Abstract: 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.

Abstract: 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.

Abstract: The present invention relates to process for the preparation of highly pure Lenalidomide (I). The invention also relates to crystalline Form-SL obtained by the process of the present invention., the said Form-SL being substantially pure and characterized by X-ray powder diffraction pattern comprising of at least seven peaks selected from 7.061, 12.860, 16.531, 18.698, 27.925, 33.212, 34.187, 35.253, 35.921 and 38.765±0.1°2?; a single un-split °2? peak at 7.813±-.1°2?; and a three-way split °2? peak at 20.467±0.1°2?. The invention further relates to pharmaceutical compositions comprising crystalline Form-SL of Lenalidomide, which may be useful for the treatment of cancer.

Abstract: 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?° 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±0.20 2?°, DSC isotherm comprising the endothermic peaks ranging between 213 to 217° C. (Peak ?1) and 225 to 235° C. (Peak ?2) and IR absorption characteristic peaks at approximately 3278 cm?1, 1948 cm?1, 1871 cm?1, 1632 cm?1, 1164 cm?1, 1024 cm?1, 940 cm?1 and 742 cm?1 useful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment cancer.

Abstract: The present invention provides a process for preparing amorphous Cabazitaxel from the solvate form of Cabazitaxel. The present invention also provides novel diisopropyl ether solvate form of Cabazitaxel (I), and process for preparation thereof. Said amorphous Cabazitaxel and crystalline diisopropyl ether solvate of Cabazitaxel of the present invention can be utilized in preparing the pharmaceutical composition/s useful in the treatment of cancer.

Abstract: The present invention relates to a process for preparation of crystalline Form-SDI of Dasatinib (I). Said crystalline Form-SDI of Dasatinib is characterized by X-ray powder diffraction pattern comprising of at least seven 2?° peaks selected from the XRPD peak set of 5.8, 11.5, 12.7, 13.2, 17.3, 17.5, 18.1, 20.1, 20.5, 22.1, 25.4, 26.6, 26.8±0.20 2?°; IR spectrum having at least five absorption peaks selected from about 3390 cm?1, 2923 cm?1, 1621 cm?1, 1615 cm?1, 1537 cm?1, 1316 cm?1, 1061 cm?1, 815 cm?1 and 783 cm?1; and DSC isotherm comprising at least two endothermic peaks ranging between ?130° C. to 150° C., 160° C. to 175° C. or 280° C. to 290° C. The pharmaceutical compositions of the crystalline Form-SDI of Dasatinib or its hydrate thereof may be useful as an anti-cancer agent.

Abstract: The present invention provides a non-solvated amorphous form of (2?,5?,7?,10?,13?)-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?,5?,7?,10?,13?)-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. 1, and IR spectrum as per FIG. 3 and is useful as an active pharmaceutical in a pharmaceutical composition comprising thereof and has anti-cancer activity.

Abstract: 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-?, ? and ? 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. 1, 3 and 5, which are useful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment or prevention of autoimmune related disorder including multiple sclerosis.

Abstract: The present invention provides a process for preparing amorphous Cabazitaxel from the solvate form of Cabazitaxel. The present invention also provides novel diisopropyl ether solvate form of Cabazitaxel (I), and process for preparation thereof. Said amorphous Cabazitaxel and crystalline diisopropyl ether solvate of Cabazitaxel of the present invention can be utilized in preparing the pharmaceutical composition/s useful in the treatment of cancer.

Abstract: 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?° 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±0.20 2?°, DSC isotherm comprising the endothermic peaks ranging between 213 to 217° C. (Peak -1) and 225 to 235° C. (Peak -2) and IR absorption characteristic peaks at approximately 3278 cm?1, 1948 cm?1, 1871 cm?1, 1632 cm?1, 1164 cm?1, 1024 cm?1, 940 cm?1 and 742 cm?1 useful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment cancer.

Abstract: The present invention relates to an improved process for preparation of Dasatinib monohydrate Formula A, comprising the steps of: a) reacting the compound of Formula I with 1-(2-Hydroxyethyl)piperazine (Formula II) in the presence of acetonitrile solvent, an organic base and a phase transfer catalyst; b) heating the reaction mixture at 50-80° C.; c) adding water to the reaction mass obtained in step b); d) cooling the reaction mixture to a temperature below 35° C.; e) filtering and drying the material obtained in step d); f) optionally purifying the product obtained from step e); g) isolating the crystalline Dasatinib monohydrate.

Abstract: The present invention provide processes for the preparation of highly pure Bendamustine hydrochloride monohydrate of formula (I) The present application relates to Bendamustine hydrochloride monohydrate crystalline Form-SM characterized by X-ray powder diffraction pattern as depicted in FIG. 1 consisting peaks selected from the XRPD 2 theta degrees peaks at 7.42, 10.60, 11.17, 16.43, 17.94, 22.89, 26.33, 28.77, 30.28, 31.92, and 40.89±0.1 2?° having a purity of greater than 99.5% (by HPLC). The present application also provides a process for the preparation of highly pure Bendamustine hydrochloride monohydrate crystalline Form-SM useful in making pharmaceutical composition for the treatment of cancer or similar proliferative disorders.

Abstract: The present invention provides an industrially suitable process for the preparation of substantially pure 4-{4-[({[4-chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]phenoxy}-N-methylpyridine-2-carboxamide or Sorafenib and its tosylate salt, with a suitable impurity profile and without requirement of any additional purification steps. The present invention also provides Sorafenib base (II) as stable crystalline Form-SSB. The present invention further relates to a process for the preparation of crystalline Sorafenib tosylate Form-I which is free from contamination of any other polymorphic form of Sorafenib tosylate, for e.g. Form II or Form III, and does not involve any seeding requirement for crystallization step.

Abstract: The present invention provides an improved process for preparing N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazole carboxamide monohydrate or Dasatinib monohydrate (Formula A).

Abstract: 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. 1, is useful as an active pharmaceutical and has anti-androgenic activity.

Abstract: The present invention provides a non-solvated amorphous form of (2?,5?,7?,10?,13?)-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?,5?,7?,10?,13?)-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. 1, and IR spectrum as per FIG. 3 and is useful as an active pharmaceutical in a pharmaceutical composition comprising thereof and has anti-cancer activity.

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

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

Abstract: 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-?, ? and ? 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. 1, 3 and 5, which are useful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment or prevention of autoimmune related disorder including multiple sclerosis.

Abstract: 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. 1, is useful as an active pharmaceutical and has anti-androgenic activity.