USFDA concludes inspection of Lupin Dabhasa facility with no observations
Mumbai: Global pharma major Lupin Limited has announced that the
United States Food and Drug Administration (U.S. FDA) has completed a GMP Inspection of its API
manufacturing facility located at Dabhasa, India.
The inspection was conducted from April 8 to April
12, 2024 and concluded with no observations.
“We are pleased to announce the successful completion of the U.S. FDA inspection of our Dabhasa
facility,” said Nilesh Gupta, Managing Director, Lupin. “This accomplishment underscores our
unwavering dedication to maintaining the highest standards of quality and compliance in all aspects of
our operations. This reaffirms our pursuit of excellence in delivering high-quality, affordable healthcare
for all.”
Read also: Lupin names Dr Ranjana Pathak as Chief Quality Officer
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 7.9% of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers.
Read also: Lupin unveils first generic version of Oracea in US
