Lupin Bioresearch Center Passes U.S. FDA Inspection with Zero Observations
Filing Summary
Lupin Limited announced that its Bioresearch Center in Pune successfully completed an onsite clinical inspection by the U.S. FDA from November 3 to November 6, 2025, resulting in zero 483 observations. Additionally, a bio-analytical Remote Regulatory Assessment conducted from October 30 to November 7, 2025, also concluded with no observations. This update was disclosed in compliance with Regulation 30 of the SEBI Listing Obligations and Disclosure Requirements. Lupin is a global pharmaceutical leader with a focus on branded and generic formulations, biotechnology products, and active pharmaceutical ingredients.
Lupin Limited reported that the United States Food and Drug Administration (U.S. FDA) completed an onsite clinical inspection at its Bioresearch Center in Pune from November 3 to November 6, 2025. The inspection concluded with zero 483 observations. Additionally, a bio-analytical Remote Regulatory Assessment was conducted from October 30 to November 7, 2025, which also resulted in no observations.
The announcement was made in accordance with Regulation 30 of the Securities and Exchange Board of India (SEBI) Listing Obligations and Disclosure Requirements. The company emphasized the successful completion of these regulatory assessments, highlighting the compliance of its operations with U.S. FDA standards.
The inspection and assessment were part of routine regulatory procedures to ensure that the Bioresearch Center adheres to the required quality and compliance standards. The absence of observations indicates that the center met all necessary regulatory requirements during the inspection period.
Lupin Limited is a global pharmaceutical company specializing in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company operates in over 100 markets and maintains a strong presence in India and the U.S. across various therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health.
Lupin continues to focus on improving patient health outcomes through its subsidiaries, which include Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. The company operates 15 manufacturing sites and 7 research centers globally, supported by a workforce of over 24,000 professionals.