FDA Bars Ingredients From Ranbaxy's India Plant

The U.S. Food and Drug Administration took another action against Ranbaxy Laboratories Ltd. on Thursday, prohibiting it from making or selling drug ingredients from its Toansa, India, plant for the U.S. market.

Ranbaxy, an Indian unit of Japan's Daiichi Sankyo Co., has been a major supplier of drug ingredients to the U.S.--especially for generic drugs--but has come under FDA scrutiny of late.

The federal agency said Ranbaxy was blocked from distributing any drug raw materials in the U.S. from the Toansa facility. Ranbaxy also is blocked from making raw ingredients from Toansa available to other companies for sale in the U.S., the FDA said.

The FDA said it didn't immediately have a full list of drugs made at the plant. Ranbaxy officials weren't immediately available for comment.

The FDA action followed inspections of the Toansa plant by the U.S. agency between Jan. 5 and Jan. 11. The FDA said Ranbaxy staffers retested raw materials after they failed earlier tests "in order to produce acceptable findings," and that the staffers didn't investigate the failures.

Ranbaxy is a major supplier of raw materials for the generic drug market. The FDA said it didn't know of any immediate shortages that would be triggered by its action, but it said it "may modify" the order if a medically necessary drug is in short supply because of it.

In January 2012, Ranbaxy reached a consent decree with the U.S. Department of Justice over manufacturing quality issues. The decree required the company to take steps to ensure the integrity of production at three plants, at Paonta Sahib, Batamandi and Dewas, India, as well as at the company's unit in Gloversville, N.Y.

In September, the FDA also blocked imports from Ranbaxy's newest plant, at Mohali in northern India.

Ranbaxy has five manufacturing facilities in India that are registered with the FDA: Paonta Sahib, Mohali, Toansa, Gurgaon and Dewas. Gurgaon isn't currently producing drugs for the U.S. market. The other four facilities--Paonta Sahib, Mohali, Toansa and Dewas--are all now covered under the consent decree.

Write to Thomas M. Burton at [e-mail]

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