The United States Food & Drug Administration (USFDA) has completed a GMP inspection at Glenmark Pharmaceuticals’ manufacturing facility situated in Goa from June 22, 2026 to June 30, 2026.
At the end of the inspection, the company was issued a Form 483 with six observations. There was no observation related to data integrity reported. These observations are procedural in nature, and none are repeat observations.
The company does not anticipate any impact on the supply of its commercial products. The company will work in close collaboration with the Agency to address the observations and will respond to the USFDA within the stipulated timeline.
Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.
