cGMP Manufacturing

Global Standard Manufacturing with Highest Quality

Complex capabilities at our core

We embrace your complex modified release and solvent processing challenges with expertise and diligence.

Commercial Manufacturing

Bora has the capabilities, flexibility and facilities to develop tailored processes that meet the requirements of your most complicated projects.

Our skilled team can manufacture the following at commercial scale:

  • Solvents
  • Oral solid and liquid dosage forms
  • Immediate and extended release
  • Core-tablets, sugar-coated tablets, film-coated tablets
  • Capsules, multi-component capsules
  • Granules, powder, liquids

All our production activities are conducted in temperature and relative humidity monitored areas. Our process rooms have individual temperature and humidity recorders installed and controlled by a Building Management System (BMS). Temperatures in manufacturing rooms are maintained thermostatically at 22 ± 3 ℃. The relative humidity is maintained at a range not more than 60% RH or 45% RH (for specific product) in each manufacturing area unless specified in Master Batch Records.

U.S. FDA, MHRA, and Taiwan FDA Certified

Bora is certified to manufacture drug products by the Taiwan FDA, U.S. FDA and the EU MHRA. We comply with the PIC/S, GMP and GDP standards for drug products and are authorized to manufacture and pack non-sterile products in solid dosage form including film-coated tablets (including granules, powder) and capsules.

Integrated Services

We have a broad range of expertise and technologies and offer support and complementary services including:

  • Development
  • Procurement
  • Distribution
  • Tech transfer and scale-up
  • Stability studies
  • Lifecycle management

Bora has a multi-purpose oral solid dose pharmaceutical manufacturing facility including process spaces for weighing, dispensing, material sizing, blending, granulating, tablet compression, coating, and encapsulation.

Manufacturing equipment includes:

  • High/low shear granulator
  • Fluid bed dryer
  • Gruenberg tray dryer
  • Through circulation dryer
  • Cone/bin blender
  • Tablet compression machine
  • Capsule encapsulation machine
  • Film coater
  • Wurster fluid bed coater

Bora's facilities are home to state-of-the-art equipment including:

  • Explosion-proof solvent system
  • Fette 2200i high speed tablet press
  • IMA adapta multi-station encapsulators
  • IMA precisa weight-checking machine
  • Glatt fluidized coating system (32" Wurster)
  • Glatt fluid bed granulator
  • Integrated extruder-spheronizer
  • USP purified water system
  • Ross mixer, Hobart mixer, Super mixer
  • Quadro Comil (194 Ultra, U-20), Fitzmill (VHP-D6A)
  • Gemco slant cone blender (30 CuFt and 60 CuFt)