Ranbaxy shuts U.S. plant targeted by FDA

Ranbaxy Laboratories has decided to cut its losses at its plant in Gloversville, NY. Lambasted by the FDA for lapsing on quality control and manufacturing unapproved drugs, the plant is in the process of shutting down, with all operations scheduled to stop by Oct. 1. It had not turned out a product for the commercial market since March 2010, the Economic Times reports. 

In something of an understatement, Ranbaxy Managing Director Arun Sawhney told the Times the Gloversville plant had been operating at a "sub-optimal level." Given that it wasn't producing drugs for sale, shutting it down won't affect the company's revenues. Focused on liquid formulations, the plant was run by U.S. subsidiary Ohm Laboratories.

The Gloversville plant isn't the only Ranbaxy facility to draw warnings from the FDA. The company is still trying to negotiate its way out of an import ban imposed by the agency two years ago. The agency has been investigating Ranbaxy for substandard manufacturing and falsified reports, and two plants in India remain on the FDA's hit list.

Along with last week's earnings report, Ranbaxy announced that it was making progress with the FDA--"Negotiations with the regulators are progressing well"--but obviously, it has no deal yet. Its regulatory problems are thorny enough to threaten the launch of its generic version of Pfizer's Lipitor, a drug expected to be a massive revenue driver for Ranbaxy. There's no settlement on that yet, either; "We remain optimistic," Sawhney said last week.

- see the release from Ranbaxy
- get more from the Economic Times

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