Lupin bags USFDA nod for Doxycycline Hyclate Delayed Release Tablets
Mumbai: Global pharma major Lupin Limited today announced that the company has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Doxycycline Hyclate Delayed-Release Tablets USP, 50 mg, 60 mg, 75 mg, 80 mg, 100 mg, 120 mg, 150 mg, and 200 mg.
The product is a generic equivalent of Doryx Delayed-Release Tablets, 50 mg, 75 mg, 80 mg, 100 mg, 150 mg, and 200 mg and Doryx MPC Delayed-Release Tablets, 60 mg and 120 mg, of Mayne Pharma International Pty. Ltd.
This product will be manufactured at Lupin’s Pithampur facility in India.
Doxycycline Hyclate Delayed-Release Tablets USP (RLD Doryx) had estimated annual sales of USD 9 million in the U.S. (IQVIA MAT June 2023).
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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 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. The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centers.
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