Ranbaxy Laboratories has stumbled again, only about 7 months after its return from FDA banishment from the U.S. market. And it has tripped up on the drug that powered it to a massive first quarter in the U.S., atorvastatin, generic Lipitor, a product with which it was leading the world in production.
The company says in a statement on its U.S. website that the affected product may contain particles of glass, of less than 1 mm. "Ranbaxy Pharmaceuticals Inc. is conducting a voluntary recall for atorvastatin calcium tablets, in connection with its 10 mg 20 mg and 40 mg dosage strengths, packaged in 90's and 500 count bottles and only with respect to certain select lot numbers. The recall does not affect or relate to the 80 mg strength."
The FDA tells Bloomberg the disruption may cause a shortage of generic Lipitor in the U.S. About 1 million prescriptions of the drug are sold each week. Mylan ($MYL) and Watson Pharmaceuticals ($WPI) also make the generic and may be able to pick up some of the slack, according to Bloomberg.
Ranbaxy only returned to importing products to the U.S. in April after the FDA approved its generic version of Lipitor being made at a plant in India that is operating under a consent decree. The Indian company had been embroiled in manufacturing problems since 2008, when FDA barred 30 products from the U.S. The agency not only found problems with its plants but also determined that the Indian company had faked some data it had sent to the agency. Late last year, Ranbaxy and Daiichi Sankyo, the Japanese company that owns controlling interest in Ranbaxy, entered into a 5-year agreement with the Department of Justice and FDA, agreeing to tighten oversight of its development and manufacturing operations from independent, outside consultants. It also forfeited the 180-day exclusivity it had for three unnamed products.
When the manufacturing allegations initially rolled in, so did doubt that the company could pull off a Lipitor-knockoff launch. Rival Mylan went as far as to sue FDA to negate Ranbaxy's 180-day exclusivity period, but Ranbaxy prevailed and the drug powered it to a huge first quarter in the U.S., with its sales doubling on the strength of atorvastatin. At least some of that will be forfeited now, analyst Nitin Agarwal with IDFC Securities in Mumbai tells Bloomberg. "There will be a financial loss linked to the recall. Supplies will be out of the market for the next two weeks and that should have an impact on their market share."