Lupin’s arm gets nod for its Ranolazine Extended from US FDA

01 Aug 2013 Evaluate

Pharma Major Lupin’s U.S. subsidiary- Lupin Pharmaceuticals, Inc. (LPI) has received final approval for its Ranolazine Extended release tablets, 500 mg and 1,000 mg from the United States Food and Drugs Administration (FDA). Ranolazine Extended release tablets are indicated for treatment of Chronic angina.

Lupin’s Ranolazine Extended release tablets are the AB rated generic equivalent of Gilead Sciences Ranexa Extended release tablets 500 mg and 1,000 mg strengths. Ranexa tablets 500 mg and 1,000 mg had U.S sales of approximately $443.4 million, for the twelve months ending March, 2013 (IMS Health data).

Lupin is the 5th largest and fastest growing generics player in the US (5.1% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales. The company is also the fastest growing top 10 generic pharmaceutical players in Japan and South Africa (IMS).

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2084.45 29.40 (1.43%)
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