Business
Piramal Pharma Solutions Achieves Regulatory Compliance for Nitrosamine Impurities
Piramal Pharma Solutions, a leading global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd. (NSE: PPLPHARMA) (BSE: 543635), today announced the successful completion of its journey to compliance with global requirements for nitrosamine impurities in pharmaceuticals.
About this update from Piramal Pharma Limited
[{"type":"list","items":[{"val":[{"type":"text","content":"Piramal Pharma Solutions implemented a robust action plan to address evolving regulatory requirements pertaining to nitrosamine impurities. ","length":139,"tagName":"p"}]},{"val":[{"type":"text","content":"Through comprehensive risk assessments, confirmatory testing, and control strategies, the Company is ensuring the safety and compliance of its drug substances and drug products. ","length":177,"tagName":"p"}]},{"val":[{"type":"text","content":"By investing in site improvements and capability enhancements, the Company will continue to meet international regulatory guidelines for nitrosamines. ","length":150,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":466,"olType":false},{"type":"text","content":"MUMBAI, India, Nov. 26, 2025 /PRNewswire/ -- Piramal Pharma Solutions, a leading global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd. (NSE: PPLPHARMA) (BSE: 543635), today announced the successful completion of its journey to compliance with global requirements for nitrosamine impurities in pharmaceuticals.","length":353,"tagName":"p"},{"type":"image","alt":"Rashida Najmi, Chief Quality Officer, Piramal Pharma Limited.","displaySize":"","headline":null,"caption":"Rashida Najmi, Chief Quality Officer, Piramal Pharma Limited.","className":"","disableSlideshowImg":false,"size":{"original":{"width":266,"height":400,"url":"https://media.zenfs.com/en/prnewswire.com/f2ce8bf466df7fb51d2aa2cf2ea5d6d3"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/mvnAQwXk0IsCiKSgbWq_mA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTYzMjtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/f2ce8bf466df7fb51d2aa2cf2ea5d6d3","width":266,"height":400}},"href":"https://mma.prnewswire.com/media/2833065/Rashida_Najmi.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"Nitrosamines are unintended carcinogenic byproducts that can be found in certain medications. International guidelines on nitrosamine drug substance-related impurities (NDSRIs) have evolved significantly over the last few years, requiring pharmaceutical companies to adapt their operations to maintain compliance. In response, Piramal Pharma Solutions has implemented a robust, multi-step action plan to ensure regulatory alignment with the latest NDSRI guidelines, and more importantly, patient saf...