TEDA TIANJIN, China, June 4 /PRNewswire/ -- Asymchem Laboratories, Inc., a leading research-based contract manufacturer of intermediates, API's and drug products to the pharmaceutical industry, is pleased to announce the issuance by the Tianjin branch of the Chinese State Food and Drug Administration (sFDA), a manufacturing certificate for drug products to our Tianjin 2 site. This qualifies Asymchem to manufacture oral solid dosage forms including tablets, capsules, and pellets.
Asymchem offers preclinical and drug product programs that include preformulation and formulation development, and clinical supply manufacturing of oral dosage forms. Housed in a 250 m2 state-of-the-art facility in Asymchem's Tianjin 2 site, Asymchem's drug product manufacturing facility is capable of producing up to kilogram scale of tablets or capsules per batch to support phase 1 and phase 2 clinical studies. Separate facility of similar scale exists for manufacture of dosage forms containing highly potent or cytotoxic compounds. Meanwhile, a much larger drug product facility for commercial manufacturing is being built and expected to be operational by 2Q 2010.
"We feel drug product capabilities to support all phases of our collaborator's research, development, and manufacturing are a logical extension of our long-standing capabilities in API development and manufacturing," states Dr. Hao Hong, CEO of Asymchem. "Our recent successful sFDA audit demonstrates that we bring the same focus on quality and regulatory compliance to our drug product programs that we have always brought to our API programs."
Dr. Xiaorong He, director of Formulation Development for Asymchem adds: "Operating to the highest technical and regulatory standards is part of the Asymchem culture, and our recent certification demonstrates our commitment to these ideals."