SPI Pharma Completes Nitrosamine Testing Program for Mannogem
SPI Pharma has successfully completed a comprehensive nitrosamine risk assessment and analytical testing program for Mannogem™, reinforcing its commitment to supporting customers in an increasingly complex regulatory environment.
Over the past several years, nitrosamines have become a key focus for global regulatory authorities, with evolving guidance from agencies such as the FDA and EMA introducing new expectations around risk assessment, acceptable intake limits, and ongoing compliance. These developments have shifted the conversation beyond one‑time testing to a more continuous, science‑driven approach to governance and control.
Proactively Addressing a Changing Landscape
Recognising this shift, SPI Pharma undertook a detailed evaluation of Mannogem, applying advanced analytical techniques to assess the potential presence of nitrosamines at trace levels. The programme was designed to align with current regulatory thinking and emerging best practices, ensuring both scientific robustness and practical relevance for customers.
This work reflects a broader industry trend: nitrosamine control is no longer just about detection, but about demonstrating a clear, defensible understanding of risk across materials, processes, and supply chains.
Supporting Customer Confidence
The successful completion of this programme provides customers with greater confidence in Mannogem as part of their formulation strategies, particularly as regulatory scrutiny continues to evolve.
By investing in high‑sensitivity testing capabilities and structured risk assessment frameworks, SPI Pharma aims to help customers navigate:
- Increasingly detailed regulatory expectations
- Expanding lists of nitrosamine compounds and intake limits
- Greater emphasis on documentation and scientific justification
- The need for ongoing, “living” risk assessments
A Collaborative Approach to Nitrosamine Control
Today’s nitrosamine landscape highlights how interconnected the industry has become. Raw material suppliers, API manufacturers, and finished dosage form developers all play a role in ensuring compliance and maintaining product quality.
SPI Pharma’s approach is grounded in collaboration—working closely with customers to provide data, insights, and technical support that enable informed decision‑making.
Looking Ahead
As regulatory guidance continues to evolve, SPI Pharma remains committed to staying at the forefront of nitrosamine science. Ongoing monitoring, investment in analytical capabilities, and active engagement with industry developments will ensure that Mannogem® and the broader portfolio continue to meet the highest standards.
Learn more about SPI Pharma’s approach to nitrosamine risk management and how we can support your development and compliance strategies.