Feb 22 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
"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
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.