Granules India arm gets 1 USFDA observation for Hyderabad facility
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Hyderabad: Granules India has announced that the U.S. Food and Drug Administration (USFDA) has issued one observation for the facility of Granules Life Sciences Private Limited, a wholly owned Indian subsidiary of the Company, located at Shamirpet Mandal, Hyderabad.
A Pre-Approval Inspection (PAI) was held from July 28, 2025 to August 01, 2025.
Read also: Granules India Riaz Ahmed resigns as Senior Vice President & Head- Supply Chain Management
"The US FDA has completed a Pre-Approval Inspection (PAI) from July 28, 2025 to August 01, 2025 at the facility of M/s. Granules Life Sciences Private Limited., a wholly owned Indian subsidiary of the Company, located at Shamirpet Mandal, Hyderabad with 1 (One) 483 observation which is procedural in nature. The Company will respond to this observation within the stipulated time," Granules India stated in a BSE filing.
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