Shilpa Medicare Limited

Prashant Purohit

Vimal Kumar Shrawat

Vinod Kumar Singh

Akshay Kant Chaturvedi

Rafiuddin Dr

Sriram Rampalli

Rafiuddin

Veereshappa

Lav Kumar Upalla

Chaturvedi Akshay Kant

Krishna Kumar Ramachandrula

Mohanrao Seshagiri Vijaya Murali

Lavkumar Upalla

Pradeep Pothana

Karri Papa Rao

The present invention relates to a process for the preparation of 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide or Regorafenib (I).  The present invention further relates to a process for the purification of 4-[4-({[4-chloro-3-(trifluoromethyl) phenyl] carbamoyl} amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide or Regorafenib (I) to provide highly pure material. The present invention further relates to a process for the preparation stable crystalline material of 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methyl pyridine-2-carboxamide or Regorafenib (I) useful in the preparation of pharmaceutical compositions for the treatment of cancer.

Process for the preparation of regorafenib and its crystalline forms

The present invention provides process for preparation of Crystalline Erlotinib HCl (I) Form-SE characterized by X-ray powder diffraction pattern comprising at least 5 characteristic 2&#x3b8;&#xb0; peaks selected from the XRPD peak set of 5.60, 10.00, 11.40, 13.00, 13.50, 15.20, 18.40, 20.65, 21.86, 23.5, 31.80, 32.13, 32.80, 34.40&#xb1;0.20 2&#x3b8;&#xb0;, DSC isotherm comprising the endothermic peaks ranging between 213 to 217&#xb0; C. (Peak &#x2212;1) and 225 to 235&#xb0; C. (Peak &#x2212;2) and IR absorption characteristic peaks at approximately 3278 cm, 1948 cm, 1871 cm, 1632 cm, 1164 cm, 1024 cm, 940 cmand 742 cmuseful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment cancer.

Crystalline erlotinib hydrochloride process

The present invention provides a non-solvated amorphous form of (2&#x3b1;,5&#x3b2;,7&#x3b2;,10&#x3b2;,13&#x3b1;)-4-acetoxy-13-({(2R,3S)-3[ (tert-butoxy carbonyl) amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1-hydroxy-7,10-dimethoxy-9-oxo-5,20-epoxytax-11-en-2-yl benzoate or Cabazitaxel (I), and process for preparation thereof. The present application also provides a non-solvated amorphous form of (2&#x3b1;,5&#x3b2;,7&#x3b2;,10&#x3b2;,13&#x3b1;)-4-acetoxy-13-({(2R,3S)-3[ (tert-butoxy carbonyl) amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1-hydroxy-7,10-dimethoxy-9-oxo-5,20-epoxytax-11-en-2-yl benzoate or Cabazitaxel (I) having an XRPD pattern as per FIG., and IR spectrum as per FIG.and is useful as an active pharmaceutical in a pharmaceutical composition comprising thereof and has anti-cancer activity.

Process for preparing amorphous cabazitaxel

The present invention provides crystalline polymorphic forms of Fingolimod HCl (I) and processes for preparation thereof. The application provides processes for preparation of crystalline polymorphic forms-&#x3b1;, &#x3b2; and &#x3bc; substantially free from process related impurities. The crystalline polymorphic forms of Fingolimod HCl (I) obtained by the processes according to the present invention having an XRDP pattern as per FIGS.and, which are useful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment or prevention of autoimmune related disorder including multiple sclerosis.

Fingolimod polymorphs and their processes

The present invention relates to an improved process for preparation of Dasatinib monohydrate Formula A, comprising the steps of: 

Process for preparing dasatinib monohydrate

The present invention provide processes for the preparation of N-[4-Cyano-3-(trifluoro methyl)phenyl]-3-[(4-fluorophenyl)sulphonyl]-2-hydroxy-2-methyl propanamide (I). The present application also provides a method of purification of N-[4-Cyano-3-(trifluoro methyl)phenyl]-3-[(4-fluorophenyl)sulphonyl]-2-hydroxy-2-methyl propanamide (I) using ethyl acetate solvent resulting in the product, substantially free from process related impurities A, B, C and D. The crystalline product of the process according to the present invention having an XRDP pattern as per FIG., is useful as an active pharmaceutical and has anti-androgenic activity.

Process for preparing bicalutamide

The present invention provide process of preparation of (2R,3S)&#x2014;N-carboxy-3-phenylisoserine, N-tert-butyl ester, 13-ester with 5(&#x3b2;)-20-epoxy-1,2(&#x3b1;),4,7(&#x3b2;),10(&#x3b2;),13(&#x3b1;)-hexa hydroxy tax-11-en-9-one 4-acetate 2-benzoate or docetaxel and its trihydrate (I) 

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Raichur, India

Prashant Purohit