Generic Small Molecule Drugs ◆ Advanced Technology Lab

 

UBI Pharma Inc. offers comprehensive one-stop services and innovative solutions for pharmaceutical development. We specialize in providing both small molecules and peptide drugs liquid and freeze-dried injectables, as well as combination tablets, adhering to both non-GMP and GMP standards.

Our commitment to pharmaceutical development and production encompasses the entire quality control process, from the assessment of raw materials, rigorous release testing to the design and monitoring of production processes, final product testing, and stability assessments which determine drug shelf-life. Furthermore, we prioritize the reliability of our pharmaceuticals by subjecting them to series rigorously validated analysis methods.

UBI Pharma Inc. assists clients in method development, tech transfer, validation, verification, process development, scale-up, and drug stability testing and are committed to ensuring our products, from research and development to commercial production, meet the international regulatory requirements, such as the USFDA, EMA, PMDA and TFDA.

Our Capabilities

  • Development and validation of analytical methods

  • Quality analysis of raw material and finished drug product

  • Production process and scale-up development through QbD (Quality by Design)

  • Packaging functionality and compatibility evaluation

  • Stability evaluation on finished drug product


 

Cutting-Edge Instruments/Equipment Suite

Quality Analysis

  • HPLC (Agilent, Waters)
  • Waters Acquity H-Class UPLC System
  • Waters Acquity H-Class UPLC TQ-S MS System
  • ThermoFisher ACC-3000 Ion Chromatography Systems
  • Agilent GC System
  • Karl Fischer titrator
  • Distek 2500 dissolution tester
  • Nippon Denshoku NE-4000 Color Meter
  • Metrohm 888 Titrator
  • Agilent ICP-MS
  • Milestone ETHOS UP Microwave Digestion System
  • Endotoxin kinetic analysis system

Process Development

  • Lyophilized injectable development:0.5 m2 Lyophilizer
  • Tablet development:
    • Granulator
    • Fitz Mill
    • Fluid Bed
    • Single-Sided/ Double Sided Tabletting Machine
  • Coater
  • PFS filling and stoppering machine

Packaging Functional Analysis

  • Liquid tracer tester
  • Puncture force tester

Product Stability

  • Photostability chamber
  • Stability chamber