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Cipla Receives US FDA Form 483 for Goa Facility Inspection

Synopsis:

Cipla's Medispray unit in Goa received one US FDA Form 483 observation after a detailed inspection. The company is addressing the issue within FDA timelines. Cipla share price closed at ₹1,445.90 on January 20, 2025, marginally up by 0.24%.

Cipla news today

Pharmaceutical giant Cipla announced that the US FDA inspected its subsidiary Medispray Laboratories in Kundaim, Goa, between 14-20 January 2025. Following the inspection, the facility received a single observation documented in Form 483. Cipla assured stakeholders of its commitment to addressing the observation promptly within the stipulated timeline, ensuring strict adherence to Good Manufacturing Practices (GMP).

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CIPLA LTD

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1456.8511.40 (0.78 %)

Updated - 21 January 2025
1464.80day high
DAY HIGH
1447.95day low
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794
VOLUME (BSE)

Key Takeaways:

  • Facility Location: Medispray Laboratories, Kundaim, Goa

  • Inspection Period: 14-20 January 2025

  • Observation: One Form 483 issued by the US FDA

  • Action Plan: Cipla will respond to the FDA within 15 days

  • Cipla Share Price: Closed at ₹1,445.90 on January 20, 2025

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What Is Form 483?

Form 483, issued by the US FDA, lists observations made during inspections regarding potential deviations from GMP. It is not a final determination but serves as a preliminary communication. Companies receiving Form 483 have 15 days to submit corrective actions to the FDA, showcasing their compliance plan.

Inspection Details

Information

Facility Name

Medispray Laboratories

Location

Kundaim, Goa

Inspection Duration

14-20 January 2025

Observations (Form 483)

1

Cipla Share Price Movement

On the day of the announcement, Cipla share price ended at ₹1,445.90, marking a 0.24% increase. Investors are monitoring the situation as Cipla’s commitment to GMP compliance and prompt issue resolution reflects its operational reliability.

Cipla’s Response Plan

Cipla emphasised its proactive approach, stating that the observation would be addressed comprehensively within the stipulated timeline. This reflects Cipla’s strong compliance framework and its dedication to maintaining FDA standards.

The US FDA Form 483 observation highlights areas requiring attention but does not indicate significant non-compliance. Cipla’s transparent communication and swift corrective measures underscore its focus on regulatory adherence, instilling confidence in stakeholders. With a resilient operational framework, Cipla remains poised to resolve the issue efficiently.

Also read: Reliance Power Appoints Neeraj Parakh as CEO for Three Years

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This content is for educational purposes only. Securities quoted are exemplary and not recommendatory.

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