Global pharma major Lupin Limited (Lupin) on Tuesday announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA), Dolutegravir Tablets for Oral Suspension, 5 mg, to market a generic equivalent of Tivicay PD® Tablets for Oral Suspension, 5 mg of ViiV Healthcare Company, the company announced through an exchange filing.
This product will be manufactured at Lupin’s Nagpur facility in India.
Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD® ) had estimated annual sales of USD 1 million in the U.S.
About the company
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.
Lupin has 15 manufacturing sites, 7 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.
Lupin Shares
The shares of Lupin on Monday at 3:30pm IST were at Rs 892.50, up by 0.022 percent.
