With just months remaining until the FDA expects drug developers to comply with the new regulations related to the Acceptable Intake (AI) limits for nitrosamines, it is a great time to take a closer look at a unique and powerful active packaging-based solution: Aptar CSP’s N-Sorb technology. Part of the FDA’s Emerging Technology Program, N-Sorb delivers an active packaging-based solution to quickly address nitrosamine risk mitigation without the reformulation work that can take years, offering a powerful tool to help pharma companies comply with the new regulations by the deadline. Testing of this solution continues to demonstrate strong ability to reduce nitrosamine levels to below the AI limits set by the FDA and other global authorities, making it a versatile solution for various drug formulations susceptible to nitrosamine formation during manufacturing, storage, or distribution.

Part of the FDA’s Emerging Technology Program, Aptar CSP is uniquely positioned to assist pharmaceutical companies in navigating the complex regulatory landscape surrounding nitrosamine control. With a long history of regulatory compliance, including multiple approved drugs already on the market, Aptar CSP provides expert guidance on nitrosamine control documentation. We are committed to supporting manufacturers through successful regulatory submissions and ensuring compliance with evolving global requirements. Click here to view our regulatory position paper and learn how N-Sorb fits into the overall global regulatory landscape.