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Formurex Presentation


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Formurex Presentation

  1. 1. <ul><ul><li>Welcome </li></ul></ul>
  2. 2. <ul><li>Formurex is a contract research organization that serves the pharmaceutical industry in drug formulation development . </li></ul><ul><li>We also manufacture drug materials to support Phase I clinical trials under GMP environment. </li></ul>The Company & Values
  3. 3. <ul><li>Our Values </li></ul><ul><ul><ul><li>Quality </li></ul></ul></ul><ul><ul><ul><li> Professionalism </li></ul></ul></ul><ul><li> Respect </li></ul><ul><ul><ul><li> Innovation </li></ul></ul></ul>
  4. 4. <ul><li>Mission Statement </li></ul><ul><li>Our mission is to serve the pharmaceutical and biotech industry to advance medicine from bench to bedside using cutting edge technologies in drug formulation and delivery. </li></ul>
  5. 5. <ul><li>SERVICES </li></ul>
  6. 6. Formulation Development Analytical Services GMP Manufacturing Pre-Formulation Stability Studies
  7. 7. <ul><li>Preformulation Services </li></ul>
  8. 8. <ul><li>Solubility Testing & Enhancement </li></ul><ul><li>Permeation Testing & Enhancement </li></ul><ul><li>Drug-Excipient Compatibility Studies </li></ul><ul><li>Moisture Uptake / Hygroscopicity </li></ul><ul><li>Density and Compressibility </li></ul><ul><li>Surface Morphology and Particle Size Analysis </li></ul><ul><li>Thermal Analysis </li></ul><ul><li>Nano-sizing </li></ul>
  9. 9. <ul><li>Formulation Development </li></ul>
  10. 10. <ul><li>Direct compression </li></ul><ul><li>Dry Granulation / Roller Compaction </li></ul><ul><li>Spray Granulation </li></ul><ul><li>Fluidized Bed Coating / Air-Suspension Coating </li></ul><ul><li>High Shear Mixing / Granulation </li></ul><ul><li>Multilayer Tableting </li></ul><ul><li>Spray Drying </li></ul><ul><li>Freeze Drying </li></ul><ul><li>Extrusion & Spheronization </li></ul><ul><li>Hot Melt Extrusion </li></ul>Development of Oral Tablets, Capsules, Dry Powders
  11. 11. Direct Compression High Shear Mixing / Granulation
  12. 12. Dry Granulation / Roller Compaction Dry Granulation / Roller Compaction
  13. 13. Fluid Bed Processing: Granulation / Drying / Coating Spray Drying
  14. 14. Nano-Suspensions
  15. 15. Analytical Services
  16. 16. <ul><li>UV-VIS Spectroscopy </li></ul><ul><li>RP-HPLC </li></ul><ul><li>SEC-HPLC </li></ul><ul><li>Ion Exchange- HPLC </li></ul><ul><li>Moisture content </li></ul><ul><li>Loss on Drying </li></ul><ul><li>pH measurement </li></ul><ul><li>Density </li></ul><ul><li>Viscosity </li></ul><ul><li>Osmolarity </li></ul>Routine QC Testing of Drugs and Pharmaceuticals
  17. 17. <ul><li>Single component analysis </li></ul><ul><li>Multi-component analysis </li></ul><ul><li>RP-HPLC and UV / PDA / RI / Fluorescence analysis </li></ul><ul><li>Chiral separations </li></ul>Analytical Method Development for Drugs and Pharmaceuticals
  18. 18. <ul><li>Accuracy </li></ul><ul><li>Precision </li></ul><ul><li>Specificity </li></ul><ul><li>LOD </li></ul><ul><li>LOQ </li></ul><ul><li>Linearity Range </li></ul><ul><li>Robustness </li></ul>Analytical Method Validation for Drugs and Pharmaceuticals
  19. 19. Dissolution Testing & Method Development
  20. 20. Stability Services
  21. 21. Stability testing for APIs, and formulations at different T/H conditions as per ICH / FDA guidelines
  22. 22. GMP Manufacturing
  23. 23. <ul><li>Capacity: </li></ul><ul><li>3000-15000 tablets / h </li></ul><ul><li>6000 capsules / day </li></ul>
  24. 24. Quality Management
  25. 25. <ul><li>Visit us at: </li></ul>Contact: [email_address] (510) 206-4667
  26. 26. Thanks!!