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Biocon’s Bengaluru API facility received a Voluntary Action Indicated (VAI) status from the US FDA. The inspection, held from 16-20 September 2024, is officially closed. This development positively impacts Biocon share price and operations.
Biocon, a leading biopharmaceutical company, has achieved Voluntary Action Indicated (VAI) status from the US FDA for its API facility (Site 1) in Bengaluru, Karnataka. The inspection, conducted between 16 and 20 September 2024, is now closed as per 21 CFR20.64(d)(3). This status indicates that the facility adheres to regulatory compliance without requiring further action.
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Inspection Details: Conducted from 16-20 September 2024 by the US FDA.
Facility Location: API facility (Site 1), Bengaluru, Karnataka.
Regulatory Status: VAI indicates no further regulatory action is needed.
Impact on Biocon Share Price: A positive influence is anticipated in investor sentiment.
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Voluntary Action Indicated (VAI) status signifies that the inspected facility meets required compliance standards. No critical observations were reported, and the Establishment Inspection Report (EIR) confirmed the closure of the inspection.
Details of Inspection | Information |
Facility Name | API Facility (Site 1) |
Location | Bengaluru, Karnataka |
Inspection Dates | 16-20 September 2024 |
FDA Status | VAI (Voluntary Action Indicated) |
The receipt of VAI status bolsters Biocon's credibility in the pharmaceutical sector. This development is expected to positively influence Biocon share price, reinforcing investor confidence in the company’s manufacturing capabilities. The Bengaluru facility is a critical asset for Biocon’s API production and global supply chain, making this regulatory approval a significant achievement.
Biocon’s successful closure of the US FDA inspection with a VAI status for its Bengaluru API facility underscores its adherence to stringent regulatory standards. This milestone strengthens its market reputation and operational efficiency, potentially driving further growth in Biocon share price.
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