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Cipla Receives US FDA Form 483 with Eight Observations at Bengaluru Unit

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Synopsis:

Cipla's Virgonagar manufacturing unit received eight US FDA observations after an inspection from November 7-13, 2024. Cipla share price dropped 1.3% post-announcement to ₹1,505.60.

Cipla news today

Cipla Ltd announced that the US FDA has issued Form 483 with eight observations for its Virgonagar manufacturing facility in Bengaluru. The inspection, conducted from November 7 to November 13, 2024, highlighted areas requiring improvement to meet manufacturing compliance standards. Cipla has assured its commitment to addressing all points within the stipulated timeline.

CIPLA LTD

Trade

1525.9-25.79 (-1.66 %)

Updated - 25 April 2025
1566.70day high
DAY HIGH
1513.50day low
DAY LOW
935500
VOLUME (BSE)

Key Takeaways:

  • Inspection Dates: November 7–13, 2024.

  • Number of Observations: 8.

  • Facility Inspected: Cipla's Virgonagar, Bengaluru-based manufacturing unit.

  • Regulatory Document: US FDA Form 483.

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Cipla’s Financial Performance Amid Regulatory Scrutiny

Cipla’s regulatory challenge comes as the company posted robust financial results for the September quarter. Cipla reported a consolidated net profit of ₹1,303 crore, a significant growth from the previous year, supported by revenues of ₹7,051 crore. However, the announcement of the FDA observations led to a 1.3% dip in Cipla share price, closing at ₹1,505.60 on November 13, 2024.

Cipla’s Q2 FY24 Financial Summary

Metric

Q2 FY24

YoY Change

Net Profit (₹ crore)

1,303

+15.3%

Revenue (₹ crore)

7,051

+12.5%

Cipla Share Price (₹)

1,505.60 (NSE)

-1.3% (Post News)

Also read: Morgan Stanley Acquires 1.4 Crore PNB Housing Finance Shares for ₹1,336 Crore

Implications For Cipla Share Price And Market Sentiment

The issuance of Form 483 may impact Cipla share price in the short term as investors evaluate potential regulatory and operational consequences. Cipla’s prompt response to address the FDA’s concerns could mitigate any prolonged effects.

Cipla’s regulatory compliance efforts will be closely monitored as the company works to resolve the observations. Despite this setback, Cipla remains well-positioned with strong financials and market presence.

Also read: Tata Power Commissions 126 MW Floating Solar Project in Madhya Pradesh

Disclaimer: Investments in the securities market are subject to market risk, read all related documents carefully before investing.

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

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