Lupin’s Ankleshwar facility receives EIR from US FDA
The regulatory clearance follows a product-specific pre-approval inspection conducted by the US drug regulator in March 2026.
Global pharma major Lupin announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its Ankleshwar facility in Gujarat, India, following closure of a product- specific Pre-Approval Inspection from March 2 to March 7, 2026.
Nilesh Gupta, Managing Director, Lupin, stated, “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.”