Category: Approval/Launch Region: Asia Company: Lupin Ltd

Lupin gets US FDA approval for doxycycline hyclate delayed-release tablets USP

Lupin gets US FDA approval for doxycycline hyclate delayed-release tablets USP

Global pharma major Lupin Limited announced that it has received approval from the United States Food and Drug Administration (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, to market 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.
 
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 US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

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