Pharma major Lupin Limited announced today that it has received approval for its Colesevelam Hydrochloride Tablets, 625 mg, from the United States Food and Drug Administration, to market a generic equivalent of Welchol Tablets, 625 mg, of Daiichi Sankyo, Inc.

Colesevelam Hydrochloride Tablets, 625 mg, are indicated as an adjunct to diet and exercise to:

Reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH).

Colesevelam Hydrochloride Tablets (RLD: Welchol) had an annual sales of approximately USD 159 million in the U.S. 

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.

The Company enjoys leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women’s health areas. Lupin is the 3rd largest pharmaceutical company in the U.S. by prescriptions and 5th in India by global revenues. The Company invests 9.6 % of its revenues on research and development.

The pharma company has fifteen manufacturing sites, seven research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.