Lupin Limited secures major victory: A perfect FDA score for its Gujarat plant

Lupin Limited (Lupin), a global pharmaceutical powerhouse, has been awarded the Establishment Inspection Report (EIR) by the United States Food and Drug Administration (U.S. FDA). The EIR pertains to Lupin’s manufacturing facility located in Dabhasa, Gujarat, following an inspection that took place from April 8 to April 12, 2024. This rigorous inspection concluded without any observations, earning the facility a coveted “No Action Indicated” (NAI) classification. This status reaffirms the facility’s adherence to the highest operational standards required by regulatory authorities.

The Dabhasa facility is an integral part of Lupin Manufacturing Solutions (LMS), which focuses on the development, manufacture, and sale of Active Pharmaceutical Ingredients (APIs) and engages in Contract Development and Manufacturing Operations (CDMO). Nilesh Gupta, Managing Director at Lupin, expressed his satisfaction with this achievement, stating, “We are pleased to receive the EIR for Dabhasa from the U.S. FDA. This achievement is in line with our continued focus and commitment to maintaining the highest standards of quality and compliance in all aspects of our operations.”

Lupin is an innovation-driven transnational pharmaceutical company headquartered in Mumbai, India. The company excels in developing and commercializing a vast array of branded and generic formulations, biotechnology products, and APIs. Lupin’s market reach spans over 100 countries across various regions including the U.S., India, South Africa, the Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East.

The company holds a leadership position in the cardiovascular, anti-diabetic, and respiratory segments, and maintains a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. Remarkably, Lupin is ranked as the third-largest pharmaceutical company in the U.S. by prescriptions. In FY24, Lupin invested 7.8% of its revenue in research and development, underscoring its commitment to innovation.

With 15 manufacturing sites and 7 research centers worldwide, Lupin employs over 20,000 professionals. The company has been consistently acknowledged as a ‘Great Place to Work’ within the Biotechnology & Pharmaceuticals sector, highlighting its dedication to creating a supportive and innovative work environment.

This recent regulatory nod from the U.S. FDA not only enhances Lupin’s compliance credentials but also strengthens its global supply chain capabilities, enabling it to deliver high-quality, affordable healthcare solutions globally.