Forward-thinking CDMO tackles the dynamic challenge of N-nitrosamines control with high-performance analytical instrumentation

Poland-based Polpharma API relies on Waters analytical instrumentation for impurities method development and testing to meet the ever-evolving regulatory guidance around N-nitrosamines (nitrosamines) control in active pharmaceutical ingredients (API).

API purity

Register your details to discover more about meeting global nitrosamine requirements, LC-MS/MS for identification and quantification of nitrosamines and how you can adapt to evolving trends.

API method development and testing at Polpharma API

As a key player in the Polish pharmaceutical market and a prominent drug manufacturer in Central and Eastern Europe, Polpharma API exports medicinal products to 35 markets and active pharmaceutical ingredients (APIs) to over 60 countries. Its API manufacturing facilities undergo stringent inspections from regulatory authorities such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). As the largest Polish API manufacturer, Polpharma API offers a diverse portfolio of pharmaceutical products and CDMO solutions globally, providing services from initial development (for early stages of new chemical entities [NCEs]) to process development, validation, and commercial API manufacturing.