Ranbaxy Receives Approval From FDA to Market Fenofibrate Capsules USP, 43 Mg And 130 Mg
Princeton, NJ – November 5, 2014 -- Ranbaxy Laboratories Limited (RLL) announced today that the Company has received approval from the U.S. Food and Drug Administration 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 (IMS - MAT: September 2014). Fenofibrate Capsules are indicated for Primary Hypercholesterolemia and Mixed Dyslipidemia. In addition, it is indicated for Severe Hypertriglyceridemia.
"We are pleased to receive approval for these two strengths of Fenofibrate Capsules, which represents a welcome addition to our generic portfolio 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 U.S. facility located in New Brunswick, New Jersey and launched immediately thereafter," according to Dan Schober, Vice President, Trade Sales.
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.
Ranbaxy Laboratories Limited (RLL) 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. Ranbaxy's continued focus on R&D has resulted in several approvals, in developed and emerging markets many of which incorporate proprietary Novel Drug Delivery Systems (NDDS) and technologies, developed at its own labs. The company has further strengthened its focus on generics research and is increasingly working on more complex and specialty areas. Ranbaxy serves its customers in over 150 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 43 countries and manufacturing operations in 8 countries. Ranbaxy is a member of the Daiichi Sankyo Group. Through strategic in-licensing opportunities and its hybrid business model with Daiichi Sankyo, a leading global pharma innovator headquartered in Tokyo, Japan, Ranbaxy is introducing many innovator products in markets around the world, where it has a strong presence. This is in line with the company's commitment to increase penetration and improve access to medicines, across the globe. For more information, please visit www.ranbaxy.com.
*Antara® is a registered trademark of Lupin Atlantis