Nitrosamine contamination remains a critical concern for the pharmaceutical industry, requiring reliable solutions. Dipharma, a CDMO and a leading manufacturer of high-quality APIs, New Chemical Entities (NCEs), and advanced Intermediates for generic and contract manufacturing markets, has proactively developed a robust risk assessment protocol aligned with EMA and FDA guidelines.

Dipharma’s comprehensive approach integrates cutting-edge technology and stringent quality control throughout its manufacturing processes, minimizing nitrosamine risk and safeguarding product quality. The company operates four manufacturing sites, three in Italy and one in the U.S., along with two advanced research centers in Baranzate (Italy) and Kalamazoo (USA).

With 75 years of experience and over 50 years of successful inspections by major regulatory agencies such as the FDA, AIFA, PMDA, Korean FDA and ANVISA, Dipharma offers exceptional expertise in assessing, detecting, and controlling nitrosamines across the pharmaceutical supply chain.

Serving over 60 countries, Dipharma partners with leading pharmaceutical companies to develop both generic and custom APIs, ensuring compliance with the highest quality and safety standards.

The Company employs advanced analytical techniques, such as an innovative ¹⁵N-NMR approach, rigorous quality control and risk mitigation measures, and process optimization strategies to help pharmaceutical companies meet regulatory requirements and address specific challenges. Its dedicated R&D team continuously develops innovative methodologies to prevent nitrosamine formation and ensure product safety.

Dipharma has successfully implemented its nitrosamine control strategies across multiple APIs. Partnering with Dipharma means benefiting from a science-driven, solution-oriented approach that prioritizes safety, efficiency, and compliance.

Choose Dipharma as your partner in nitrosamine control and secure the future of your pharmaceutical products. Enjoy reading the white paper and discover how Dipharma can support your efforts in maintaining the highest standards of quality and compliance:  https://www.dipharma.com/download-area/