(Reuters) - Indian generic drugmaker Ranbaxy Laboratories Ltd said on Friday it will resume production of its version of Pfizer’s cholesterol fighter Lipitor for sale in the United States after resolving the issues that led to a November recall.
Ranbaxy in November recalled its atorvastatin from the U.S. market and stopped manufacturing the widely used cholesterol lowering medicine after the company discovered contamination with tiny glass particles in certain lots of 10 milligram, 20 mg and 40 mg doses of the drug. Atorvastatin is the generic name for Lipitor.
“We are working with the U.S. FDA, and have identified and implemented multiple corrective and preventative actions,” Ranbaxy spokesman Chuck Capriello said in an e-mailed statement.
“As part of the first step in initiating the manufacturing process to resume supplies to the U.S. market, we have commenced the production of the drug substance for our atorvastatin product,” he added.
The recall and production halt did not affect Ranbaxy’s atorvastatin supply for markets outside the United States, the company said.
During its first six months on the market, atorvastatin generated sales of nearly $600 million for Ranbaxy, according to industry analyst estimates.
Prior to expiration of Pfizer’s patent, Lipitor was the world’s top selling prescription medicine with annual peak sales of about $13 billion for the largest U.S. drugmaker.
Ranbaxy has been operating under heightened scrutiny to ensure it meets good manufacturing practices following a series of manufacturing problems that nearly derailed it ability to sell atorvastatin in the United States.
In 2008, the FDA banned the company from importing about 30 drugs after it found manufacturing deficiencies at two of the company’s facilities in India, and Ranbaxy was later accused of falsifying data used in its drug applications.
Ranbaxy said on Friday that it was confident in the continuing safety and quality of its products.
Reporting by Bill Berkrot;editing by Sofina Mirza-Reid