Successful USFDA inspection of Asymchem Fuxin 1 carbapenem manufacturing facility
Published: Jun 01, 2018
TIANJIN, China, June 1, 2018 /PRNewswire/ -- Asymchem, a leading custom manufacturer of Intermediates and API's for the life sciences industry, today announced that its Fuxin 1 site, a dedicated carbapenem manufacturing facility, successfully passed the U.S. Food and Drug Administration (USFDA) general GMP reinspection conducted between March 12-15, 2018. No Form 483 was issued. Previous FDA inspections of Fuxin 1 took place in 2011 and 2014.
Asymchem's Fuxin, P. R. China site produces the carbapenem intermediate Enol Phosphate (ertapenem, meropenem and tebipenem), for which Asymchem holds an active Drug Master File, as well as other carbapenem intermediates. The Fuxin site has manufactured under cGMP conditions since 2010.
Asymchem will expand its carbapenem production capacity with the opening of Dunhua 2 site in April 2019. Validation and subsequent manufacture of the generic Ertapenem and Imipenem API's as well as other new carbapenems is slated to begin first half of 2019. The Fuxin 1 site will continue to manufacture in parallel.
On the outcome of the inspection, Dr. Hao Hong, Chairman and CEO of Asymchem Group, states "This is very satisfying outcome which confirms Asymchem's commitment and ability to meet the highest quality standards in the manufacturing of GMP products. I am very proud of the robust system implemented by Asymchem's QA team, and will continuously improve our standards for our customers moving forward."
Asymchem is a full service CMC CDMO of API's for the global pharmaceutical industry, providing compliant and sustainable manufacturing solutions worldwide over the lifecycle of a drug. Capabilities include dedicated HPAPI, in-house enzyme evolution and fermentation for biotransformations, end-to-end continuous flow development and application, hydrogenation, cryogenic capabilities, dedicated carbapenem manufacture, and others. Founded in 1997, Asymchem employs 2820 personnel within China over 6 manufacturing sites. The company has been USFDA, TGA, CFDA and MFDS inspected.
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