Global pharmaceutical leader Lupin Limited announced today that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for its manufacturing facility in Dabhasa, Gujarat. The EIR follows the inspection conducted from April 8 to April 12, 2024, which concluded without any observations, resulting in a “No Action Indicated” (NAI) classification. This facility is part of Lupin Manufacturing Solutions (LMS), focusing on the development, manufacture, and sale of Active Pharmaceutical Ingredients (APIs) and Contract Development and Manufacturing Operations.
“We are pleased to receive the EIR for Dabhasa from the U.S. FDA,” said Nilesh Gupta, Managing Director, Lupin. “This achievement aligns with our unwavering commitment to maintaining the highest standards of quality and compliance across all our operations. It reaffirms our dedication to providing high-quality, affordable healthcare solutions to patients worldwide.”
Lupin is a transnational pharmaceutical company driven by innovation, headquartered in Mumbai, India. The company develops and commercializes a broad spectrum of branded and generic formulations, biotechnology products, and APIs in over 100 markets, including the U.S., India, South Africa, the Asia Pacific (APAC) region, Latin America (LATAM), Europe, and the Middle East.
Lupin holds a leadership position in the cardiovascular, anti-diabetic, and respiratory segments, with a strong presence in the anti-infective, gastrointestinal (GI), central nervous system (CNS), and women’s health areas. It is the third-largest pharmaceutical company in the U.S. by prescriptions. In FY24, the company invested 7.8% of its revenue in research and development.
Lupin operates 15 manufacturing sites and 7 research centers globally, with a workforce of over 20,000 professionals. It has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.
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