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Active Product Ingredients (API) Manufacturing
Reliable Biopharmaceutical is an integrated injectable API development & cGMP manufacturing partner that provides security & speed to market approval through full project management including complex science, regulatory & analytical expertise and open communication.
- FDA Inspected
- Drug Master File Preparation & Maintenance
- Active Product Ingredients (API) Process Development: Exclusive, Proprietary & Non-Proprietary
- Cyto-toxic Compound Handling Capabilities
- 12 Referenced Type II DMFs; 10 Type II DMFs in process
- Multiple High Potency Containment Suites
- Multistep Organic Production
- Specializing in Nucleoside Therapeutics
- Complete Analytical Support
- Methods Development
- Assay Validation & Stability Studies
- Reference Standards; Impurity Standards
- Process Validation
- CMC support for ANDA & IND submissions
- Confidentiality & Exclusive Production
- 5-200 L Reaction vessels; 300 L resin columns; 80L, 40L, 20L SiO2 columns
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