Ranbaxy Laboratories Ltd., India’s biggest drugmaker, may forego at least $200 million in sales as a result of a proposed settlement with U.S. authorities over manufacturing violations, a Kotak Securities Ltd. analyst said.
A consent decree, signed between Ranbaxy and the (FDA) last month and filed in a US court on Wednesday, extends the ban on supply of drugs from four plants to the US market until the Indian drug maker resolves the problems at these facilities, dashing hopes of the embargo being lifted immediately after the settlement
Ranbaxy Laboratories has agreed to make significant changes in its manufacturing facilities in India and the US as part of a settlement that seeks to end wide-ranging investigations against the drug maker by the US regulatory authorities. The company agreed to hire an outside expert to conduct a thorough internal review at the affected facilities and to audit past drug applications, and hire an outside auditor for future applications, the US Justice Department said.
The company launched the first generic version of the cholesterol-lowering drug Lipitor in the United States on December 1. Lipitor is the biggest-selling drug of all time.
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