Hyderabad, India
Hyderabad, India

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Patent
Hetero Drugs Ltd | Date: 2017-04-12

The present invention is directed to a method for the purification of a protein, preferably a recombinant protein selected from the group consisting of erythropoietin, darbepoetin alfa, a functional fragment or a functional derivative of erythropoietin or darbepoetin alfa. Also, the present invention reads on a protein produced by said method and a corresponding pharmaceutical composition comprising said protein.


Patent
Hetero Drugs Ltd. | Date: 2016-02-17

The present invention provides sequential chromatography steps and conditions for purification of a recombinant protein, especially recombinant darbepoetin alfa.


The present invention relates to certain novel salts of Betulinic acid derivatives, to process for preparing such compounds, to use the compounds in treating diseases or disorders mediated by HIV infection, to methods for their therapeutic use and to pharmaceutical compositions containing them.


Process for the preparation of erlotinib hydrochloride crystalline polymorph form A substantially free of polymorph form B, erlotinib hydrochloride crystalline polymorph form A and a pharmaceutical composition comprising erlotinib hydrochloride crystalline polymorph form A.


The present invention provides a novel and stable hydrated form of erlotinib free base, and a process for its preparation thereof. The present invention also provides a process for preparation of erlotinib hydrochloride crystalline polymorph a substantially free of polymorph B. The present invention further relates to erlotinib hydrochloride crystalline particles having mean particle size (D_(50)) ranging from about 4 m to 15 m and 90 volume-% of the particles (D_(90)) ranging from about 14 m to 30 m, to the methods for the manufacture of said crystalline particles, and to pharmaceutical compositions comprising said crystalline particles.


Patent
HETERO DRUGS Ltd | Date: 2011-12-20

The present invention relates to a high assayed esomeprazole magnesium dihydrate substantially free of its trihydrate form. The present invention further provides an improved and commercially viable process for preparation of high assayed esomeprazole magnesium dihydrate substantially free of its trihydrate form. The present invention also provides an improved process for preparation of pure amorphous esomeprazole magnesium. The present invention further provides an improved and commercially viable process for preparation of substantially enantiomerically pure esomeprazole in neutral form or as a pharmaceutically acceptable salt or as its solvates including hydrates. The present invention also provides solid form of esomeprazole calcium salt, its polymorphs (form 1, form 2 and amorphous form) and processes for their preparation thereof.


Patent
Hetero Drugs Ltd | Date: 2011-03-16

Crystalline solid of eprosartan acetate and a process for the preparation thereof which comprises dissolving crude eprosartan free base in acetic acid, adding methylene chloride at a temperature below about 40 C and collecting the precipitated eprosartan acetate crystalline solid.


Patent
HETERO DRUGS Ltd | Date: 2013-04-29

The present invention relates to a process for obtaining pure aprepitant substantially free of undesired diastereomeric isomer, namely 5-[2(S)-[1(RS)-[3,5-bis(trifluoromethyl)-phenypethoxy]-3-(S)-(4-fluorophenyl)-morpholin-4-yl-methyl]-3,4-dihydro-2H-1,2,4-triazol-3-one. The present invention further provides an improved process for preparation of aprepitant crystalline form II. The present invention also relates to novel amorphous form of aprepitant, a process for its preparation and to a pharmaceutical composition comprising it. The present invention further relates to aprepitant having a mean particle size of less than about 11.5 microns, a process for its preparation and to a pharmaceutical composition comprising it. Thus, for example, aprepitant having a content of diastereomeric impurity of 1.1% is dissolved in ethyl acetate at 70 C., the solution is concentrated to half the initial volume by distilling off ethyl acetate, and the resulting solid is collected at 0-5 C. to give pure aprepitant substantially free of its diastereomeric impurity.


Patent
Hetero Drugs Ltd | Date: 2011-03-16

Substantially pure eprosartan free base and a process for the preparation thereof, which comprises suspending eprosartan acetate in water, adjusting the pH of the suspension to about 6.7 to 7.5 with a base, and collecting the precipitated substantially pure eprosartan base.


Patent
HETERO DRUGS Ltd | Date: 2012-07-03

The present invention relates to novel amorphous and crystalline forms of efavirenz, processes for their preparation and pharmaceutical compositions containing them. In accordance with the present invention efavirenz crude is dissolved in acetone at 25 C.-30 C., the solution is slowly added to water for 30 minutes at 0 C.-5 C., stirred for 1 hour at the same temperature, the separated solid is filtered, washed with water and dried at 55 C.-60 C. for 5 hours to give amorphous efavirenz.

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