Lupin gets USFDA EIR for Dabhasa facility
Mumbai: Global pharma major Lupin Limited has announced that the Company has
received the Establishment Inspection Report (EIR) from the United States Food and Drug
Administration (U.S. FDA) for its manufacturing facility located in Dabhasa, Gujarat.
The EIR was issued
post the last inspection of the facility conducted from April 8 to April 12, 2024.
The inspection
concluded with no observations and the facility receiving an inspection classification of “No Action
Indicated” (NAI).
The facility is a part of Lupin Manufacturing Solutions (LMS), which is engaged in the
development, manufacture and sale of Active Pharmaceutical Ingredients and Contract Development
and Manufacturing Operations.
Read also: Lupin bags USFDA tentative nod for Olopatadine Hydrochloride Ophthalmic Solution(OTC)
“We are pleased to receive the EIR for Dabhasa from the U.S. FDA,” said Nilesh Gupta, Managing
Director, Lupin. “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. This
reaffirms our pursuit of delivering high-quality, affordable healthcare solutions to our patients
globally.”
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.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has
a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s
health areas. The company
invested 7.8% of its revenue in research and development in FY24.
Lupin has 15 manufacturing sites, 7 research centers.
