Global pharma major Lupin Limited (Lupin) announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its manufacturing facility located in Ankleshwar, Gujarat, India.
The issuance of the EIR signals the successful closure of a product-specific Pre-Approval Inspection (PAI) conducted by the US regulatory authority at the site from March 2 to March 7, 2026.
Commenting on the development, Nilesh Gupta, Managing Director, Lupin, said:
“We are pleased to receive the EIR from the US FDA for our Ankleshwar facility. This outcome reflects our continued focus on quality excellence and regulatory compliance, reinforcing our commitment to delivering safe and effective medicines to patients worldwide.”
The successful inspection outcome underscores Lupin’sadherence to global manufacturing standards and clears a critical regulatory pathway for upcoming product launches from the Ankleshwar site to the U.S. market.
Written by Pragna Biswas
Graphics by Pramit Hazra
