Contamination shuts down generic drug maker

  • Article by: KATIE THOMAS
  • New York Times
  • November 29, 2012 - 8:00 PM

Ranbaxy Pharmaceuticals, the largest producer of the generic version of Lipitor, has halted all production of the cholesterol-lowering drug until it can figure out why glass particles may have ended up in pills that were distributed to the public, the Food and Drug Administration (FDA) announced on Thursday.

The FDA said it had not received any reports of patients being harmed by the particles, which are about the size of a grain of sand.

Earlier this month, Ranbaxy recalled more than 40 lots of the drug because of the glass contamination, but it said then that it was continuing to make the drug.

The contamination was the latest episode in a history of manufacturing lapses at Ranbaxy, which is a subsidiary of the Japanese pharmaceutical company Daiichi Sankyo. The company has been operating under a court-ordered consent decree since January, one that federal authorities have called "unprecedented in scope," after they identified a host of manufacturing problems at the company's plants in India and the United States and concluded that Ranbaxy had submitted false data in drug applications to the FDA. The decree prevents Ranbaxy from manufacturing drugs at its most troubled facilities until it can show it is meeting U.S. standards, although it was allowed to continue production at other plants.

Ranbaxy has held a significant share of the market for Lipitor, also known as atorvastatin, since it became the first company to sell a generic version of Lipitor after Pfizer lost patent protection for the top-selling drug in November last year. The FDA said it did not expect a shortage of atorvastatin.

The FDA advised consumers to check with their pharmacists if they believe they received a recalled drug.

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