- Earlier this month, the FDA yanked tentative approvals from Ranbaxy, which was supposed to market generic versions of Nexium and Valcyte.
- The revocation was based on manufacturing deficiencies at Ranbaxy's manufacturing facilities.
- Ranbaxy responded by suing in court to stop competitors Endo and Dr. Reddy's Laboratories from stepping in, but a federal judge has rejected Ranbaxy's bid.
As of now, Dr. Reddy's and Endo can move forward and market generic versions of Nexium and Valcyte.
But this case speaks to a broader problem in the arena of Indian generics manufacturing. Until Ranbaxy and other Indian drug makers can address their ongoing quality control problems, they will continue to suffer lost opportunities and lost revenues.