USFDA Grants Satisfactory EIR to Lupin's Goa Facility

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Lupin's Goa Plant Receives Satisfactory EIR from USFDA

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News18•27-02-2026, 14:15

Lupin's Goa Plant Receives Satisfactory EIR from USFDA

•Drug maker Lupin announced it received an Establishment Inspection Report (EIR) from the USFDA for its Goa manufacturing facility.
•The EIR was issued with a satisfactory Voluntary Action Indicated (VAI) classification.
•The inspection of the facility by the USFDA took place from November 10-21, 2025.
•Lupin MD Nilesh Gupta stated this outcome reflects their focus on quality excellence and regulatory compliance.
•The company's shares were trading 0.24 percent up on BSE following the announcement.

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Lupin said the US drug regulator has classified its inspection of the Pithampur Unit 2 manufacturing facility as 'official action indicated' (OAI).

The US Food and Drug Administration (USFDA) had conducted inspections at the facility from July 8 to July 17, 2025, and closed it by issuing Form 483 with four observations.

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