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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CNBC TV1816-12-2025, 23:30

Lupin's Nagpur Facility Gets US FDA VAI Classification for Injectables

  • Lupin's Nagpur injectable facility received a Voluntary Action Indicated (VAI) classification from the US FDA.
  • The Establishment Inspection Report (EIR) followed an inspection conducted from September 8 to September 16, 2025.
  • VAI classification means violations were found but do not warrant further regulatory action, allowing continued drug sales and new approvals.
  • Nilesh Gupta, MD, Lupin, affirmed the company's commitment to high quality and compliance standards.
  • Lupin shares closed down 0.32% on the BSE after the announcement.

Why It Matters: Lupin's Nagpur injectable facility secured a VAI classification from US FDA, ensuring continued operations.

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