Oral Dosage

Manufacturing

Stable Capacity & Technology-Driven Processes

Utilizing best-in-class technologies and processes, our oral dosage specialists deliver innovative compounds from the laboratory onto the assembly line and to the public in safe, effective forms with the utmost precision and efficiency.


Quick facts:

  • PIC/S GMP, EU GMP, Taiwan and US FDA-certified facility in Yunlin, Taiwan
  • Specializes in complex modified release drugs
  • 162,532 square feet
  • 16 production suites
  • 30 cleanrooms
  • 4 packaging lines
  • Trade Agreement Act compliance meets U.S. requirements for trade with the U.S. government

 

Formulation development capabilities include working with:

  • Potent APIs
  • Poorly soluble APIs
  • Controlled and modified release technologies
  • Multi-particulate drug delivery systems
  • Taste-making and pediatric dosage forms
  • Bioavailability enhancements

Specialty formulation technologies:

  • Multi-Phasic Release Technology (MPRT)
  • Multi-Day Transdermal Drug Delivery (MTDD)
  • Zero Order Release [Osmotic-controlled release oral delivery system (OROS) and multiple  pellets in capsule (PROS)]

 

Key formulation techniques:

  • Triple fill capacity - hard capsule
  • Liquid/semi-solid fill - hard capsule
  • High shear wet granulation
  • Bilayer tablet compression
  • Cosmetic and functional Capsule/Tablet coating
  • Fluid bed granulation
  • Drug layering and polymer coating onto pellets with Wurster Process
  • Tablet laser drilling

Best-in-Class Services At-a-Glance

  • Manufacturing capacity: 
    - 400 mm tablets
    - 230 mm capsules
    - 45 mm hot melt capsules
  • Efficient scale-ups for each stage:
    - Batch sizes: 200g-1000kg
    - 2 unique production areas (preclinical/clinical, commercial)
  • State-of-the-art equipment:
    - Bosch,  Fette, Glatt, Qualicaps, Servolift