StockWatch
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Pharmaceuticals
USFDA21 Aug 2026, 05:31 pm

Natco Pharma: US FDA Inspection Concluded at Visakhapatnam FDF Unit

AI Summary

Natco Pharma Limited announced the conclusion of a U.S. Food and Drug Administration (FDA) inspection at its Finished Dosage Formulations (FDF) manufacturing plant in Parawada, Visakhapatnam, Andhra Pradesh. The inspection took place from August 17th to August 21st, 2026. Following the inspection, the company received a Form 483 with four observations. Natco Pharma believes these observations are procedural and is confident in addressing them within the stipulated timelines. The company's manufacturing facilities are approved by various global regulatory authorities, and it caters to over 50 global markets.

Key Highlights

  • US FDA inspection concluded at Visakhapatnam FDF unit.
  • Company received a Form 483 with 4 procedural observations.
  • Natco Pharma is confident in addressing observations within timelines.
  • Facility is approved by multiple global regulatory authorities.