Syngene International gets USFDA EIR for Bengaluru GMP manufacturing facilities

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-06-16 04:45 GMT | Update On 2025-06-16 04:45 GMT

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.

Read also: Priyadarshini Mahapatra to exit Syngene International as Head Legal, Company Secretary & Compliance Officer

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.

Read also: Syngene International gets 5 USFDA observations for Bengaluru facilities

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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Ruchika Sharma

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

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Syngene International gets USFDA EIR for Bengaluru GMP manufacturing facilities

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