Ranbaxy gets US FDA’s approval for Fenofibrate Capsules

05 Nov 2014 Evaluate

Ranbaxy Laboratories has received approval from the U.S. Food and Drug Administration (US FDA) to manufacture and market Fenofibrate Capsules USP, 43 mg and 130 mg. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Antara Capsules, 43 and 130 mg, respectively, of Lupin Atlantis (Lupin).

Total annual market sales for Fenofibrate Capsules USP, 43 mg and 130 mg were $56 million in September 2014. Fenofibrate Capsules are indicated for Primary Hypercholesterolemia and Mixed Dyslipidemia. In addition, it is indicated for Severe Hypertriglyceridemia.

Ranbaxy Laboratories is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies.

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Company Name CMP
Sun Pharma Inds. 1534.70
Dr. Reddys Lab 5829.40
Cipla 1404.55
Zydus Lifesciences 1104.45
Lupin 1659.05
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