Glenmark Pharmaceuticals Limited on Tuesday said the U.S. Food and Drug Administration has issued a Form 483 with six observations following a good manufacturing practices (GMP) inspection at its Goa facility, while noting that none of the findings relate to data integrity and are procedural in nature.
The inspection was conducted between June 22 and June 30, 2026, the Mumbai-based drugmaker said in a stock exchange filing. Glenmark added that none of the observations are repeat in nature and 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 U.S. FDA within the stipulated timeline,” Glenmark said, adding that it would keep the exchanges informed of any further developments.
