Granules India has informed that the US FDA has completed a Pre-Approval Inspection (PAI) for a first to file controlled substance ANDA at the facility of Granules Pharmaceuticals, Inc., a wholly-owned foreign subsidiary of the Company located in Chantilly, Virginia, USA from 23rd June 2025 to 27th June 2025 with one (1) 483 observation. Granules Pharmaceuticals, Inc. addressed and resolved the observation during the inspection.
The above information is a part of company’s filings submitted to BSE.
