in preparation of Lesinurad or its pharmaceutically acceptable salts thereof.

The present application relates to crystalline form of Asenapine free base and a process for the preparation of crystalline form of Asenapine free base.

The present invention provides amorphous empagliflozin, amorphous solid dispersion of empagliflozin, and pharmaceutical compositions comprising them and their use in therapy.

The present application provides taste masked film-coated ranitidine tablets comprising ranitidine or its pharmaceutically acceptable salts together with one or more pharmaceutically acceptable excipients, processes for its preparation and providing relief from heartburn associated with acid indigestion and sour stoma...

The present application relates to process for the preparation of Tofacitinib (or) salt thereof and process for the preparation of crystalline form of Tofacitinib citrate.

Aspects of the present invention relate to for preparation of amino sulfone intermediate of Apremilast involving the use of an enzymatic process. Another aspect of the present application provides the use of amino sulfone intermediate prepared according to present invention for the preparation of Apremilast. ...

The present application relates to a process for the preparation of substantially pure canagliflozin. The present application further relates to a process for the preparation substantially pure compound 18a’.

Aspects of the present application relate to formulations comprising desvenlafaxine, and processes for preparing the formulations. In particular aspects, the present application relates to stabilized formulations comprising desvenlafaxine succinate, and processes for preparing the same. Aspects of the application furt...

The present application relates to a series of substituted imidazo[l 2 a]pyridine compounds of formula (I) pharmaceutically acceptable salts pharmaceutically acceptable solvates or stereoisomers thereof their use as tropomyosin receptor kinase (Trk) family protein kinase inhibitors method of making and pharmaceutical ...

The application relates to improved processes for preparing valganciclovir hydrochloride

The present invention relate to a process for preparing paliperidone palmitate, a process for purifying paliperidone palmitate and a process for purifying palmitic acid thereof.

The present application provides novel solid state forms of Afatinib di-maleate, processes for preparing them, and pharmaceutical compositions containing them.

Processes for the preparation of dexlansoprazole, an amorphous form of dexlansoprazole, a solid dispersion of amorphous dexlansoprazole and a pharmaceutically acceptable carrier, and processes for their preparation. Also provided are crystalline compounds 2-[(R)-[(4-chloro-3-methyl-2-pyridinyl) methyl] sulfinyl]-1H-...

The present application relates to crystalline forms of imatinib mesylate designated as form-R, form-S, and processes for their preparation. Further aspects relate to the use of these crystalline forms in the preparation of pharmaceutical compositions.

The present invention is drawn to novel compositions of topiramate and phentermine for the treatment of obesity and related conditions, including conditions associated with and/or caused by obesity. The present invention features compositions of topiramate and phentermine, wherein the compositions are devoid of microc...

Aspects of the present application relate to solid forms of Venetoclax and its salts. Specifically, the present application relates to various crystalline forms of Venetoclax, its salts and their preparative processes.

The present invention provides a process for the preparation of crystalline form of Dasatinib monohydrate using mixture of solvents methanol and water.

Process for preparation of tadalafil  and its derivatives along with their isomers using new amide intermediates.

The application relates to process for preparing active pharmaceutical ingredients, its intermediates, salts and esters thereof by employing the continuous flow micro mixing reactor technology.

The invention relates to novel child-resistant blister card packages for medicaments. The blister card package comprises a rigid container sheet with cavities for containing a medicament and a cover sheet sealed to the container sheet and covering the cavities. The blister card package is detachable into individual se...

The present application related to a process for the preparation of crystalline Ivacaftor Form B.

The invention provides a method of purification of an anti-VEGF antibody using chromatographic technique. The method involves the use of cation-exchange chromatography for the purification of the antibody wherein the cation exchange eluate is collected as a whole without the need for fractionation. The purified antibo...

The present application relates to amorphous form of palbociclib and process for preparation thereof. The present application also relates to amorphous solid dispersion of palbociclib with a pharmaceutically acceptable excipient wherein the pharmaceutically acceptable excipient may be selected from a group of hydroxyp...

The present invention provides a process for the preparation of Lesinurad intermediates and their use in preparation of Lesinurad or its pharmaceutically acceptable salts thereof.

