API Manufacturing

Reliable Biopharmaceutical is an integrated 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.

• US Manufacturer
• FDA Inspected
• Leader in GMP Purification Technology
• Drug Master File Preparation & Maintenance
• 10 Commercial Active Pharmaceutical Ingredients (API)
• R&D, Quality by Design and DOE
• Cyto-toxic Compound Handling Capabilities
• Multiple High Potency Containment Suites
• Multistep Organic Production
• Complete Analytical Support
• Methods Development
• Assay Validation & Stability Studies
• Reference Standards
• Impurity Standards
• Process Validation
• CMC support for ANDA & IND submissions
• Confidential