GMPs

Teva, Mylan to Participate in FDA Secure Supply Chain Pilot

Generic drug giants Teva and Mylan are just some of the 13 companies tapped by the FDA to participate in its Secure Supply Chain Pilot Program, an initiative five years in the making that will grant the companies’ U.S. product imports expedited treatment. Read More

China Pushes Pharma to Comply With Revised GMPs

The China Food and Drug Administration is renewing its push to have all manufacturers of blood products, vaccines and sterile injectables obtain a revised good manufacturing practices (GMP) certificate. Read More

RedHill, IntelGenx Get Complete Response Letter for Migraine Drug

Israeli-owned RedHill Biopharma and Canada’s IntelGenx have received a complete response letter from the FDA for their RHB-103 migraine drug, which cites problems with the pharma partners’ third-party chemistry, manufacturing and controls, packaging and labeling issues. Read More