The present application relate to process for preparation of tetrahydrofuran compound of formula II, 4-Methylene tetrahydrofuran compound of formula V and tetrahydropyran compound of formula IX which are useful as intermediates for the preparation of halichondrin B analogues such as Eribulin or its pharmaceutically ac...

The present application relates to the process for the preparation of SGLT2 inhibitors, further covers a process for the preparation of Canagliflozin, preparation of amorphous form of Canagliflozin and solid dispersion of Canagliflozin

The present application relates to processes for preparation of Dimethyl fumarate or crystalline form thereof. The present application also relates to uniform dimethyl fumarate particles and process thereof.

Abstract The present application relates to a process for preparation of acalabrutinib or a pharmaceutically acceptable salt thereof. The present application also further relates an amorphous solid dispersion of acalabrutinib with one or more pharmaceutically acceptable carrier along with its process for preparatio...

The present application provide processes for the preparation of fingolimod and its pharmaceutically acceptable salts process for the purification of fingolimod hydrochloride and process for the preparation of amorphous fingolimod hydrochloride.

The invention describes a method of separation of antibody charge variants using an ion- exchange chromatography technique operated in displacement chromatography mode. The separated charge variants may be used for therapeutic and/ or analytical purposes.

ABSTRACT The present application relate to process for preparation of hexahydropyrano [3, 2-b] pyran compound of formula IIIa, which is useful as an intermediate for the preparation of halichondrin B analogues such as Eribulin or its pharmaceutically acceptable salts.

The application relates to processes for preparing polypeptides. Also provided are processes for preparing glatiramer acetate.

Process for the preparation of substantially pure Ibrutinib.

The present invention relates to improved processes for preparation of pyrimidine derivatives.

Aspects of the present application relate to crystalline form, amorphous form of prasugrel hydrobromide, processes for the preparation of crystalline forms and amorphous form of prasugrel hydrobromide and their use in pharmaceutical compositions.

The present application relate to salts of Lumacaftor. Specific aspects of the present application relate to salts of Lumacaftor and processes thereof.

Salts of O-desmethylvenlafaxine, their polymorphic forms, and processes for their preparation.

Pharmaceutical formulations comprising raloxifene or its salts, esters, polymorphs, isomers, hydrates, solvates, or derivatives thereof having defined particle sizes. Also described are processes for preparing formulations and methods of using such formulations.

Stable premixes comprising retigabine, or pharmaceutically acceptable salts thereof, and at least one pharmaceutically acceptable carrier, and process for preparing the same are disclosed. Stable premixes comprising retigabine, or pharmaceutically acceptable salts thereof, and at least one pharmaceutically acceptable ...

The present invention relates to the processes for preparing non-needle shaped crystalline alpha-form of Imatinib mesylate.

Aspects of the present application relate to processes for the preparation of agomelatine and its intermediates which are used in manufacturing process of agomelatine.

Aspects of the present application relate to a crystalline form of Mirabegron monohydrochloride and a crystalline form of Mirabegron, and process for their preparation and use thereof in the pharmaceutical composition.

The present application relates to a stable topical composition comprising benzoyl peroxide in combination with one or more silicone compounds and a zinc compound. The present application further relates to the use of the topical composition as well as to a process for making such topical composition ...

The present application relates to pure amorphous form of ceritinib and process for preparation thereof. Another aspect of the present application relates to amorphous solid dispersion of ceritinib and process for preparation thereof.

Processes for the preparation of substantially pure lenalidomide. The application also relates to an enriched, substantially pure, and pure amorphous form of lenalidomide and solid dispersions containing amorphous lenalidomide.

Aspects of the present invention relate to amorphous form of mirabegron amorphous solid dispersion of mirabegron process for its preparation processes for preparation of a form crystal and ß form crystal of mirabegron and pharmaceutical composition thereof.

The present invention related to a method for estimation of reversible aggregate content in protein sample, wherein the said method estimates total aggregate content present in a neat protein sample and amount of irreversible aggregate content present in a processed sample. The method according to the invention 5 wher...

The present invention is directed to processes for preparation of iron sucrose complex and purification of the obtained iron sucrose through diafiltration.

The present application relates to processes for the preparation of amorphous Raltegravir potassium and Raltegravir potassium Form-3.

The present application relate to novel crystalline form of pitavastatin calcium and processes for its preparation and isolation.

