Look for Drugs and Conditions

Representative Image

Lupin Receives Tentative Approval from the U.S. FDA for a New Drug

Global pharma major Lupin Limited announced recently that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Empagliflozin, Linagliptin, and Metformin Hydrochloride Extended-Release Tablets. This approval allows Lupin to market a generic equivalent of Trijardy XR Extended-Release Tablets, produced by Boehringer Ingelheim Pharmaceuticals, Inc. Lupin's Pithampur facility in India will manufacture the product.

Empagliflozin, Linagliptin, and Metformin Hydrochloride Extended-Release (ER) Tablets, also known as Trijardy XR, had an estimated annual sale of $111 million in the U.S. as of April 2024, according to IQVIA.

Lupin is a Mumbai-based pharmaceutical company that develops and commercialises branded and generic formulations, biotechnology products, and APIs. It operates in over 100 markets, including the U.S., India, South Africa, and the Asia Pacific, Latin America, Europe, and Middle East regions. Lupin holds leadership positions in the cardiovascular, anti-diabetic, and respiratory segments and a significant presence in the anti-infective, gastrointestinal, central nervous system, and women's health areas. It is the third-largest pharmaceutical company in the United States regarding prescriptions.

The company invested 7.8% of its revenue in research and development in FY24. With 15 manufacturing sites, 7 research centres, and over 20,000 professionals worldwide, Lupin consistently earns recognition as a 'Great Place to Work' in the biotechnology and pharmaceuticals sector.

Be first to post your comments

Post your comment

Related Articles

Ad 5