Apotex got an ultimatum from the FDA: Fix your manufacturing problems, or forget introducing new meds in the U.S. According to a letter the FDA sent the Canadian generics maker late last month, agency inspectors found a litany of problems at a Etobicoke, Ontario, plant. Until the agency can confirm those problems are fixed, Apotex could see its drug apps stalled at the FDA--and it might even find that drugs produced at that plant won't be allowed into the U.S., the letter said.
According to the FDA, the plant has had an unusually high number of failed batches, and Apotex didn't investigate those failures thoroughly enough to satisfy inspectors. And the pattern of batch rejection "demonstrates a lack of adequate process controls and raises significant concerns" that those processes can consistently turn out high-quality products, the letter said (as quoted by Reuters).
As you know, Apotex is one of a growing group of drugmakers under FDA crackdown. The agency's inspectors have uncovered problems at Sun Pharma's U.S. subsidiary, Caraco Pharmaceuticals, and at India's Ranbaxy Laboratories. FDA had Caraco products seized by U.S. Marshals, and Ranbaxy's drugs were stuck on the dock, prevented from entering the U.S. Both companies are negotiating with the agency to get their meds back on the U.S. market.
- see the Reuters story