The United States Food and Drug Administration (USFDA) has completed a routine Good Manufacturing Practice (GMP) inspection at Gland Pharma’s VSEZ Sterile Oncology Formulations Facility and API Facility at Visakhapatnam. The inspection, conducted from August 24 to September 1, 2026, was concluded with ZERO Form 483 Observations.
Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.