Lupin gets USFDA nod for Trientine Hydrochloride Capsules

Mumbai, Baltimore: Drug Maker Lupin Limited has received approval for Trientine Hydrochloride Capsules USP, 250 mg, from the United States Food and Drug Administration (USFDA), 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.

Lupin Limited is a global pharmaceutical company based in Mumbai, Maharashtra, 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 the Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.

The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women's health areas.

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