Global pharmaceutical giant Lupin Limited has announced that its Somerset, New Jersey manufacturing facility has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA). The inspection, conducted from January 27 to January 31, 2025, confirms Lupin’s adherence to stringent regulatory standards.
Expressing his satisfaction, Nilesh Gupta, Managing Director of Lupin, stated, “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.”
In the meantime, on February 10, the company received U.S. FDA approval for its Ipratropium Bromide Nasal Solution (0.03%), a generic equivalent of Atrovent® Nasal Spray by Boehringer Ingelheim. This approval allows Lupin to expand its presence in the U.S. pharmaceutical market by offering an affordable alternative for patients with perennial rhinitis.
Manufactured at Lupin’s Pithampur facility in India, this nasal spray is indicated for symptomatic relief of rhinorrhea (runny nose) in adults and children aged six and older. With Atrovent® Nasal Spray generating approximately $22 million in annual U.S. sales (IQVIA MAT December 2024), Lupin’s entry into this market enhances patient access to cost-effective treatments.
