TIANJIN, China, Nov. 30, 2017 — Asymchem Laboratories (Tianjin) Co., Ltd. (SHE: 002821, “Asymchem”) today announced that its API facility in Dunhua city, Jilin province, P. R. China (“Dunhua”), has successfully passed an inspection for GMP compliance by the Korean Ministry of Food and Drug Safety (MFDS). The 3-day inspection was conducted between September 5-7, 2017 for a customer specific intermediate product which is manufactured, packed and distributed by Asymchem's Dunhua site. The site was found to be compliant with the principles and guidelines of Good Manufacturing Practice (GMP) for commercial activities. This was Asymchem Dunhua's first Korean MFDS inspection.
Dr. Hao Hong, CEO and Chairman of the Board of Asymchem Group, responded by stating, “We are encouraged by the continued success of agency audits for the Dunhua manufacturing site, and remain committed to improve our quality programs to ensure continued compliance to meet the highest quality standards in the manufacture of API's”.
Asymchem is a CMC CDMO with over 20 years' expertise in developing innovative and sustainable processes for development to commercial APIs and HPAPIs. Operating out of six state of the art facilities in China and proficient in a number of niche technologies, including biotransformation, flow chemistry, highly-potent compounds, asymmetric synthesis, high-pressure and low- temperature chemistry, Asymchem is the main partner of choice for the global pharmaceutical industry.
SOURCE Asymchem Laboratories (Tianjin) Co., Ltd.
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