Ranbaxy Receives Approval from USFDA for Generic Lipitor
New Delhi: The U.S health regulator granted approval to Ranbaxy Laboratories to produce generic version of cholesterol lowering drug Lipitor, a move that will help the India-based firm to launch the drug in the American market.
"Ranbaxy Laboratories has gained approval to make generic atorvastatin calcium tablets in 10 milligram, 20 mg, 40 mg, and 80 mg strengths. The drug will be manufactured by Ohm Laboratories in New Brunswick, NJ," U.S Food and Drug Administration (USFDA) said in a statement.
It was, however, not clear whether the USFDA had resolved pending issue of manufacturing norm violation by some of the company's plants in India. When contacted, Ranbaxy officials declined to comment on the development.