The FDA has started its inspection of a Ranbaxy Laboratories plant in India--a move that could help the generics maker resume supplies to the U.S. market after nearly three years under an import alert. The inspection comes as Ranbaxy remains in protracted negotiations with the FDA to resolve manufacturing violations at its plants in Dewas and Paonta Sahib, India.
The FDA inspection is taking place at a third facility, a finished-dosage plant in Mohali, India, the Economic Times reports. The inspection began a little over a week ago, sources tell the newspaper. "So far it appears to have gone well," one source said. "FDA has so far not found any major deficiency. But nothing can be said until the inspection concludes." The company itself refused comment.
If the plant passes FDA muster, it will be a badly needed boost for Ranbaxy at the agency. The company has as of yet been unable to work out a settlement of its manufacturing violations, meaning it still can't sell a host of its medications in the U.S. market. And the U.S. had accounted for about one-fourth of the company's $1.9 billion in annual sales, the Times points out.
Perhaps most importantly, however, is that Ranbaxy needs FDA clearance to launch its knockoff version of Pfizer's Lipitor, the best-selling drug in the world. So far, the agency hasn't approved the company's copycat Lipitor, and the presumed launch date--November of this year--is approaching quickly. Ranbaxy has 180-day exclusivity, so it would have the market to itself for six months after that--provided it can work out its FDA difficulties and get its version approved.
- read the story in the Times