As your Active Pharmaceutical Ingredient (API) progresses from the research phase to production, Raybow USA stands ready to support you with rapid, efficient, and economical nonGMP synthesis.

Raybow USA is committed to supporting your journey from laboratory research to market success.

Advanced nonGMP Synthesis Laboratory

• Raybow USA’s GMP synthesis laboratory is designed to handle a wide array of chemical processes.

• Glass reactors capable of accommodating up to 72 liters ensure precision and quality control for each batch.

• Synthesis chemists involved in the process development remain engaged into nonGMP production provide project continuity.

Comprehensive Range of nonGMP Services 

• API Synthesis: From milligram to kilogram scale, accommodating the varying needs.

• Process Validation: Ensuring that every stage of the API production is efficient, compliant, and reproducible.

• Impurity Management: Including isolation, characterization, and synthesis of impurities.

• Analytical Development and Validation: Creating and validating methods for accurate API analysis.

• Reference Standard Services: Preparing, characterizing, and documenting reference standards.

• ICH-Guided API Stability Studies: Conducting comprehensive stability studies in line with ICH guidelines.

• Product Release Testing: Rigorously testing to ensure the quality and safety of the API.

Raybow USA and other Jiuzhou Pharma facilities are equipped to synthesize API Material, moving your product toward marketable commercial production.