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Syngene International gets 5 USFDA observations for Bengaluru facilities

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.
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.
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751