PIRAMAL PHARMA LIMITED

Piramal Pharma Solutions Achieves Full Regulatory Compliance for Nitrosamine Impurities

- Piramal Pharma Solutions has successfully completed its comprehensive action plan to achieve regulatory compliance with global nitrosamine drug substance-related impurities (NDSRI) guidelines. - The company implemented extensive risk assessments, confirmatory testing, and control strategies across all drug substances and products to ensure patient safety. - Significant investments were made in state-of-the-art testing equipment and capabilities at Ahmedabad and Digwal facilities to expedite compliance processes and prevent drug shortages. - All existing Piramal commercial products now comply with global regulatory requirements, with new customer product batches requiring regulatory alignment before execution.