Azopharma has custom synthesis capabilities to manufacture cGMP supplies of active pharmaceutical ingredients (APIs). We can also synthesize advanced intermediates to support lead optimization programs. Azopharma can develop a custom synthetic process for APIs or optimize an existing process as provided by the client.

All cGMP APIs are manufactured in environmentally monitored clean room suites equipped with separate air-handling systems and HEPA-filtered air under negative pressure to assure no cross-contamination.

Synthesis activities are complemented with analytical support and characterization capabilities to assure product identity and purity. Our analytical team also provides in-process testing, reaction end-point monitoring and identification of impurities and byproducts.

Service/Capabilities

Scale-up and process optimization Reference standardsfrom milligram scale to multi-kilo scale Marker compounds Dedicated glassware and equipment Peptides and conjugated large molecules Building block chemistries Medicinal chemistry libraries Novel route design Controlled substances Literature synthesis Preparative chromatography Potent cytotoxic compounds CMC regulatory support Reference standardsfrom milligram scale to multi-kilo scale Marker compounds Peptides and conjugated large molecules Medicinal chemistry libraries Controlled substances Preparative chromatography CMC regulatory support Marker compounds