The present invention relates to a rapid and efficient method for separation of a non-ionic detergent from a protein preparation containing the said detergent  wherein the method does not involve any phase separation  protein precipitation or chromatographic steps.

The invention relates to a solid oral dosage form comprising a pharmaceutical^ active ingredient in combination with an enhancer which may further enhance the bioavailability and/or the absorption of the active ingredient. Accordingly, a solid oral dosage form comprises a drug and an enhancer wherein the enhancer is s...

The invention provides a method of purification of antibodies using chromatographic technique. The method involves the use of anion exchange chromatography for the purification of the antibody. The purified antibody can be used as a therapeutic composition.

The present application provides an improved process for the preparation of Dexpramipexole, its pharmaceutically acceptable salts and its hydrates with highest chiral purity.

The present application relates to processes for the preparation and purification of decitabine  and to processes for the preparation of a crystalline form of decitabine.

A process for preparing a 3-aryloxy-3-arylpropylamine, comprising reacting a 3-hydroxy-3-arylpropylamine with a halogen-substituted aryl compound, in a solvent comprising N-N-dimethyl acetamide or hexamethyl phosphorous

NOT AVAILABLE

Aspect of the présent application relate to process for the recovery of camphorsulfonic acid used in the resolution of racemic dopidogrel and re use of the recovered camphorsulfonic acid for resolution and an improved process for the racemization of R-isomer (or) enriched R-isomer of clopidogrel.

Methods of producing the compounds of formula (22) and (23) or enantiomers thereof comprising hydroformylation of compounds of the formula (21) or their enantiomers: using Kelliphite as chiral ligand wherein R is -H or an amine-protecting group.

The present disclosure provides processes for the preparation of the compound (4R-cis)-1,1-dimethylethyl-6-[2[2-(4-fluorophenyl]-5-(1-methylethyl)-3- phenyl-4[(phenyl amino)carbonyl]-1H-pyrrole-1-yl]ethyl]-2,2-dimethyl-1,3- dioxane-4-acetate of Formula II by the Paal-Knorr condensation of 1,4-diketone of Formula III ...

A process comprising: (a) reduction of N-acetyl-3-aminopyridine (2): or its salt in the presence of hydrogen and a palladium catalyst deposited on solid support; (b) converting racemic N-acetyl-3-aminopiperidine (3) or its salt produced in step (a) to rac-3-aminopiperidine (rac-4) or its salt; (c) resolution of the ...

Preparation Of Montelukast A process for preparing amorphous montelukast sodium comprises removing solvent from a solution comprising montelukast sodium using agitated thin film drying.

The present invention relates to improved processes for the preparation of valacyclovir hydrochloride and intermediates thereof.

Amorphous Aprepitant Coprecipitates A co precipitate comprising amorphous aprepitant and a pharmaceutically acceptable carrier is prepared by rapidly removing solvent from a solution containing aprepitant and the carrier.

NA

Processes for preparing a non-hygroscopic and stable crystalline alpha-form of imatinib mesylate

The present application relates to cocrystal of agomelatine with phosphoric acid and its method of preparation. Another aspect of the application relates to process for the preparation of crystalline Form I of agomelatine.

The invention discloses an improved process for the preparation of rosiglitazone free base form II by adjusting pH of a mixture comprising rosiglitazone salt and a solvent to a pH of 7-10, recovering the rosiglitazone freebase and recrystallized the rosiglitazone free base from an alcohol.

The present invention related to an improved process for the preparation of cyclopentyl derivatives which are useful intermediates in the preparation of pharmaceutical^ active agents.

Modified release pharmaceutical formulations comprising niacin in a non-swellable core, and processes for preparation of the formulations.

Processes for the preparation of montelukast and its salts.

A pharmaceutical dosage form for treating or preventing cardiovascular events comprises therapeutic amounts of: a β-adrenergic receptor antagonist, a diuretic, or both; a cholesterol-lowering agent; an inhibitor of the renin-angiotensin system; and aspirin.

This application relates to atorvastatin intermediates and processes for the preparation of atorvastatin intermediates including (R)-tert-butyl 6-cyano-5-hydroxy-3-oxohexanoate using the reagent hexamethyldisilazane lithium salt (HMDS-Li)

Pre-mix compositions containing conjugated estrogens and a pharmaceutical carrier, and pharmaceutical formulations containing a pre-mix composition. Further the invention relates to processes for preparing the premix compositions and pharmaceutical formulations containing a pre-mix composition.

