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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 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.
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 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.
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) |
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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.
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