Ranbaxy resumes production of cholesterol drug ingredients
NEW YORK — Drug maker Ranbaxy Labs has started producing the ingredients for a cholesterol drug while working with the Food and Drug Administration to fix manufacturing issues that led to the recall in November 2012 of several batches of the drug.
The Indian drug maker said it had initiated corrective and preventive actions, or CAPA, as it prepared to resume supplies of generic atorvastatin calcium tablets to the U.S. market. The drug is a generic version of Pfizer's Lipitor, and Ranbaxy became the first company to market a generic version in November 2011.
The company voluntarily recalled more than three dozen lots of the drug in November 2012, including 500-pill bottles of the drug in the 10-mg, 20-mg and 40-mg strengths, though the recall did not affect the drug in the 80-mg strength. The recall was due to the possible presence of small glass particles in the drug, the company said.