cGMP Manufacturing

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Bora Pharmaceutical Laboratories is a certified drug product manufacturer by Taiwan FDA, U.S. FDA and MHRA which complies with the PIC/S GMP and GDP for drug products, and the authorized operations for manufacturing and packaging non-sterile products for solid dosage form including film-coated tablet (tablets, granules, powder) and capsules.

Bora has the competence, flexibility and facilities to take on challenging projects which require custom tailored processes. With a broad range of expertise and technologies available, Bora offers support and services ranging from development and procurement to full-scale manufacturing, distribution, tech transfer, stability studies, and life cycle management.

Bora is a multipurpose 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, and Tablet Compression machine, Capsule Encapsulation Machine, Film Coater and Wurster Fluid Bed Coater. Most equipment is of standard vendor design.

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)

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

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