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World Class FDA & MHRA Approved Facilities

 
 
 

Zhunan Facility

  • Learn More
  • Overview
  • Key capabilities
  • Key equipment
  • Regulatory compliance

Overview

Bora's Zhunan facility is one of the largest USFDA and MHRA approved pharmaceutical production facilities in Taiwan. Our 316,000 ft2(36,133m2) plant is a fully dedicated CMO site which provides cGMP compliant multipurpose manufacturing of oral solid doses as well as packaging services with the capabilities to produce for the US, Europe, and Taiwan markets.

Bora Facility
QC Dissolution
Bora Zhunan Reception
Bora Facilities

Key capabilities

agilent head space 7890a
agilent head space 7890aCapsule Machine

Our Zhunan site is capable of handling high-volume or small batch manufacturing of various solid dosage forms and bottle packaging.

Immediate release and controlled release technologies
Oral solid dosage forms
  • Core and film-coated tablets
  • Capsules and multi-component capsules
  • Granules, powder
Analytical and microbiology laboratory
Bottle packaging
L4 serialization solution provider

The facility also houses laboratories for

Analytical method development and validation
Method transfers
QC release and stability testing
Microbiology testing

Key equipment

agilent head space 7890a
agilent head space 7890aCapsule Machine
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 and Wurster fluid bed coater

Regulatory compliance

Bora holds an outstanding track record when it comes to regulatory inspections.

  • FDA approved since June 2009; 6 FDA inspections and all received zero 483 observations and complete compliant results (last inspection May 2019).
  • MHRA approved since July 2015; Bora has had 2 MHRA inspections and both received compliant results (last inspection July 2015)
  • TFDA approved since March 2010; Bora has had 5 TFDA inspections and all received compliant results (last inspection May 2017)
Inspections
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In This Section:
  • Zhunan Facility
  • Tainan Facility

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