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

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