Pharmaron Earns CFDA GLP Certification for Toxicology Facility

BEIJING – March 5, 2014 — Pharmaron announced today that the company’s GLP toxicology facilities in Beijing have earned a certificate of full GLP compliance from the Chinese Food and Drug Administration (CFDA) based upon a thorough inspection of its facilities, operating procedures and technical competency of the staff. Pharmaron is currently under contract with Sponsors wishing to file INDs in China as the result of this news.

“This certification by the CFDA is a reflection of Pharmaron’s commitment to fully comply with the CFDA’s GLP standards. It provides another avenue for our Sponsors to submit regulatory data from our facilities. Pharmaron is well positioned today to provide toxicology and regulatory expertise to our customers intending to include the China market in their drug development strategy,” commented Pharmaron Chairman and CEO, Dr. Boliang Lou.

Pharmaron has a long-standing track record of performing acute and chronic GLP toxicology in China for U.S. and international Sponsors wishing to file INDs with the U.S. FDA. Addition of the CFDA-certified designation further secures Pharmaron’s leading position in GLP toxicology in China and strengthens its integrated and IND-enabling service capability and capacity that provides a custom-designed, project management team to move compounds from discovery chemistry and DMPK through GLP toxicology and IND support.