Natco Gets US FDA Nod for API Unit

  Published 10 months ago

Natco Pharma received a US FDA EIR for its Mekaguda API unit after a June inspection with a single VAI observation.

  • Inspection occurred from June 9–13, 2025; only one observation was noted, categorized as voluntary action indicated (VAI).
  • Regulatory filing confirms receipt of Establishment Inspection Report (EIR), indicating closure of inspection process.
  • Natco develops APIs, generics, specialty drugs, and crop protection products from its Hyderabad-based headquarters.

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