Hetero Drugs Limited

Hetero Research Foundation

Rapolu Raji Reddy

Bandi Parthasaradhi Reddy

Kura Rathnakar Reddy

Dasari Muralidhara Reddy

Kesireddy Subash Chander Reddy

Bandi Vamsi Krishna

Thungathurthy Srinivasa Rao

Nagabelli Murali

Thungathurthy Srinivas Rao

Dandamudi Satish Kumar

Voggu Ramesh Reddy

Adulla Venkat Narsimha Reddy

Jambula Mukunda Reddy

Matta Ramakrishna Reddy

Ayyalasomayajula Satya Srinivas

Medabalimi Peter Paul Raj

Puchakayala Srinivasa Reddy

Itiyala Srinivas Reddy

Attunuri Narasa Reddy

Bandi Vamsi Krishan

Ayyalsomayajula Satya Srinivas

Described herein is pure amorphous darunavir, methods of making pure amorphous darunavir and pharmaceutical compositions containing amorphous darunavir and a pharmaceutically acceptable excipient.

Amorphous darunavir

The present invention provides novel solvated forms of darunavir and processes for their preparation. The present invention also provides novel processes for the preparation of darunavir amorphous form and pharmaceutical compositions comprising it. Thus, for example, darunavir 2-methyl-2-butanol solvate was dissolved in methylene dichloride, distilled under vacuum at 45&#xb0; C. to obtain a residue, cyclohexane was added to the residue and stirred for 30 hours at 20 to 25&#xb0; C., and the separated solid was filtered, washed with cyclohexane and dried under vacuum at 50&#xb0; C. for 12 hours to yield darunavir amorphous form.

Polymorphs of darunavir

The present invention provides novel crystalline hydrochloride salt of darunavir, process for its preparation and to pharmaceutical composition comprising it. The present invention also provides novel process for preparation of darunavir amorphous form and pharmaceutical composition comprising it.

Crystalline hydrochloride salt of darunavir

The present invention relates to process for the resolution of omeprazole. The present invention further provides a novel compound of enantiomers of omeprazole cyclic amine salt and a process for preparing it. The present invention also provides a solid of (R)- or (S)-omeprazole cyclic amine salt and a process for preparing it. The present invention also provides a process for the preparation of esomeprazole magnesium dehydrate substantially free of its trihydrate form. The present invention also provides a process for the preparation of recovery of chiral BINOL.

Process for the resolution of omeprazole

The present invention provides novel salts of raltegravir, processes for their preparation and pharmaceutical compositions comprising them. The present invention also provides crystalline sodium salt of raltegravir, process for its preparation and pharmaceutical compositions comprising it. The present invention further provides a process for the preparation of amorphous sodium salt of raltegravir. The present invention further provides a process for the preparation of raltegravir potassium crystalline form H1.

Salts of raltegravir

3-[3-(Trifluoromethyl)phenyl]propionaldehyde is a key intermediate for the preparation of cinacalcet hydrochloride. The present invention provides a novel process for the preparation of 3-[3-(trifluoromethyl)phenyl]propionaldehyde. The present invention also provides an improved process for preparation of cinacalcet hydrochloride in high yields. The present invention further provides a process for purification of cinacalcet hydrochloride.

Process for cinacalcet hydrochloride

The present invention provides novel crystalline forms of maraviroc phosphate, processes for their preparation and pharmaceutical compositions comprising them. The present invention also provides novel process for the preparation of maraviroc amorphous form and pharmaceutical composition comprising it.

Crystalline forms of maraviroc phosphate and process for maraviroc amorphous form

The present invention relates to process for the resolution of omeprazole. The present invention further provides a novel compound of enantiomers of omeprazole cyclic amine salt and a process for preparing it. The present invention also provides a solid of (R)- or (S)-omeprazole cyclic amine salt and a process for preparing it. The present invention also provides a process for the preparation of esomeprazole magnesium dihydrate substantially free of its trihydrate form. The present invention also provides a process for the preparation of recovery of chiral BINOL.

The present invention provides novel polymorphs of raltegravir potassium, processes for their preparation and pharmaceutical compositions comprising them. Thus for example, raltegravir potassium was added to water and stirred for 15 minutes, the solution was filtered on hiflo bed and the bed washed with water, the resulting solution was subjected to freeze drying at &#x2212;180 deg C. for 13 hours to give raltegravir potassium amorphous form.

Polymorphs of raltegravir potassium

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) ranging from about 4 &#x3bc;m to 15 &#x3bc;m and 90 volume-% of the particles (D) ranging from about 14 &#x3bc;m to 30 &#x3bc;m, to the methods for the manufacture of said crystalline particles, and to pharmaceutical compositions comprising said crystalline particles.

Hydrated form of erlotinib free base and a process for preparation of erlotinib hydrochloride polymorph form a substantially free of polymorph form B

4-[[6-chloro-2-[(4-cyanophenyl)amino]-4-pyrimidinyl]oxy]-3,5-dimethyl-benzonitrile is a key intermediate for the preparation of etravirine. The present invention provides a process for preparation of 4-[[6-chloro-2-[(4-cyanophenyl)amino]-4-pyrimidinyl]oxy]-3,5-dimethylbenzonitrile. The present invention also provides a novel process for the preparation of etravirine crystalline form I. The present invention further provides novel crystalline forms of etravirine, processes for their preparation and pharmaceutical compositions comprising them.

Process for etravirine intermediate and polymorphs of etravirine

The present invention provides a novel crystalline form of atazanavir sulfate, process for its preparation and to pharmaceutical composition containing it. In accordance with the present invention atazanavir sulfate was dissolved in methanol, to the solution was added ethyl acetate, the solid obtained was collected by filtration and dried to give atazanavir sulfate crystalline form H1.

Polymorph of atazanavir sulfate

The invention relates to a process for the preparation of stable lamivudine polymorph form and to a composition comprising thereof.

Process for preparing lamivudine polymorph form

The present invention provides a process for preparation of a key intermediate of valsartan in a pure form and use of this intermediate for the preparation of valsartan or a pharmaceutically acceptable salt in pure form.

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Hyderabad Telangana, India

Rapolu Raji Reddy