Apicore US LLC

Apicore, LLC

Rk Pharma Inc.

Rk Pharma Solutions LLC

Jayaraman Rao Kannapan

Ravishanker Kovi

Ashish Naik

Sanjay F Thakor

Ananda Babu Thirunavakarasu

Veerabhadra Rao Bobbili

Piyush D Fadadu

Shivnath Sahebrao Patil

Hemant Mande

Rajesh A Patel

KeshavRao Rapole

Gaurav Yadav

Talluri Bhushaiah Chowdary

Anand Vijaykumar Mantri

Gaurav Kulkarni

Khichi Kuldip Fatehlal

Vasanthakumar G Ramu

Alaparthi Lakshmi Prasad

Saiyed Akeel Ahmed Shakeel Ahmed

N V Raghavalu Dusanapudi

Muralikrishna Madala

Murali Krishna Madala

Talluri Buhshaiah Chowdari

Piyush B Thumar

Chirag Vasantlal Shah

Ritesh H Panchal

Varun L Zambare

Dhakhada Chetana Bharatbhai

The present application provides processes for the purification of ferric carboxymaltose, the process includes the steps of dissolving crude ferric carboxymaltose in a first solvent; charging the ferric carboxymaltose solution in a reaction vessel with a second solvent and precipitating therefrom a ferric carboxymaltose precipitate; and isolating pure ferric carboxymaltose from the ferric carboxymaltose precipitate.

Purification process of ferric carboxymaltose

Novel processes for making the N-pyrrazole substituted 2-adenosine derivative regadenoson and a novel polymorph thereof. The novel polymorph of regadenoson designated form H and drug substances and pharmaceutical compositions including the novel polymorph H are disclosed.

Process of making regadenoson and novel polymorphs thereof

Processes are disclosed for making vortioxetine and pharmaceutically acceptable salts thereof. A propylene glycol solvate of vortioxetine hydrobromide is disclosed. A novel crystalline form of vortioxetine hydrobromide propylene glycol solvate, designated form AC1, is disclosed along with a method for making same. Form AC1 may be characterized by an x-ray powder diffraction pattern with peaks at about 19.64, 22.85, 25.51, 29.57, 30.18&#xb1;0.2 degrees 2-theta.

Process and novel polymorphic form of vortioxetine and its pharmaceutically acceptable salts

Novel polymorphs of rucaparib camsylate include Form alpha having XRPD peaks at diffraction angles (2&#x3b8;) of 6.14&#xb1;0.2, 12.41&#xb1;0.2, 15.34&#xb1;0.2, 15.95&#xb1;0.2, 16.36&#xb1;0.2, 16.51&#xb1;0.2 and 19.67&#xb1;0.2, Form beta having XRPD peaks at diffraction angles (2&#x3b8;) of 6.86&#xb1;0.2, 9.58&#xb1;0.2, 12.75&#xb1;0.2, 14.56&#xb1;0.2, 15.05&#xb1;0.2, 20.76&#xb1;0.2 and 22.45&#xb1;0.2, and Form gamma having XRPD peaks at diffraction angles (2&#x3b8;) of 9.5&#xb1;0.2, 12.73&#xb1;0.2, 14.77&#xb1;0.2, 15.16&#xb1;0.2, 20.62&#xb1;0.2, 22.33&#xb1;0.2, 22.63&#xb1;0.2 and 27.29&#xb1;0.2. Methods are disclosed for the preparation of such polymorphic forms and pharmaceutical compositions containing such polymorphic forms. A method is disclosed for preparing a highly pure Form B of rucaparib camsylate. Pharmaceutical compositions containing highly pure Form B prepared by the method are disclosed.

Polymorphs of rucaparib camsylate and methods of making same

Process of making regadenoson and novel polymorph thereof

Processes are provided for the preparation of a stable polymorphic form C of regadenoson, the process involving steps of a) obtaining a solution of regadenoson in benzyl alcohol solvent, b) maintaining the reaction mixture of step a) to about 10&#xb0; C. to about 90&#xb0; C., and c) isolating the stable polymorphic form C of regadenoson. Polymorphic form C may be characterized by an x-ray powder diffraction pattern with peaks at about 6.1, 10.2, 10.6, 19.0 and 25.4.&#xb1;0.2 degrees 2-theta.

Polymorph of regadenoson and process for preparation thereof

Novel crystalline ponatinib hydrochloride forms designated Form alpha and Form beta are disclosed. Form alpha is characterized by data selected from an XRPD pattern with peaks at about 6.5, 9.0, 12.25, 14.4, 16.70, 19.6, 22.2, 24.5, 28.2&#xb1;0.2 degrees 2-theta; an XRPD pattern substantially as depicted in FIG.; and/or a combination thereof. Form beta is characterized by data selected from an XRPD pattern with peaks at about 10.7, 15.2, 15.8, 16.4 23.1, 25.0, 27.8&#xb1;0.2 degrees 2-theta; an XRPD pattern substantially as depicted in FIG.; and/or combinations thereof. Processes for making Form alpha and Form beta are disclosed.

Polymorphs of ponatinib hydrochloride

Methods are disclosed for making 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl]benzamide, intermediates and pharmaceutically acceptable salts thereof.

Processes for making ponatinib and intermediates thereof

Racemization-free methods are disclosed for the synthesis of carfilzomib. Novel intermediates and methods of making carfilzomib employing fragment condensation using the novel intermediates are disclosed. Amorphous carfilzomib and methods of making same are disclosed.

Methods of making carfilzomib and intermediates thereof

Novel synthetic approaches to make 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl]benzamide, intermediates and pharmaceutically acceptable salts thereof are provided.

Methods of making saxagliptin, pharmaceutically acceptable salts and hydrates thereof and intermediates thereof.

Process for preparing saxagliptin and its novel intermediates useful in the synthesis thereof

Methods are provided for making pharmaceutical-grade cis-2-methylspiro(1,3-oxathiolane-5,3')quinuclidine and pharmaceutically acceptable salts thereof by isomerizing racemic 2-methylspiro(1,3-oxathiolane-5,3&#x2032;)quinuclidine to cis-2-methylspiro(1,3-oxathiolane-5,3&#x2032;)quinuclidine and subsequent purification of the C-MSOQ by salt formation with inexpensive and commercially available material such as sulfuric acid. Purification methods are disclosed which employ an organic solvent/water system and recrystallization with an organic solvent such as acetone.

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Vadodara, India

Jayaraman Rao Kannapan