Ranbaxy Laboratories Ltd. announced that it has received the approval from the US FDA to manufacture and market Fenofibrate Capsules USP, 43 mg and 130 mg.
The Office of Generic Drugs, US FDA, has determined the Ranbaxy formulations to be bio-equivalent and have the same therapeutic effect as that of the reference listed drug Antara Capsules, 43 mg and 130 mg, respectively, of Lupin Atlantis.
Fenofibrate Capsules are indicated for Primary Hypercholesterolemia and Mixed Dyslipidemia. In addition, it is indicated for Severe Hypertriglyceridemia.
As per IMS MAT September 2014 data, total annual market sales of Fenofibrate Capsules USP, 43 mg and 130 mg, were $56 million.
Ranbaxy Inc.'s Vice President-Trade Sales Dan Schober said, "We are leased to receive approval for these two strengths of products and offer an alternative in strengths and dosage forms for this molecule to patients and healthcare professionals. The product will be manufactured at Ohm Laboratories, in our US facility located in New Brunswick, New Jersey, and launched immediately."
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a wholly-owned subsidiary of Ranbaxy Laboratories Ltd., India's largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.
At the BSE, Ranbaxy Laboratories shares are currently trading at Rs.63.80, up 1.97 percent from the previous close.
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