Ranbaxy Laboratories is back in the generic Lipitor saddle again. Three months after stopping production of the cholesterol fighter and recalling almost a half-million bottles, the Indian drugmaker says it is restarting production for the U.S. market.
Ranbaxy pulled 41 lots of the drug in late November after discovering glass particles in some pills. An internal investigation turned up a possible source--the broken glass lining of a drug-making reactor. The company now says it has been working with the FDA to fix the problem. "We ... have identified and implemented multiple corrective and preventative actions," Ranbaxy said in a statement (as quoted by Reuters).
Now, the company is aiming to get its atorvastatin product back into pharmacies. It has started making the drug's active ingredient, "as part of the first step in initiating the manufacturing process to resume supplies to the U.S. market," the company said.
Since the recall, Ranbaxy's share of the generic Lipitor market in the U.S. has plummeted to less than 3% from about 43%. The recall and production suspension didn't affect supplies for markets outside the U.S., the company says. Ranbaxy shares rose in New Delhi on the news of the production restart.
As The New York Times reports, some consumers have sued Ranbaxy, claiming they suffered various gastrointestinal problems after taking the company's generic pill. The company dismissed the complaints, and the FDA says it hasn't received any reports of adverse events related to the glass particles.
The Indian plant where Ranbaxy makes generic Lipitor has fallen short before. It is one of the facilities operating under an FDA consent decree. The agency had barred about 30 products from the U.S. after uncovering a string of manufacturing violations at Ranbaxy plants.
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