Syngene International gets USFDA EIR for Bengaluru GMP manufacturing facilities
Karnataka: Syngene International has announced that the Company has received Establishment Inspection Report (EIR) from US Food and Drugs Administration (USFDA) for its GMP manufacturing facilities located at Biocon Park, SEZ, Bengaluru.
The EIR concluded the inspectional outcome as Voluntary Action Indicated (VAI). VAI which means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action
"The US FDA has reviewed and accepted Syngene’s responses and Corrective and Preventive Action (CAPA) plans submitted in response to the inspectional findings. Syngene will continue to provide periodic updates to the USFDA on the progress of corrective actions submitted to the agency. We remain committed to maintaining the highest standards of regulatory compliance and this outcome will not have any adverse impact on the Company’s financials or operations," Syngene stated in a BSE filing.
The inspection was conducted from February 10, 2025, to February 20, 2025.
In February, the company received Form 483 with five observations from the USFDA for its 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.
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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