The present invention provides process for preparation of highly pure Fingolimod hydrochloride (I) having purity of greater than 99.8% (by HPLC), (I) without involving the use of column chromatographic purification in the entire process. Fingolimod hydrochloride (I) obtained by the process of present invention ma...

The present invention relates to an environment friendly and direct one pot process for preparing highly pure Monomethyl Fumarate (I) without involving any isolation of any intermediates. The improved process of present invention is industrially upscalable and provides highly pure 4-methoxy-4-oxobut-2-enoic acid...

The present invention provides to an improved process for the preparation of highly pure Erlotinib hydrochloride of formula (I) The substantially pure Erlotinib hydrochloride (I) obtained by improved process of the present invention is having purity of greater than 99.8% (by HPLC). Erlotinib hydrochloride is use...

The invention relates to pharmaceutical composition comprising 86.0-96.0 % w/w of Imatinib mesylate, 0.05-0.2% w/w of binder and 1-6% w/w of disintegrant, wherein the composition is prepared using binder in isopropyl alcohol solvent. Said pharmaceutical compositions comprising Imatinib mesylate provides improved sta...

The invention relates to stable oral pharmaceutical composition comprising 3-8% w/v of magnesium hydroxide, 15-40% v/v of liquid paraffin and 0.01-1.0% w/v of sodium picosulfate, 01-05% w/v of colloidal anhydrous silica as stabilizing agent and 1-4% w/v of non-ionic surfactant, wherein the composition is prepared us...

The present invention provides a commercially viable process for preparation of highly pure Temozolomide (VI), which is useful in the treatment of cancer. The invention also provides an economically viable process for an intermediate compound of formula III useful in the process for preparing Temozolomide. ...

A pharmaceutical composition of Otilonium bromide comprising of an immediate release layer and sustained release layer which may be used for the treatment of irritable bowel syndrome or spasmodic pain of the gut.

The invention provides a prolonged release pharmaceutical composition of Indapamide comprising 0.1-2%) w/w of Indapamide, 10-25%) w/w of one or more cellulose derivatives polymers with the viscosity of 20-80 cP measured using 0.5% w/w of aqueous solution. The prolonged release pharmaceutical composition of Indap...

A commercially viable process for the preparation of 2-amino cyanoacetamide of formula (I) (I) which is a useful pharmaceutical intermediate for preparing Temozolomide API useful in the treatment of cancer. The process according to the present invention results in highly pure material, which is desirable to pr...

The present invention relates to a process for the preparation of the active pharmaceutical ingredient Fingolimod Hydrochloride (I) and its highly pure intermediate [2-acetamido-2-(acetyloxy methyl)-4-phenylbutyl] acetate(II) (I) (II)

The present invention relates to a process for preparation of crystalline Ambroxol Hydrochloride (I) (I) The present invention further relates to a process for preparation of Crystalline Form-SAH of Ambroxol Hydrochloride.

NITROSAMINE IMPURITIES ABSTRACT The present invention relates to a new, robust, economical and industrially viable Reverse Phase-High performance liquid chromatography (RP-HPLC) method for the determination and quantification of genotoxic nitrosamine impurities in drug substance or drug products or their combinati...

ABSTRACT: The present invention relates to a process for preparation of stable crystalline Form (designated as –SBU) of Busulfan (I) Novel crystalline Form-SBU of Busulfan is characterized by X-ray powder diffraction pattern comprising 2?° peaks selected from the XRPD peak set of 12.48, 14.18, 15.24, 16.21, 18....

The present invention relates to a film coating tablet comprising Olaparib or a pharmaceutically acceptable salt thereof, wherein the film coating tablet is obtained by Rapid mixture granulator. The present invention further relates to a process for manufacturing a film coating tablet of the invention as well as ...

The present invention provides to an improved process for the preparation of thermodynamically stable crystalline Lenvatinib mesylate of formula (I). The present invention also provides novel crystalline Lenvatinib mesylate (I) designated as form SL obtained by the improved process of present invention is h...

The present invention provides to an improved process for the preparation of highly pure crystalline Pazopanib Hydrochloride of formula (I). (I) The crystalline Pazopanib Hydrochloride (I) obtained by improved process of the present invention is having purity of greater than 99.9% (Area % by HPLC). Pazopani...

The invention relates to a pharmaceutical composition of crystalline Form B of Palbociclib having particle size less than 30µm (D90) comprising a process of wet granulation, wherein the composition optionally consisting organic acid and exhibiting in vitro drug release of more than 90% of active released within 30...

ABSTRACT Process for the Preparation of Palbociclib The present invention provides to an improved process for the preparation of highly pure crystalline Palbociclib of formula (I) The crystalline Palbociclib (I) obtained by improved process of the present invention is having purity of greater than 99.8% (% w/w by...

The invention relates to a unique and stable pharmaceutical composition derived from wet granulation process wherein said composition exhibiting cumulative in vitro release profile ranging from >60% of Erlotinib HCl is released within 10 minutes, >70% of Erlotinib HCl is released within 15 minutes and >85% of Erl...

ORAL DISPERSIBLE FILM OF NIFEDIPINE The present invention discloses composition of an oral dispersible film of Nifedipine comprising film forming agent, plasticizer, saliva stimulating agent, sweetener, solvent and a flavouring agent. The invention further discloses process of preparing of oral dispersible fi...

The present invention discloses the novel orodispersible film composition of Carbamazepine comprising film forming agent, plasticizer, saliva stimulating agent, sweetening agent, solvent and a flavouring agent. The invention further discloses process of preparing of orodispersible film of Carbamazepine. The ...

The present invention provides a commercially viable one pot process for the preparation of pure Methyl 2-(2-methylphenoxymethyl) phenylglyoxylate of formula (I). which is useful intermediate for preparing Kresoxim-methyl. The present invention also provides a process for the purification of Methyl 2-(2-methylp...