Lupin announced it has received the Establishment Inspection Report (EIR) from the U.S. FDA for its Pithampur Unit-3 facility after inspection between July 7 and July 17, 2025. The facility manufactures products like metered dose inhalers, dry powder inhalers, topical formulations, and nasal solutions. This signifies Lupin’s commitment to high manufacturing standards.
FDA Approval Received
Lupin has been granted the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for their Pithampur Unit-3 manufacturing facility. This follows an inspection that took place from July 7 to July 17, 2025. The announcement confirms the facility’s compliance with stringent quality standards.
Facility Details
The Pithampur Unit-3 facility is responsible for manufacturing a variety of pharmaceutical products, including metered dose inhalers, dry powder inhalers, topical formulations, and nasal solutions. The EIR confirms that these products are manufactured in accordance with U.S. FDA standards.
Company Statement
Nilesh Gupta, Managing Director of Lupin, stated that the receipt of the EIR demonstrates the company’s commitment to maintaining the highest standards of compliance and quality. The company aims to deliver high-quality, affordable medicines from world-class factories.
Source: BSE
