Zhunan Facility

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.

Key capabilities

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

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)

Bora Pharmaceuticals

World Class FDA & MHRA Approved Facilities