Syngene International Ltd, the leading integrated research, development, and manufacturing services group, has been issued the Establishment Inspection Report (EIR) by the US Food and Drug Administration (USFDA) for Bengaluru. The inspection result has been classified as "Voluntary Action Indicated" (VAI), and it reflects the company's sustained direction towards regulatory compliance and quality.
Key Highlights:
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USFDA conducted a pre-approval and current Good Manufacturing Practice (cGMP) inspection of Syngene's Bengaluru facility from February 10 through February 20, 2025.
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At the end of the inspection, the USFDA had given a Form 483 with five observations, which are places for improvement but not for regulatory action at the current time.
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Syngene forthwith expressed its willingness to seriously deliberate on these observations within the specified timeframe and work in close contact with the USFDA to resolve all concerns.
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The inspection outcome, "Voluntary Action Indicated," means that a number of corrections need to be made, but the facility is not in any formal regulatory or enforcement action at present.
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The company continues to provide robust growth to international pharmaceutical, biotech, nutrition, animal health, consumer goods, and specialty chemicals segments, with 17.58% year-on-year consolidated net profit growth in Q3 FY25.
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Syngene's purchase of the EIR and VAI status reflects its commitment to maintaining high levels of quality and regulatory compliance in business.
"The company will be in close liaison with USFDA and is committed to addressing these observations in a comprehensive manner within the stipulated time," Syngene International said in a statement.
Source: Business Standard, Medical Dialogues, StockInsights.ai, JM Financial Services, LinkedIn