FDA letter prompts API manufacturer to choose partner
ChemWerth to Rebuild Quality Systems for Xi’An Libang Pharmaceutical Co.
Chinese pharmaceutical company appoints quality expert in response to FDA warning letter
Woodbridge, CT, March 11, 2010 – Xi’An Libang Pharmaceutical Co. Ltd., in Xi’An, China, has appointed ChemWerth as their consultant for the purpose of responding to an FDA warning letter. Mr. Jeffery Hangartner, a former FDA investigator who now heads a regulatory team for ChemWerth in China, will serve as an independent, third party auditor responsible for overseeing the rebuilding of the Xi’An Libang quality system.
Mr. Hangartner will also be responsible for conducting a cGMP training program for the Xi’An Libang staff. He brings over 14 years of experience working at the FDA and has been instrumental in conducting customer driven, six-system audits, FDA inspections, and installing cGMP improvement programs at several Chinese factories.
Xi’An Libang has chosen ChemWerth because of its ongoing commitment to achieving the highest standards of cGMP compliance, in addition to ensuring that the active pharmaceutical ingredients (APIs) it produces are of the highest quality for its customers.
ChemWerth is looking forward to marketing ropivacaine hydrochloride, fulvestrant and other active pharmaceutical ingredients for Xi’An Libang in the future.
ChemWerth is a full service Generic Active Pharmaceutical Ingredient development and supply company specializing in oral, injectable, topical and veterinary products at competitive prices. Founded in 1982 to supply the emerging generic pharmaceutical industry with sources of reliable, high quality APIs, ChemWerth represents numerous FDA approved facilities in China, as well as a growing number of cGMP manufacturing facilities in the United States, Europe and India. For more information about the company please visit www.chemwerth.com.
Posted: March 2010