Granules Pharmaceuticals, a wholly-owned subsidiary of

in Virginia, USA, has received an Establishment Inspection Report (EIR) from the FDA. The Pre-Approval Inspection (PAI) was conducted for a first-to-file controlled substance ANDA, resulting in one observation which has been resolved. This development signifies the successful completion of the FDA inspection process and compliance with regulatory standards. Please note that the information shared is intended solely for informational purposes and does not make any investment recommendations.