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Biocon Achieves VAI Status for Bengaluru Facility After US FDA Inspection

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Synopsis:

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 news today

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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BIOCON LIMITED.

Trade

311.85-14.89 (-4.55 %)

Updated - 25 April 2025
328.40day high
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308.45day low
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2976111
VOLUME (BSE)

Key Takeaways

  • 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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What Is VAI Status?

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)

Implications for Biocon Share Price

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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