Lupin Gets US FDA Nod for Nagpur Injectable Facility, Marking Major Compliance Milestone

Updated: December 17, 2025 00:40

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Lupin has received a US FDA Establishment Inspection Report (EIR) for its Nagpur injectable facility with a “Voluntary Action Indicated” classification. The inspection outcome confirms compliance with U.S. manufacturing standards, reinforcing Lupin’s quality credentials and marking a positive step for its injectables business and U.S. market presence.

Lupin Limited, one of India’s leading pharmaceutical companies, has announced a key regulatory development — the receipt of an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (US FDA) for its injectable manufacturing facility in Nagpur. The facility has been classified as “Voluntary Action Indicated” (VAI), meaning the inspection found no major compliance issues requiring further regulatory action.

The inspection was conducted between September 8 and September 16, 2025, and the subsequent EIR signals that the site meets the required U.S. manufacturing standards. This is a positive outcome for Lupin as it strengthens the company’s compliance record and reinforces its position in the U.S. generics and injectables market.

Nilesh Gupta, Managing Director, Lupin, lauded the team’s efforts,ùùù saying the company remains committed to maintaining “the highest standards of quality and compliance across facilities.” He added that Lupin continues to enhance its quality systems and operational excellence to meet global benchmarks.

Notable Updates

EIR Received: Lupin’s Nagpur injectable unit successfully clears the U.S. FDA inspection with a VAI status.
Significance: A VAI classification indicates minor observations that do not warrant regulatory restrictions — a positive sign for future product approvals and exports.
Inspection Timeline: Conducted from September 8–16, 2025, with the EIR issued later in December.
Strategic Importance: The Nagpur site plays a key role in Lupin’s injectables portfolio, supporting both domestic and U.S. supply chains.
Management Comment: Nilesh Gupta emphasized ongoing investment in quality systems and manufacturing excellence.

This clearance follows several successful inspections across Lupin’s global manufacturing network, underscoring its strong compliance track record and growing focus on complex generics and injectables.

Sources: Lupin Limited corporate announcement, company website.

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