Lupin Receives USFDA EIR for Ankleshwar Facility Following Pre-Approval Inspection
New Delhi: Global pharmaceutical major Lupin Limited has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its manufacturing facility in Ankleshwar, Gujarat.
The EIR follows the successful closure of a product-specific Pre-Approval Inspection (PAI) conducted by the USFDA at the facility from March 2 to March 7, 2026.
Commenting on the development, Lupin Managing Director Nilesh Gupta 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 receipt of an EIR signifies the conclusion of the inspection process and reflects the regulator's assessment of the facility following the inspection.
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Lupin is a global pharmaceutical company headquartered in Mumbai, with a presence in more than 100 markets worldwide. The company operates across branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients (APIs).
The company has 15 manufacturing facilities and seven research centres globally and maintains a strong presence in key therapeutic segments including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health.
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