US FDA disallows Ranbaxy's Indian-manufactured generic Lipitor in US
05 Mar 2013
Ranbaxy Laboratories received a blow after the US regulator allowed it to manufacture its generic version of cholesterol-lowering drug Lipitor for the US market only from its Ohm Labs facility in the US and not from its lower-cost Indian plant.
The company is still awaiting approval from the US Food and Drug Administration (FDA) to resume manufacturing the formulation for its generic version of Lipitor at its Mohali facility in India, two senior executives aware of the development told The Economic Times.
This will affect Ranbaxy's bottomline since it will not be able to offer the drug at a cheaper price in the US compared to its rivals such as Dr Reddy's, which ships the drug from India or deal in large volumes, said the report.
Late last month, Ranbaxy announced that it will restart production of Atorvastatin, the generic name for Pfizer's blockbuster drug Lipitor, for supply to the US market, three months after recalling the drug after it found small glass particles in some lots of the drug. (See: Ranbaxy to restart production of generic version of cholesterol-lowering drug Lipitor)
The recall was only for a select lot of Atorvastatin of 10mg, 20mg, and 40mg dosage strengths, packaged in 90s and 500 count bottles. The recall did not affect the 80mg strength dosage.
The recall was only for the US market and not other markets across the world.
