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
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