Mumbai, Baltimore: Pharma major Lupin Limited (Lupin) announced that it has received approval for its Trientine Hydrochloride Capsules USP, 250 mg, from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of Syprine® Capsules, 250 mg, of Bausch Health US, LLC. The product would be manufactured at Lupin’s Nagpur (Unit 1) facility, India.

Trientine Hydrochloride Capsules USP, 250 mg, are indicated in the treatment of patients with Wilson’s disease who are intolerant of penicillamine.

Trientine Hydrochloride Capsules USP (RLD: Syprine®) had an annual sales of approximately USD 86 million in the U.S. (IQVIA MAT March 2020).

About Lupin

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. 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 third largest pharmaceutical company in the U.S. by prescriptions and in India by global revenues. The Company invests 9.6 % of its revenues on research and development.

Lupin 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.

Please visit www.lupin.com for more information.

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*Safe Harbor Statement

Syprine® is a registered trademark of Bausch Health Ireland Limited.