DUNHUA, China, Oct. 2, 2015 /PRNewswire/ -- Jilin Asymchem Laboratories Co., Ltd., a custom contract manufacturer of APIs to the global pharmaceutical industry, today announced that it has successfully passed the Australian Therapeutic Goods Administration (TGA) inspection. The audit conducted from May 23rd to 27th was a first time regulatory inspection for the Dunhua site since coming online in 2011, triggered by an NDA filing by a US pharmaceutical company. This outcome adds onto the ever increasing successful track record of Asymchem's regulatory inspections, previously by the U.S. Food and Drug Administration (USFDA) for the Tianjin and Fuxin sites.
The Dunhua state-of-the-art facility started cGMP production in 2011 and has 658 m3 capacity, with an additional 37 m3 of autoclave capacity coming online by December 2015. The facility was built with the intention of maintaining a high degree of flexibility to support validation and supply via batch sizes from 100kg to 700kg. Products are regularly shipped to Europe and the U.S. from this facility.
"We are very proud to have confirmation of Asymchem's strong commitment to maintaining a robust quality system and hope this will be added assurance to our global customers for years to come," states Dr. Hao Hong, Chairman and CEO of Asymchem Group.
Asymchem is a custom research and contract manufacturer of cGMP intermediates and APIs for the global pharmaceutical industry, providing compliant and sustainable manufacturing solutions worldwide over the lifecycle of your drug. Founded in 1997, Asymchem employs 1,300 personnel within China over 4 sites. USFDA and TGA inspected.
SOURCE Asymchem Inc.