Zhunan Facility

01.Overview

Bora Zhunan Production Facility

 

Bora’s Zhunan facility is one of the largest US FDA and MHRA approved pharmaceutical production facilities in Taiwan.

Our 316,000 sq. ft. (36,133m2) plant is a fully dedicated CMO site which provides cGMP compliant manufacturing and packaging services for the US, European and Taiwanese markets.

 

We have a proven track record of high quality, consistent output and invest in on-going equipment maintenance. The facility has passed multiple inspections from the US FDA, MHRA, and the TFDA. Our highly trained staff ensure that quality is maintained throughout the production process and data integrity is upheld to the highest standards.

Temperature & Humidity Controlled Warehouse
Disintegration Pharmatron

With our proven track record of high quality, consistent output, and on-going equipment maintenance, we have been passed multiple inspections from the USFDA, MHRA, and the TFDA. In additional, our highly trained staff insures that quality is maintained throughout the production process and data integrity is upheld to the highest standards.

Fette 2200i Tablet Press

Bora Zhunan is capable of handling high-volume or small batch manufacturing of various solid dosage forms and bottle packaging. The facility includes also laboratories for analytical method development and validation, method transfers, QC release and stability testing as well as microbiology testing.

Manufacturing Capabilities

 

Our Zhunan site has the capabilities to handle high-volume or small batch manufacturing of various solid dosage forms including:

 

    • Immediate release and controlled release technologies
    • Oral solid dosage forms:
      .Core and film-coated tablets
      .Capsules & multi-component capsules
      .Granules
      .Powders
    •  
Glatt Machine

Packaging services

Our manufacturing capabilities are complemented with high quality bottle packing and level 4 serialization services.

Analytical services

We offer analytical method development and validation, method transfers, QC release and stability testing as well as microbiology testing from comprehensively equipped laboratories at our Zhunan site.

02.Regulatory Compliance

We have an outstanding regulatory track record.

  • FDA approved since June 2009 (zero 483 observations since 2012)
  • TFDA approved since March 2010
  • MHRA approved since July 2015