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