USFDA issues EIR for Lupin Somerset facility

Mumbai: Global pharma major Lupin Limited has announced that the United States Food and Drug Administration (U.S. FDA) has issued the Establishment Inspection Report (EIR) for its manufacturing facility in Somerset, New Jersey, for the inspection conducted from January 27 to January 31, 2025.

“We are very pleased to have received the EIR for our Somerset facility. This milestone underscores our commitment to upholding the highest standards of quality and compliance, solidifying our position as a leading pharmaceutical manufacturer,” said Nilesh Gupta, Managing Director, Lupin.

Medical Dialogues team had earlier reported that the Company had received approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Ipratropium Bromide Nasal Solution (Nasal Spray), 0.03% (21 mcg/spray), to market a generic equivalent of Atrovent Nasal Spray, 0.03%, of BoehringerIngelheim Pharmaceuticals, Inc.

Read also: USFDA completes inspection of Lupin Somerset facility with no observations

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company has a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 23,000 professionals. 

Read also: Lupin bags USFDA nod for Ipratropium Bromide Nasal Solution for rhinorrhea