Syngene International gets 5 USFDA observations for Bengaluru facilities
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-02-24 06:00 GMT | Update On 2025-02-24 06:00 GMT
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Bengaluru: Syngene International has announced that the U.S. Food and Drugs Administration (USFDA) has concluded the inspection with five observations at the Company's Bengaluru facilities.
The pre-approval and cGMP inspection covering commercial manufacturing activities for the US market was conducted from February 10, 2025 till February 20, 2025.
"On conclusion of the inspection, the USFDA issued Form 483 with 5 (Five) observations. The Company will work closely with USFDA and remains committed to addressing these observations comprehensively within the stipulated time," Syngene stated in a BSE filing.
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