Apicore US LLC

Rk Pharma Solutions LLC

Rk Pharma Inc.

Apicore, LLC

Ravishanker Kovi

Jayaraman Rao Kannapan

Satyam Nampalli

Peter Xavier Tharial

Jayaraman Kannappan

Sanjay F Thakor

Ashish Naik

Ananda Babu Thirunavakarasu

Shivnath Sahebrao Patil

Veerabhadra Rao Bobbili

Hemant Mande

Rajesh A Patel

Piyush D Fadadu

KeshavRao Rapole

Gaurav Yadav

Gaurav Kulkarni

Anand Vijaykumar Mantri

Talluri Bhushaiah Chowdary

Varun L Zambare

Hardik Vyas

Muralikrishna Madala

Murali Krishna Madala

Talluri Buhshaiah Chowdari

Chirag Vasantlal Shah

Brijesh Patel

Ritesh H Panchal

Dusanapudi Naga Venkata Raghavulu

Jayraman Kannappan

Thupalli Ajey Kumar Reddy

Raghu Rami Reddy Kasu

Prasad Vure

Raghu Kasu

Thupalli Ajeykumar Reddy

Vamshi Yekkanti

Rahul Dixit

Sanjaysinh Fatesinh Thakor

Sai Saisuryanarayana Donthukurthi

Yekkanti Vamshi

Saiyed Akeel Ahmed Shakeel Ahmed

Shivam Saroj

Piyush Fadadu

Srikrishna Apar

Sandeep Aher

Chowdari Bhushaiah Talluri

Aditya Khanvilkar

Govind Ahirrao

George Roby Thomas

Nirmal Chaitanya Indravadanbhai

Patel Mitesh Manubhai

Daxeshkumar Prakashbhai Patel

Piyush B Thumar

Dhakhada Chetana Bharatbhai

Khichi Kuldip Fatehlal

Vasanthakumar G Ramu

Alaparthi Lakshmi Prasad

N V Raghavalu Dusanapudi

Jayaraman Kannapan

The invention relates to an improved composition of ferric maltol or ferric trimaltol for the treatment of iron deficiency, wherein the composition comprises the active ferric maltol or ferric trimaltol lower than 60% of the total composition weight. The compositions further can be a capsule or tablet or any other pharmaceutical solid dosage form, preferably a capsule in a hard gelatin in a size of 0 or 1, for oral administration.

Composition of ferric maltol for oral administration

The present application provides method for producing methylene blue that includes the steps of providing a reaction mixture having one or more methylene blue intermediates; precipitating metal from the reaction mixture; and producing therefrom crude methylene blue. The crude may further be purified, resulting in methylene compounds having low impurities, preferably having a purity greater than about 97%, having Azure B impurity no greater than 2.5%, and/or a total metal content no greater than 77 ppm. Formulations containing such compounds are also provided.

Process for the purification of methylene blue

The present application provides stable ready-to-use injectable formulations of melphalan, methods for preparing storage-stable, ready-to-use injectable formulations that include melphalan, which are easy to administer without need of any reconstitution step and has a desirable solubility, stability, and safety profile. In other embodiments, provided are storage-stable, ready-to-use, injectable liquid parenteral formulations that include melphalan and other pharmaceutically acceptable excipients.

Ready to use injectable formulations of melphalan and processes for preparation thereof

Liquid parenteral formulations are provided that include tigecycline and at least one or more pharmaceutically acceptable excipient or adjuvant, where the formulation is ready to use without additional steps for reconstitution at the time of administration.

Storage-stable ready-to-use formulations of tigecycline

The present application provides improved processes for the synthesis of eribulin intermediate, which generally comprise the steps of: a) De-protecting the eribulin-enone (compound 1) in tetrahydrofuran by using TBAF solution, buffered with imidazole HCl in the presence of molecular sieve and sodium sulphate to get an insitu mixture of eribulin-dione diastereomer at C12 carbon (compound 2). Then ketalization may be performed of eribulin-dione insitu intermediate containing mixture of diastereomer at C12 carbon (compound 2) with PPTS in dichloromethane to yield eribulin-diol (compound 3).

Process for the preparation of eribulin mesylate intermediate

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

Methods for preparing degarelix acetate are provided that include the steps of providing a suitable resin; deprotecting the resin with a diethylenetriamine solution; reacting sequentially the deprotected resin with different Fmoc protected amino acids; deprotecting the amino acid in each sequence with a diethylenetriamine solution in a stepwise fashion to yield a degarelix crude compound; and purifying the degarelix crude compound to yield pharmaceutically acceptable degarelix acetate. Methods of preparing degarelix acetate-mannitol premix and the resulting degarelix acetate-mannitol premix are also provided.

Process for the preparation of Degarelix acetate and Degarelix acetate-mannitol premix

A process for the preparation of hydroxocobalamin hydrochloride. More particularly the present application relates to improved process for the preparation of Hydroxocobalamin hydrochloride. In addition the present application also relates to process for the preparation of novel amorphous form. This application particularly relates to a process for the industrial manufacture of hydroxocobalamin hydrochloride from cyanocobalamin. The present application also relates to the improvement in yield with better purity of Hydroxocobalamin hydrochloride.

Process for the preparation of hydroxocobalamin hydrochloride

A stable, ready-to-use injectable solution including thiotepa and one or more pharmaceutically acceptable solvents, co-solvents, and/or solubilizing agents. Formulations retain at least 90% and as high as 99% of the purity of thiotepa as measured by HPLC after storage at 25&#xb0; C./60% RH for a period of 7 days. Certain formulations retain at least 99% of the purity of thiotepa as measured by HPLC after storage for at least six months at 2-8&#xb0; C.

Storage-stable ready-to-use injectable formulations of thiotepa

The present application provides methods for the synthesis of intermediates in the synthesis of Safinamide or a pharmaceutically acceptable salt thereof herein Safinamide Mesylate, that is substantially free of impurities.

Process for the preparation of safinamide mesylate intermediate

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

Isosulfan blue and processes for the preparation thereof are provided. A process is also provided for preparation of the intermediate, 2-chlorobenzaldehyde-5-sulfonic acid, sodium salt of formula (2), used in the preparation thereof and a procedure for the isolation of benzaldehyde-2, 5-disulfonic acid, di-sodium salt of the formula (3). Also provided is a process for the preparation of an isoleuco acid of formula (4), which upon oxidation gives rise to isosulfan blue of pharmaceutical grade which can be used for preparation of pharmaceutical formulations. The isolation and purification procedures provided in the process provide substantially pure isosulfan blue with HPLC purity 99.5% or greater.

Process for preparation of isosulfan blue

Isosulfan blue and processes for the preparation thereof are provided. A process is also provided for preparation of the intermediate, 2-chlorobenzaldehyde-5-sulfonic acid, sodium salt of formula (2), used in the preparation thereof and a procedure for the isolation of benzaldehyde-2,5-disulfonic acid, di-sodium salt of the formula (3). Also provided is a process for the preparation of an isoleuco acid of formula (4), which upon oxidation gives rise to isosulfan blue of pharmaceutical grade which can be used for preparation of pharmaceutical formulations. The isolation and purification procedures provided in the process provide substantially pure isosulfan blue with HPLC purity 99.5% or greater.

Process for the preparation of isosulfan blue

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

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Monroe, NJ, United States of America

Ravishanker Kovi