Abstract: The present invention provides process for preparation of highly pure Fingolimod hydrochloride (I), without involving the use of column chromatographic purification in the entire process. Fingolimod hydrochloride (I) obtained by the process of present invention may be useful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment of autoimmune related disorder including multiple sclerosis.

Abstract: The present invention provides process for preparation of highly pure Fingolimod hydrochloride (I), without involving the use of column chromatographic purification in the entire process. Fingolimod hydrochloride (I) obtained by the process of present invention may be useful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment of autoimmune related disorder including multiple sclerosis.

Abstract: The present invention provides process for preparation of Fingolimod hydrochloride (I). Fingolimod hydrochloride (I) as Form-? obtained by the process of present invention may be useful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment of autoimmune related disorder including multiple sclerosis.

Abstract: The present application relates to an improved process for preparation of Enzalutamide (I). The present application also relates to an improved process for the preparation of substantially pure Enzalutamide (I) having purity of greater than 99.5%. The present application also relates to a novel process for the preparation of Enzalutamide intermediate useful in the industrially viable synthesis of Enzalutamide.

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 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 process for preparation of crystalline Bortezomib (Ia) as its monohydrate which is designated as crystalline Form-SB and characterized by having water content ranging between 3.5-6.0% w/w; X-ray powder diffraction pattern comprising characteristic 2?° peaks selected from the XRPD peak set of 5.6, 7.5, 9.8, 10.2, 11.3, 15.1, 18.0, 20.5, 21.5 and 23.6±0.20 2?°, wherein peaks at 9.8 and 11.39±0.20 2?° are un-split and 100% intensity peak is present at 5.6±0.20 2?°, DSC isotherm comprising the endothermic peaks ranging between 45 to 60° C. (Peak-1) and 175 to 185° C. (Peak-2) and IR absorption characteristic peaks approximately at 3387 cm?1, 3304 cm?1, 2953 cm?1, 2927 cm?1, 2868 cm?1, 1627 cm?1, 1455 cm?1, 1400 cm?1, 1201 cm?1, 1150 cm?1, 1020 cm?1, 747 cm?1 and 702 cm?1 and Raman absorption spectra having characteristic peaks approximately at 3066 cm?1, 1583 cm?1, 1528 cm?1, 1281 cm?1, 1213 cm?1, 1035 cm?1, 1022 cm?1 and 1004 cm?1.

Abstract: The present invention provides process for preparation of Fingolimod hydrochloride (I). Fingolimod hydrochloride (I) as Form-? obtained by the process of present invention may be useful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment of autoimmune related disorder including multiple sclerosis.

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 process for preparation of crystalline Bortezomib (Ia) as its monohydrate which is designated as crystalline Form-SB and characterized by having water content ranging between 3.5-6.0% w/w; X-ray powder diffraction pattern comprising characteristic 20° peaks selected from the XRPD peak set of 5.6, 7.5, 9.8, 10.2, 11.3, 15.1, 18.0, 20.5, 21.5 and 23.6±0.20 2?°, wherein peaks at 9.8 and 11.39±0.20 2?° are un-split and 100% intensity peak is present at 5.6±0.20 2?°, DSC isotherm comprising the endothermic peaks ranging between 45 to 60° C. (Peak-1) and 175 to 185° C. (Peak-2) and IR absorption characteristic peaks approximately at 3387 cm?1, 3304 cm?1, 2953 cm?1, 2927 cm?1, 2868 cm?1, 1627 cm?1, 1455 cm?1, 1400 cm?1, 1201 cm?1, 1150 cm?1, 1020 cm?1, 747 cm?1 and 702 cm?1 and Raman absorption spectra having characteristic peaks approximately at 3066 cm?1, 1583 cm?1, 1528 cm?1, 1281 cm?1, 1213 cm?1, 1035 cm?1, 1022 cm?1 and 1004 cm?1.

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 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.

Abstract: The present invention provide processes for the preparation of Bendamustine hydrochloride monohydrate of formula (I) The present application also provides a process of purification of Bendamustine hydrochloride or monohydrate to get substantially pure Bendamustine hydrochloride monohydrate crystalline Form-SM. The said Bendamustine hydrochloride monohydrate crystalline Form-SM is characterized by X-ray powder diffraction pattern comprising at least 5 characteristic 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, 40.89±0.1 2?°. The present application also provides a process for the preparation of Bendamustine hydrochloride monohydrate crystalline Form-SM useful in making pharmaceutical composition for the treatment of cancer or similar proliferative disorders.

Abstract: The present invention relates to an improved process for preparation of the non-steroidal aromatase inhibitor drug, Letrozole of formula (I) and its intermediates, 4-[1-(1,2,4-triazolyl)methyl]-benzonitrile of formula (IV) and 4-[1-(1,2,4-triazolyl)methyl]-benzonitrile hydrochloride of formula (VII), all having a purity of ?99%, which is simple, convenient, economical, does not use hazardous chemicals and industrially viable.