cGMP Services
When your API is ready to transition to the clinic, PharmAgra Labs can rapidly and economically meet your requirements for API Clinical Trial Material. We synthesize milligram to multi-kilogram lots for clinical studies and low volume commercial production in our cGMP synthesis laboratory (see facility section). A wide range of chemical processes can be accommodated in glass reactors up to 72 liters. Larger quantities can be accommodated by transfer to large scale cGMP manufacturers.
We are an FDA inspected facility. We successfully completed our first FDA pre-approval inspection (PAI) in July of 2009 with no 483's issued.
Our cGMP services include:
- Synthesis of milligram to multi-kilogram lots for clinical studies and commercial production
- Process validation
- IND / NDA / ANDA support documentation
- Impurity isolation, characterization and synthesis
- Analytical methods development and validation
- Impurities identification and synthesis
- Reference standard preparation, characterization and documentation
- API stability studies according to ICH guidelines
- Product release testing
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