The present invention relates to pharmaceutical formulations of atorvastatin or its pharmaceutically acceptable salts, solvates, hydrates, enantiomers, polymorphs or their mixtures; and processes for preparing the same, and their methods of use, treatment and administration. Further, the present invention relates to...

A process for preparing rivastigmine or a salt there of comprising reacting S-(-)-[1-(3-hydroxyphenyl)ethyl]dimethylamine with N-ethyl-N-methyl carbamoyl chloride in presence of an organic base.

NA

This invention provides novel crystalline forms of N-(trans-4-isopropylcyclohexyl carbonyl) D-phenylalanine and process for the preparation of N-(trans-4-isopropylcyclohexyl carbonyl) D-phenylalanine which may be produced by crystallization of N-(trans-4-isopropylcyclohexyl carbonyl) D-phenylalanine with solvents and ...

Controlled-release pharmaceutical formulations comprising pseudoephedrine or any of its pharmaceutically acceptable salts, processes for preparing the pharmaceutical formulations, and methods of using the formulations.

NOT AVAILABLE

NOT SCANNED

A process for preparing terbinafine or a salt thereof having high purity.

The present invention relates to stable pharmaceutical compositions of desloratadine comprising desloratadine in combination with a desloratadine-stabilizing amount of at least one amino acid.

The present invention relates to a process for the preparation of aprepitant and its intermediates. The present invention also relates to a potential process related impurity 3-[1-(3,5-bisfluoromethylphenyl) morpholin-2-one of Formula Hc where R is hydrogen (hereinafter referred to as "spiro derivative of aprepitant...

Pharmaceutical formulations comprising levetiracetam and having an inner solid phase and outer continuous phase, wherein one or both of the phases comprise at least one hydrophobic or lipophilic material, or combinations thereof.

Polymorphic forms of tadalafil, and processes for their preparation.

The present invention relates to pharmaceutical compositions comprising eszopiclone, including its pharmaceutically acceptable salts, hydrates, clathrates, solvates, polymorphs, and mixtures thereof. The invention also relates to processes for preparing the compositions and their methods of use. ...

The present invention relates to a novel process for the preparation of optically pure isomers of 2-(4-Hydroxy phenoxy)-2-methyl-butyric acid methyl ester of the formula (I) and formula (II).

Rizatriptan is prepared by reacting 4-hydrazinophenylmethyl-1,2,4-triazole dihydrochloride with 4-N,N-dimethylaminobutanal dimethylacetal in the presence of hydrochloric acid.

A process for preparing (4S,5R)-5-carboxymethyl-2,2-dimethyl-4-phenyl-oxazolidine-3-carboxylic acid t-butyl ester, an intermediate in the preparation of anticancer compounds having a taxane skeleton, such as paclitaxel, docetaxol, etc.

There is provided a process for the preparation of montelukast of the Formula (I) Formula (I)

NOT AVAILABLE

Aspects of the present invention relate to pharmaceutical formulations comprising naproxen and esomeprazole for therapeutic purposes, and methods of preparing the same. Further aspects of the present invention relate to fixed dose pharmaceutical formulations comprising naproxen, or pharmaceutically acceptable salts th...

ABSTRACT The present application relates to processes for the preparation of amorphous valganciclovir hydrochloride, comprising combining a solution of valganciclovir with an anti-solvent.

A process for preparing tadalafil, comprising reacting a compound having a formula: wherein R is hydrogen, a C1 to C6 straight chain branched or cyclic alkyl group, a C1 to C6 straight chain branched or cyclic alkoxy group, or an aryloxy group, and X is an inorganic or organic acid, with a compound having a formu...

The present invention relates to a process for the preparation of amlodipine and its salts, and intermediates thereof. In particular it relates to process for the preparation of the compound phthalimido amlodipine, which is useful as an intermediate for the preparation of amlodipine and its salts.

*** Evaporates during processing. Manufacturing process: 1. Dissolve prasugrel hydrochloride, stearic acid and hydroxypropyl methylcellulose in methanol.

A process for preparing atorvastatin calcium Form I comprising adding a solution comprising atorvastatin calcium and an alcohol to water

The present invention relates to powder compositions comprising aprepitant with improved solubility properties.

