Lupin gets USFDA nod for generic equivalent of Depen Tablets
Mumbai, Baltimore: Pharma major, Lupin Limited, announced that the company has received approval for its Penicillamine Tablets USP, 250 mg, from the United States Food and Drug Administration (USFDA), to market a generic equivalent of Depen Tablets, 250 mg, of Mylan Specialty, L.P.
The product would be manufactured at Lupin's Nagpur facility and is expected to be launched shortly.
Penicillamine Tablets USP, 250 mg, are indicated in the treatment of Wilson's disease, Cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy.
Penicillamine Tablets USP (RLD: Depen) had an annual sales of approximately USD 4 million in the U.S. (IQVIA MAT September 2020).
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.
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