Chiral Quest Files First USDMF

CAMBRIDGE, U.K. - Aug. 8, 2013 - PRLog --  

First USDMF Filed by Chiral Quest.

 

Suzhou, Jiangsu, PR China.  April 15^th, 2013.

 

 

Chiral Quest (Suzhou) Company Limited has filed a Type II Drug Master File (DMF) with the United States Food and Drug Administration (USFDA) for (S)-3-Methylamino-1-(thiophene-2-yl)propan-1-ol (S-MMAA), as manufactured at Chiral Quest’s facility in Jiangxi Province, PR China.  S-MMAA is an advanced intermediate used in the manufacture of Cymbalta (Duloxetine); a serotonin-norepinephrine reuptake inhibitor used for the treatment of major depressive disorder and generalized anxiety disorder.

The DMF was filed with the USFDA 22^nd January 2013 and has been assigned reference number 26862.

“This is the first DMF filed by Chiral Quest in its 12 year history and is a significant milestone,” said James Wu., Chief Executive Officer.  “The company will file another 3-4 DMF’s in the near future, for both intermediates and API’s.  This is part of our strategy to introduce GMP at the Jiangxi site and provision of complex API’s to the growing generic market”.

 

About Chiral Quest

 

Chiral Quest Corp., a private company with headquarters in Suzhou, Jiangsu, China, is a technology-based company creating solutions for the pharmaceutical industry, assisting Pharmaceutical and Biotechnology companies to develop processes for the manufacture of their candidate drugs. The company’s proprietary technology platform and products address customer needs through the integration of proprietary chiral catalysts and novel processes in the manufacture of pharmaceutical intermediates and API’s.

Chiral Quest operates R&D, Quality Assurance, Finance and Administration in Suzhou, China, and commercial manufacturing in Jiangxi Province, China, with offices near Princeton, USA and Cambridge, UK.  The company currently employs 150 scientists and support staff, and plans during the following year to expand its technical personnel base to over 250 employees.

 

For further information contact:

 

Marc Zhu

Chiral Quest (Suzhou) Co. Ltd

9/F, B1, Biobay,

218 Xing Hu Street,

Suzhou Industrial Park, Suzhou,

215123, China

Tel: +86-512-62956066; Fax: +86-512-62956065

Email: mzhu@cqpharm.com