The present invention relates to a process for the preparation of nimesulide which involves a reduced number of stages, resulting in high yields of the desired product and is suitable for industrial scale production.

The present invention provides 5 (s)-(2'-hydroxyethoxy)-20(s)-campthothecin substantially free from 5 (R)-(2'-hydroxyethoxy)-20(s)-campthothecin, as well as methods for its preparation and use.

Voriconazole is prepared by a process comprising condensing 1-(2,4-difluorophenyl)-2-(1H-1,2,4-triazole-1-yl) ethanone with 4-chloro-6-ethyl-5-fluoropyrimidine, in a ketone, ether, aliphatic hydrocarbon, or aromatic hydrocarbon solvent, to give (2R,3S/2S,3R)-3-(4-chloro-5-fluoropyrimidin-6-yl)-2-(2,4-diflurophenyl)-1-...

A process for preparing (1R)-1-[3,5-bis (trifluoromethyl) phenyl] ethanol comprising reacting (±)-1-[3,5-bis (trifluoromethyl) phenyl] ethanol with an acetylating agent in the presence of an enzyme to form (1R)-1-[3,5-bis (trifluoro-methyl) phenyl] ethyl acetate and hydrolyzing (1R)-1~[3,5-bis (trifluoromethyl) phen...

The present invention relates to crystalline Form II of vardenafil, a process for its preparation, and pharmaceutical compositions containing it.

Stable pharmaceutical compositions comprise zafirlukast and pharmaceutically acceptable salts, solvates, polymorphs, enantiomers or mixtures thereof, together with one or more pharmaceutically acceptable polymers, and processes for their preparation. An aspect of the invention relates to solubility enhanced form of ...

The present invention relates to crystalline polymorphic forms of alfuzosin hydrochloride designated as Form II, Form III, Form IV and amorphous form, which are characterized by their X-ray powder diffraction (XRPD) patterns and pharmaceutical compositions comprising the same.

The present invention relates to a process for the preparation of eszopiclone and intermediates thereof. In one aspect, the present invention relates to a process for the preparation of eszopiclone compound of Formula I, which process comprises: a) reacting zopiclone with an enantiomerically pure di-p-toluoyl tart...

The present invention relates to pharmaceutical formulations comprising azacitidine or its pharmaceutically acceptable salts. Further, the invention relates to processes for preparing the stable formulations comprising azacitidine or salts thereof, and methods of using the formulations for treating various types of ...

A process for preparing valsartan.

The present invention relates to a process for the preparation of 2-(dimethylaminomethyl)-4-thiazolemethanol, an intermediate used in the synthesis of nizatadine, which process comprises of reacting dimethylamino thioacetamide hydrochloride with 1,3-dichloroacetone in presence of halogenated solvent and alkali metal...

A process for preparing Zolpidem, comprising reacting 3-(N,N-dimethylaminomethyl)-6-methyl-2-(4-methylphenyl)-imidazo-[1,2-a]-pyridine with an alkyl halide and, without isolating any intermediate, reacting with an alkali metal cyanide, then reacting with a base to form 6-methyl-2-(4-methylphenyl)-imidazo-[1,2-a]-pyr...

The present invention relates to a process for preparation of rosiglitazone and its pharmaceutically acceptable salts.In particular, the present invention relates to rosiglitazone and its pharmaceutically acceptables salts free of at least one of the dehydro and the succinic acid impurities of rosiglitazone and proc...

The present invention provides for an orally administrable capsule comprising at least two mini-tablets, or at least two mini-capsules, or a combination of at least a mini-tablet and a mini-capsule, wherein one of said mini-tablet or mini-capsule comprises a nonsteroidal anti-inflammatory drug and the other mini-table...

A process for preparing alfuzosin or a salt thereof, which minimizes the 1, 2 concentration of an N -(4-amino-6,7-dimethoxyquinazolin-2-yl)-N1-methyl-N -(4-amino-6,7-dimethoxyquinazolin-2-yl)-propane-1,3-diamine impurity in the product.

A complex formed from cetirizine or a salt thereof, and an ion exchange resin. A pharmaceuitical excipient.

A process for the separation of a thiazolidine compound from its related impurities which comprises: a) Bringing a solution or suspension comprising a thiazolidinedione compound and its related impurities into contact with a hydrophobic natural or synthetic polymer based resin; b) Washing the adsorbent resin with a ...

