Piramal Pharma receives Form-483 with six observations for Turbhe facility from US FDA

Piramal Pharma Limited’s Turbhe facility underwent a General GMP (Good Manufacturing Practices) inspection by the US FDA from February 11th to 17th, 2025. At the conclusion of the inspection, the company received a Form-483 with six observations. The observations primarily focus on procedural improvements and practices, rather than any concerns related to data integrity.

Piramal Pharma is actively working on a comprehensive response to these observations, which will be submitted to the FDA within the required timelines. The company is committed to upholding the highest standards of compliance and is confident in addressing the observations effectively.

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Piramal Pharma Q3 results

Piramal Pharma reported a decline in net profit for Q3 FY25, down to ₹3.7 crore from ₹10.1 crore in Q3 FY24. Despite this, the company posted a 12.5% increase in income from operations, reaching ₹2,204.2 crore, up from ₹1,958.6 crore year-on-year.

Key highlights include a 25.8% rise in EBITDA, totaling ₹337.7 crore, with an improved EBITDA margin of 15.3%, up from 13.7% in the previous year. The net-debt-to-EBITDA ratio remained stable at 2.8x.

Piramal Pharma’s Contract Development and Manufacturing Organization (CDMO) saw strong growth driven by on-patent commercial manufacturing and robust performance in the generic API sector. The Complex Hospital Generics (CHG) segment also posted solid results, particularly in the US, with growth in inhalation anesthesia products like Sevoflurane and Isoflurane.

The India Consumer Healthcare (ICH) segment continued to perform well, with Power Brands like Little’s, Polycrol, and CIR delivering a 19% year-on-year growth, despite the broader industry’s subdued demand.