Bengaluru: Syngene International Limited has recently announced that the US Food Drug Administration (USFDA) has successfully concluded a pre-approval inspection with Zero 483 observations at the company’s Biologics facility in Bangalore.
“This is to inform you that the US Food and Drug Administration (USFDA) has conducted its pre-approval
inspection of the Biologics facility at Bangalore from November 07, 2022, till November 15, 2022. The
inspection was completed successfully without 483 observations,” the company said in a BSE filing.
inspection of the Biologics facility at Bangalore from November 07, 2022, till November 15, 2022. The
inspection was completed successfully without 483 observations,” the company said in a BSE filing.
The inspection was conducted from November 07, 2022, to November 15, 2022.
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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 a combination of research facilities for
Amgen, Baxter, and Bristol-Myers Squibb as well as 2 Mn sq. ft of specialist discovery,
development, and manufacturing facilities, Syngene works with biotech companies pursuing
leading-edge science as well as multinationals, including GSK, Zoetis, and Merck KGaA.
research, development, and manufacturing services company serving the global pharmaceutical,
biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. With a combination of research facilities for
Amgen, Baxter, and Bristol-Myers Squibb as well as 2 Mn sq. ft of specialist discovery,
development, and manufacturing facilities, Syngene works with biotech companies pursuing
leading-edge science as well as multinationals, including GSK, Zoetis, and Merck KGaA.