The invention provides a process processes for the preparation of pure granisetron and its pharmaceutically acceptable salts, substantially free of process related impurities. This invention also further provides a process for the preparation of 1-methyl-indazole-3carboxylic acid and endo-3-methyl-azabicyclo [3.3.1]...

The present invention provides a method for efficient extraction of nucleic acids from cell free sample(s). The method can yield nucleic acids for various applications, for e.g. quantification of host cell nucleic acid contamination.

A solid pharmaceutical dosage form comprises a core particle containing at least one pharmaceutical active ingredient and/or excipient that is sensitive to acid, a subcoating containing a chemically reactive component disposed over the core, and an enteric coating over the subcoating.

A process for preparing tolterodine with high purity.

ABSTRACT Pharmaceutical compositions comprising particles of metaxalone or its derivatives, wherein from about 10-100%, by weight, of the metaxalone particles have particle sizes greater than about 250 μm. Processes for preparing the pharmaceutical compositions, are also disclosed.

A solid pharmaceutical dosage form comprises a granulated powder mixture comprising atorvastatin or a salt thereof and a granulated powder mixture comprising nicotinic acid or a derivative thereof.. The present invention further encompasses stabilized pharmaceutical compositions of atorvastatin or its salts and nico...

The present invention provides a method of increasing the levels of low pI isoforms of expressing erythropoiesis stimulating protein in a medium containing metal ions to improve product quality.

A process for preparing crystalline Form B of ibandronate sodium, comprising: a) providing an aqueous solution of ibandronate sodium; b) optionally distilling the solution of step a) to concentrate the reaction mass and diluting with water; c) crystallizing the ibandronate sodium by combining the solution with an ...

The present inverition relates to pharmaceutical compositions comprising montelukast or its pharmaceutically acceptable salts, solvates, polymorphs, enantiomers or mixtures thereof. The invention also relates to processes for preparing the compositions and their methods of use. Further invention relates to stable phar...

The present invention relates to a process for the preparation of valacyclovir and salts thereof with reduced levels of impurities and metal cotents.

There is provided polymorphs and amorphous form of pemetrexed or its pharmaceutical acceptable salts and process for making thereof.

The present invention relates to stable compositions comprising zoledronic acid, wherein zoledronic acid is complexed with a cyclodextrin, such as hydroxypropyl β cyclodextrin. The invention further relates to processes for making the compositions.

The present invention relates to a process for the preparation of aprepitant.

A pharmaceutical dosage unit comprising a support particle having an Imorphous substituted benzimidazole drug composition coated thereon, wherein the Irug composition is substantially free from alkaline substances and surfactants.

There is a provided process for the preparation of substantially pure lopinavir and amorphous form of lopinavir.

Abstract The present invention relates to pharmaceutical fixed dose compositions, processes for preparing the same and methods of use and treatment of hypertension and other cardiovascular disorders. The present invention further relates to pharmaceutical fixed dose compositions of metoprolol or its salts, with ram...

The present invention provides for stable pharmaceutical compositions comprising therapeutic amounts of a cholesterol-lowering agent, an inhibitor of the renin-angiotensin system, a diuretic, aspirin and optionally at least one beta-adrenergic receptor blocking agent.

The present invention relates to pharmaceutical compositions comprising palonosetron and its pharmaceutically acceptable salts, in the form of a ready-to- use solution or a lyophilized form. Specific embodiments of the invention relate to stable pharmaceutical formulations of palonosetron and its pharmaceutically ac...

In an aspect, the invention provides simple, industrially scalable and cost-effective processes for the preparation of telmisartan which has purity acceptable for its use in the preparation of pharmaceutical compositions.

Stabilized pharmaceutical compositions contain ramipril, in combination with indapamide. An embodiment provides a capsule containing an immediate-release composition comprising ramipril, and a controlled-release composition comprising indapamide.

The present invention relates to novel intermediates of linezolid, process for their preparation and their use in the preparation of linezolid or its pharmaceutical accepatable salts, bydreates and solvates.

The present invention relates topharmaceutical compositions comprising substituted benzimidazoles or their pharmaceutically acceptable salts, solvates,single isomers, enationers or mixtures therof.More particularly, present invention relates to pharmaceutical composition in the form of a capsule comprising substitut...