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

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.

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Read also: Syngene International: Peter Bains returns as CEO, Jonathan Hunt steps down

Medical Dialogues team had earlier reported that Biocon had sold Eighty Lacs equity shares of Syngene International Limited for Rs. 686 crores. The transacted value was the gross amount on the exchange and was subject to statutory levies, brokerage etc.

The shares were sold in the open market through a block deal mechanism on December 10, 2024

Read also: Biocon sells 80 lacs equity shares of Syngene International for Rs 686 crores

Syngene International Ltd. is an integrated research, development, and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. With 2.2 Mn sq. ft of specialized discovery, development, and manufacturing facilities, Syngene works with biotech companies pursuing leading-edge science as well as multinationals, including BMS, GSK, Zoetis and Merck KGaA.

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