Glenmark Pharmaceuticals announced that the US Food and Drug Administration (US FDA) has successfully completed a pre-approval inspection of its formulations manufacturing facility in Chhatrapati Sambhajinagar (Aurangabad). The inspection, conducted from November 24–28, 2025, concluded with zero Form 483 observations, reflecting strong compliance standards at the site.

In a separate development, Glenmark has also received the Establishment Inspection Report (EIR) from the US FDA for its formulations facility in Monroe, North Carolina, which has been classified as Voluntary Action Indicated (VAI). The inspection at the Monroe plant took place from June 9–17, 2025. With the VAI status confirmed, the company will now resume commercial manufacturing operations at the site.

Glenmark Pharmaceuticals is a research-driven global pharmaceutical organisation with a presence across branded, generics, and OTC segments. The company focuses on therapeutic areas such as respiratory, dermatology and oncology, and has 11 advanced manufacturing facilities across four continents and operations in over 80 countries.