Granules India Gets One USFDA Observation For Hyderabad API Plant

Granules India Ltd. on Friday said the US Food and Drug Administration issued a Form 483 with one observation after inspecting its Unit-I active pharmaceutical ingredient facility in Hyderabad, Telangana. The inspection was conducted from Monday to Friday, the company said in an exchange filing.

Granules India said it will respond to the observation within the stipulated timeline and is committed to addressing it promptly.
The facility is one of the world’s largest single-site paracetamol API plants by volume. It also houses manufacturing units for metformin and guaifenesin APIs, the company added.