Piramal Pharma Shares Drop 3.5% After USFDA Issues Six Observations

Piramal Pharma’s stock fell 3.5% on February 19 after the company received six observations from the USFDA. At 9:19 AM, shares were trading at ₹190.65, down ₹7.00 (3.54%) on the BSE. The USFDA conducted a GMP inspection at its Turbhe facility from February 11-17, 2025, concluding with a Form 483 citing procedural improvements rather than data integrity concerns. Piramal Pharma is preparing a detailed response for submission within the stipulated timeline and reaffirmed its commitment to high compliance standards. In Q3FY25, the company’s net profit dropped 63.6% YoY to ₹3.68 crore from ₹10.1 crore, while revenue increased 12.5% YoY to ₹2,204.2 crore. Despite the regulatory observations, the company remains confident in effectively addressing the issues raised.

CONTENTS:

• Pharma’s Mumbai Facility Receives Six Observations from US FDA Inspection
• Piramal Q3FY25 Performance
• Piramal Pharma Shares Drop 3.5% Following USFDA Observations
• Q3FY25 Financial Performance

Piramal Pharma Shares Drop 3.5% After USFDA Issues Six Observations

Piramal Pharma’s Mumbai Facility Receives Six Observations from US FDA Inspection

On Tuesday, February 18, Piramal Pharma Ltd announced that the US FDA had conducted a Good Manufacturing Practice (GMP) inspection at its Turbhe, Navi Mumbai facility between February 11 and 17, 2025. Following the inspection, the regulatory body issued a Form 483 with six observations.

The company clarified in a regulatory filing that these observations primarily relate to procedural enhancements and do not involve data integrity concerns. Piramal Pharma is currently preparing a comprehensive response, which it intends to submit within the required timeframe.

Reaffirming its commitment to regulatory compliance, the company expressed confidence in addressing the observations effectively.

Piramal Pharma’s Q3FY25 Performance

For the third quarter ending December 31, 2024, Piramal reported a 63.4% decline in net profit year-over-year, falling to ₹3.7 crore from ₹10.1 crore in the same period last fiscal. However, revenue from operations increased by 12.5% to ₹2,204.2 crore, compared to ₹1,958.6 crore in the previous year. Meanwhile, EBITDA saw a 25.8% rise, reaching ₹337.7 crore from ₹268.4 crore in Q3FY24.

Despite these developments, shares of  Pharma Ltd closed at ₹196.70 on the BSE, reflecting a decline of ₹3.15 or 1.58%.

Piramal Pharma Shares Drop 3.5% Following USFDA Observations

Pharma’s stock declined by 3.5% during early trading on February 19 after the company received six observations from the United States Food and Drug Administration (USFDA).

At 9:19 AM, the stock was trading at ₹190.65 on the BSE, marking a drop of ₹7.00 or 3.54%.

The USFDA conducted a Good Manufacturing Practice (GMP) inspection at Piramal Pharma’s Turbhe facility between February 11 and 17, 2025. Following the inspection, a Form 483 was issued with six observations, primarily related to procedural and operational improvements rather than data integrity concerns.

Piramal Pharma stated that it is preparing a detailed response, which will be submitted within the required timeline. The company reaffirmed its commitment to maintaining high compliance standards and expressed confidence in effectively addressing the observations.

Q3FY25 Financial Performance

In the third quarter of FY25, Piramal reported a 63.6% year-on-year decline in consolidated net profit, which fell to ₹3.68 crore from ₹10.1 crore in the same quarter last year. However, the company’s revenue saw a 12.5% increase, reaching ₹2,204.2 crore compared to ₹1,958.6 crore in Q3FY24.

Piramal Pharma’s stock declined 3.5% on February 19 after receiving six USFDA observations following a GMP inspection at its Turbhe facility from February 11-17, 2025. The issued Form 483 highlighted procedural improvements but did not raise data integrity concerns. The company is preparing a detailed response and remains confident in addressing the issues. In Q3FY25, net profit dropped 63.6% YoY to ₹3.68 crore, while revenue grew 12.5% to ₹2,204.2 crore. EBITDA also rose 25.8%, reaching ₹337.7 crore. Despite regulatory concerns, Piramal Pharma reaffirmed its commitment to compliance.