Lupin's Aurangabad facility earns U.S. FDA approval

Mumbai: Lupin Limited (Lupin), a global pharmaceutical company based in Mumbai, announced today that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for its Aurangabad manufacturing facility. The inspection was conducted between March 6 and March 15, 2024, and the U.S. FDA classified the facility's inspection as Voluntary Action Indicated (VAI).

Nilesh Gupta, Managing Director of Lupin, expressed satisfaction with the receipt of the EIR with VAI status from the U.S. FDA following the recent inspection of the Aurangabad facility. He emphasized the company's commitment to maintaining high compliance standards and delivering quality healthcare solutions globally.

Lupin, headquartered in Mumbai, India, is an innovation-driven pharmaceutical company operating in over 100 markets worldwide, including the U.S., India, South Africa, Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East. The company specializes in branded and generic formulations, biotechnology products, and APIs.

Lupin holds leadership positions in cardiovascular, anti-diabetic, and respiratory segments and maintains a notable presence in anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. In the U.S., Lupin ranks as the third-largest pharmaceutical company by prescriptions. Additionally, the company allocated 7.9% of its revenue to research and development in FY23.

With 15 manufacturing sites, 7 research centers, and a global workforce exceeding 20,000 professionals, Lupin has consistently earned recognition as a 'Great Place to Work' in the Biotechnology & Pharmaceuticals sector.