Lupin’s Somerset Facility Receives USFDA EIR

24 Feb 2025 , 09:19 AM

Lupin Ltd has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its manufacturing facility in Somerset, New Jersey.

The inspection covered the period from January 27 until January 31, 2025, and was used to assess cGMP and other regulatory requirements at the facility. USFDA issues an Establishment Inspection Report (EIR) after an inspection evaluating the facility for quality control, manufacturing and overall safety standards.

An EIR is a key milestone as it verifies that the manufacturing site is compliant with US regulations, which is necessary to continue approving the manufacturing of drugs and providing access to the US market.

“Being accepted into the PICS database is testimony of the plant demonstrating adherence to the highest standards of quality and compliance regime as mandated by the health authorities across the world,” said Nilesh Gupta, Managing Director, Lupin.

Lupin Ltd is an Indian multinational which operates in 149 countries and is among the top 10 pharmaceutical companies in the world comprising brands and generics, complex generics, biotechnology products and APIs.

With 15 manufacturing plants and seven research centers across the globe, the company continues to expand to meet the needs of its clientele while remaining compliant with strict regulatory guidelines. This achievement further bolsters Lupin’s portfolio as a world-class pharmaceutical manufacturer and strengthens its compliance credentials for the US Markets.