May 1, 2009
TEDA Tianjin, China, May 1, 2009: Asymchem Laboratories, Inc, a leading research-based contract manufacturer of API’s and intermediates, and Drug Products to the pharmaceutical industry, is pleased to announce the opening if its high potency Active Pharmaceutical Ingredient (API) in TEDA Tianjin, China.
This dedicated facility is sited at Asymchem’s TEDA Tianjin 1 location, and provides state-of-the art containment for production of potent API’s at an Occupational Exposure Level (OEL) of <0.1mg/m3/8hrs, validated by an expert independent assessor. The new facility allows Asymchem to operate two separate API manufacturing trains of 50 and 100L, and contains four independent breathing air lines per suite.
As part of the same dedicated facility is space for the future addition for smaller-scale research and production of oral dosage form, tablet and capsule, manufacturing that incorporate potent ingredients.
“We are pleased to expand our capabilities in process research and manufacturing into the potent compound arena, and provide our partners with cost-effective and quality-driven means for undertaking this type work in China” states Dr Hao Hong, CEO of Asymchem. “This new dedicated High Potency facility compliments our existing cGMP Pilot Plant in the Tianjin 2 site, which can achieve 1-10mg/m3/8hrs for compounds with less stringent requirements.”
Asymchem seeks to be a leader among Chinese-located manufacturing operations not only in facility design but also worker safety, and the Tianjin potent compound site was designed and validated by recognized and accredited experts in the potent compound community. As one of the largest and most respected pharmaceutical manufactures in China, Asymchem is pleased to extend its broad range of API and drug product capabilities to this exciting and rapidly emerging field of drug research and development.