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The Indian drugmaker will not resume production until it finds out why glass particles ended up in its pills earlier this month, the FDA said.
The US Food and Drug Admin. announced today that Ranbaxy Laboratories Ltd., India’s biggest drug-maker, has halted production of its generic version of the cholesterol-lowing drug Lipitor, the Associated Press reported.
The company supplied 43 percent of prescriptions for the generic, known as atorvastatin, in October, according to the New York Times.
The FDA said the company would not resume production until it determined what caused glass particles to end up in drugs that were distributed to the public earlier this month, the AP reported. After the glass particles were discovered earlier this month, Ranbaxy recalled 41 lots of 10-, 20- and 40-milligram doses of atorvastatin calcium tablets.
More from Global Post: Ranbaxy recalls some generic Lipitor
The situation is drawing attention to different standards that are applied to foreign drug-makers and US manufacturers, the New York Times reported. Studies have shown that while the FDA inspects domestic drug-makers once every two years, it visits generic manufacturing plants abroad only about once every seven to 13 years.
“I have pretty good faith in companies and plants that make drugs in this country because I know from my own experience that they try to do a good job,” Prabir K. Basu, executive director of the National Institute for Pharmaceutical Technology and Education, told the New York Times. “But my confidence is not that high when we are getting products from outside the country.”
According to the New York Times:
A law passed over the summer will eventually require the FDA to apply the same standards when inspecting all manufacturing plants, regardless of which country they’re in.