TIANJIN, China, Sept. 5, 2017 /PRNewswire/ -- 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 a pre-approval inspection (PAI) by the US Food and Drug Administration (FDA). The 5 day inspection was conducted between March 27-31, 2017, triggered by a customer's New Drug Application (NDA) filing of a cGMP intermediate. The Dunhua site was found to be compliant with the principles and guidelines of Good Manufacturing Practice (GMP) for commercial activities, and resulted in no Form 483 observations. This was Asymchem Dunhua's first US FDA inspection.
Previous PAI and cGMP inspections by the US FDA were conducted in 2014 at Asymchem's Tianjin 1, Tianjin 2, and Fuxin sites (one week for each site), of which only one Form 483 was issued to the Fuxin site with a minor observation.
Dr. Hao Hong, CEO and Chairman of the Board of Asymchem Group, states, "We are very pleased with the positive results from this US FDA PAI of Asymchem's Dunhua manufacturing facility. We are committed to and believe that our compliance history demonstrates our commitment to constantly improve our quality and compliance program to meet the highest quality standards in the manufacture of API's."
Asymchem is a USFDA and TGA inspected 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.