- Lupin has received an Establishment Inspection Report (EIR) from the U.S. FDA for its Pithampur Unit-3 manufacturing facility.
- The inspection was conducted from 7 to 17 July 2025 and covered products including inhalers, topical formulations, and nasal solutions.
Lupin Limited has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for its Pithampur Unit-3 facility in India. The report follows an inspection conducted between 7 and 17 July 2025.
The Pithampur Unit-3 site manufactures a range of products, including metered dose inhalers, dry powder inhalers, topical formulations, and nasal solutions. The receipt of the EIR indicates that the facility has addressed all regulatory requirements from the inspection.
“We are pleased to have received the EIR from the U.S. FDA for our Pithampur Unit-3 facility. This demonstrates our commitment to maintaining the highest standards of compliance and quality, as we aim to deliver high-quality, affordable medicines from world-class factories for patients worldwide.”
Nilesh Gupta, Managing Director of Lupin
