USFDA successfully concludes inspection at Syngene Bangalore facility
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.
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.
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