Piramal Pharma Marks Major Milestone in Nitrosamine Compliance

Piramal Pharma Solutions announced today that it has completed its journey to global nitrosamine compliance, marking a major step in strengthening patient safety and meeting evolving international expectations for nitrosamine impurities in medicines.

This achievement reflects rapid action taken as regulators worldwide tightened standards for nitrosamine drug substance–related impurities (NDSRIs).

The company began by forming a cross-functional team of experts from Regulatory Affairs, Central Quality, R&D, and Manufacturing. Their role was to interpret new guidance as it emerged and ensure every site stayed aligned with international rules. A key outcome of their work was the Position Paper, an internal guide that clarified responsibilities and helped teams adjust to new compliance demands.

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Rashida Najmi, Chief Quality Officer, Piramal Pharma Limited said, "With our proactive approach and enhanced capabilities, we are well-equipped to adapt to evolving global NDSRI standards, ensuring the highest safety and quality standards for our products."

Risk assessment became a core part of the process. Every relevant drug substance and product was evaluated for potential NDSRIs, followed by confirmatory testing and the introduction of tailored control strategies. All commercial products from Piramal Pharma Limited now meet global requirements, while a few customer products remain under regulatory review. New batches will move forward only after full alignment.

To support sustained nitrosamine compliance, Piramal invested in advanced testing capabilities at its Ahmedabad and Digwal development sites and qualified additional external labs. These upgrades help reduce testing timelines, prevent shortages, and address industry-wide challenges around impurity standards and synthesis. The new capabilities also allow the company to create and qualify impurities in-house and conduct deeper screening to safeguard product quality.

As global guidelines continue to evolve, the company plans to maintain transparent communication with partners and uphold the highest standards of pharmaceutical quality and safety.