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Therapeutic Grade
Key Features
- cGMP manufacturing facility
- Full regulatory support and documentation
- Scalable production from clinical to commercial
- Comprehensive quality assurance program
- IND-enabling documentation package
- Stability studies and shelf-life testing
Applications
- IND-enabling studies
- Phase I-III clinical trials
- Commercial manufacturing
- Regulatory submissions
- Process development
Specifications
| Purity | ≥99.0% by HPLC (GMP) |
| Scale | 100 mg to 10 kg |
| Compliance | FDA 21 CFR Parts 210/211 |
| Documentation | Full DMF package |
| Stability | ICH-compliant studies |
| Facility | ISO 7 cleanroom |