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.

Clinical and 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:

  • Oral solid, semi-solid, and liquid dosage forms
  • Work with solvents
  • Immediate and extended release
  • Core-tablets, sugar-coated tablets, aqueous and solvent film-coated tablets
  • Capsules, multi-component capsules

Manufacturing in temperature and relative humidity monitored and controlled 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 a specific product) in each manufacturing area unless specified in Master Batch Records.

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

Taiwan sites are USFDA, MHRA, and Taiwan FDA inspected.
Canadian sites are USFDA, MHRA, ANVISA, TFDA, Health Canada, Japan FDA, Russian Ministry, Turkish MoH, and Korean FDA inspected. 
 


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 multi-purpose,  oral solid dose, semi-solid, and not-sterile liquid pharmaceutical manufacturing facilities including process spaces for weighing, dispensing, material sizing, blending, granulating, tablet compression, coating, and encapsulation.

Manufacturing equipment includes:

  • High/low shear granulators
  • Fluid bed dryer
  • Roller compactor
  • Gruenberg tray dryer
  • Circulation dryer
  • Cone/bin blenders
  • Film coaters
  • Wurster fluid bed coaters

Bora's facilities are home to state-of-the-art equipment. Here is a listing of some equipment: 

  • 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)