Gland Pharma FDA Inspection 2025 Update

  Published 1 year ago

USFDA inspected Gland Pharma's Visakhapatnam facility (19, 25 Feb 2025), issuing three procedural Form 483s unrelated to data integrity; CAPA submission planned.

  • Gland Pharma operates globally in 60 countries with diverse injectable products.
  • The company pioneered heparin technology in India, expanding its pharmaceutical footprint.
  • Observations are non-repeated; CAPA to be submitted within the stipulated timeline as required by the USFDA.

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