Pharmaceutical Contract Manufacturing and Packaging Services

High Quality

1. Quality Standard Products

USFDA, MHRA, ANVISA, TFDA, Health Canada, Japan FDA, Russian Ministry, Turkish MoH, Korean FDA, PIC/S, TFDA, Jordan FDA, and GCC regulatory inspections and filings GMP certified for sales to over 100 countries including: US, EU, N. and S. America, Southeast and Southwest Asia, Middle East, and Central America

Teamwork

2. Customer Oriented

Reliable, Flexible, and Customizable Solutions.

Robust Product Knowledge

3. Robust Product Knowledge & Skilled Scientists

Manufacturing over 90 SKUs for global partners to over 100 countries including: US, EU, N. and S. America, Southeast and Southwest Asia, Middle East, and Central America

Speed

4. Meet Your Timelines

Systemized lifecycle management from early development to global commercialization. Bora strives andachieves execution on client timelines with speed and flexibility (>96%).

World Class Large Scale Manufacturing

5. World-Class Manufacturing (Small, Medium, and Large-Scale)

239,853 m2 of manufacturing space with state-of-the-art equipments including:

  • Automatic solvent preparation system
  • High-speed Fette tablet press
  • IMA Adapta Multi-component encapsulators
  • Glatt fluidized Coating System
  • Glatt Fluid-bed granulator
  • Gerties MINI-PACTOR® roller compactor
  • Integrated circle feeder-extruder-spheronizer
Solvent Manufacturing Capabilities

6. Solvent Manufacturing Capabilities

Explosion-proof (XP) system, Automation controls, High-volume solvent preparation, film coating, and manufacturing..

Oral Solid and Liquid Dosage Forms

7. Oral Solid, Semi-solids, and Liquid Dosage Forms

  • Tablets (Bilayer, Sugar-coated, Film-coated)
  • Capsules & Multi-component Capsules
  • Granules, Powder
  • Immediate, Delayed, and Extended-release
  • Liquids (intranasal sprays, liquids and suspensions)
  • Semi-solids ( Creams, gels, ointments)
  • Fixed-dose combination products
Packaging Capabilities

8. Packaging Capabilities

  • Cap/Tab bottle packs
  • Blister packs
  • Granule and semi-solid sachets
  • Liquid bottle packs
  • Semi-solid tubes (aluminum and laminate)
  • Pillow blistering pack
Serialization Capabilities

9. Serialization

 

Our Services

Commercial Manufacturing

CLINICAL AND COMMERCIAL MANUFACTURING

  • Oral Solid, Semi-solid, and Liquid Dosage Forms
  • Solvent manufacturing processing
  • Immediate, Delayed, and Extended Release
  • Core-tablets, Sugar-coated Tablets, Film-coated Tablets (including solvent coating)
  • Capsules, Multi-component Capsules
  • Granules, Liquids
Pharmaceutical Development

Pharmaceutical Development

  • Formulation Development: Liquid Dosage Form, Semi-solid, and Solid Dosage Form (immediate and controlled released)
  • Analytical Method Development, Transfer, Verification, and Validation
  • Process Study and Scale-Up
Packaging Serialization

Packaging & Serialization

  • Bottle Packaging: Capsule, Tablets, Liquids
  • Blister Packaging: Blister pillow packs, blister pack
  • Semi-solid Packaging: aluminum and laminate tubes
  • Nasal Sprays Packaging
  • Sachets: Granules and semi-solid
Microbiology Testing Services

Analytical & Microbiology Testing Services

  • Raw materials and Finished products testing
  • Method verification, validation, transfer
  • Analytical Techniques
    • Wet Chemistry
    • Liquid Chromatography (LC/UPLC)
    • Gas Chromatography (GC)
    • Ion Chromatography (IC)
    • Capillary Electrophoresis Chromatography (CE)
    • Mass Spectrometry (MS)
    • Spectrophotometry (UV, NIR, IR, Raman)
    • Laser Particle Sizer
    • Volumetric/ Coluometric Titration
    • Dissolution
    • Disintegration
    • Total Organic Carbon (TOC)
    • Physical property (Hardness, Friability)
    • Sterile Operation
    • Microorganism Identification
Distribution

Regulatory Affairs

  • USFDA, MHRA, ANVISA, TFDA, Health Canada, Japan FDA, Russian Ministry, Turkish MoH, Korean FDA, PIC/S, TFDA, Jordan FDA, and GCC regulatory inspections and filings

Quality without compromise

BORA SHIPPING LOCATIONS

Approved by USFDA, MHRA, Health Canada, ANVISA,, Japan FDA, Russian Ministry, Turkish MoH, Korean FDA, PIC/S, GMP, TFDA, Jordan FDA, and GCC (Gulf Cooperation Council)

GMP certified for sales to over 100 countries including US, Canada, EU, Southeast and Southwest Asia, Middle east, and Central America

Americas:
USA, Canada, Central and South America.

Europe:
UK, Central and EEU

Middle East

Russian Federation

Australia/New Zealand

Asia:
China, Singapore, Hong Kong, Indonesia, Malaysia, Philippines, Thailand, India, and & Taiwan

Worldwide Partnerships

Dedication to strict quality standards, reliability, and customer service has allowed Bora to become a reliable CMO and CDMO partner for many multinational companies.

brands

Worldclass Facilities

Bora Jhunan Plant
  • 36,133m2 (316,000 ft2)
  • USFDA, MHRA, and the TFDA-approved
  • 2 billion units of solid-dosage form (IR and ER)
  • Bottle Packaging
  • Serialization

State-of-the-art Equipment

Pharma Equipment Manufacturing

Manufacturing

  • Explosion-proof Solvent System
  • USP Purified Water System
  • Ross Mixer, Hobart Mixer, Super Mixer
  • Integrated Extruder-Spheronizer
  • Glatt Fluid Bed Granulator
  • Quadro Comil (194 Ultra, U-20), Fitzmill (VHP-D6A)
  • Gemco Slant Cone Blender (30 CuFt and 60 CuFt)
  • Fette 2200i Tablet Press
  • IMA Adapta Encapsulator
  • Glatt Fluidized Coating System (32" Wurster)
  • Sugar Coater
  • Beco 3000L
  • Lee 3800L
  • MMU 500Kg
  • Courtoy R292F Tablet Press
  • Microwave Granulator VMA 600 and Dryer
Pharma Equipment

Analytical & Microbiology Laboratory

  • Wet Chemistry
  • Liquid Chromatography (LC/UPLC)
  • Gas Chromatography (GC)
  • Ion Chromatography (IC)
  • Capillary Electrophoresis Chromatography (CE)
  • Mass Spectrometry (MS)
  • Spectrophotometry (UV, NIR, IR, Raman)
  • Malvern mastersizer 2000 Laser Diffraction
  • Volumetric/ Coulometric Titration
  • Dissolution
  • Disintegration
  • Total Organic Carbon (TOC)
  • Physical property (Hardness, Friability)
  • Sterile Operation
  • Microbial Limits Testing USP

Process

 

Project Evaluation

 

Proposal & Agreement

 

Technology Transfer

 

Pivotal Batch Manufacturing

 

Scale-Up & Process Manufacturing

 

Commercial Manufacturing

About Bora Group

Bora Pharmaceuticals is one of the premier pharmaceutical companies in Taiwan. We are one of the few companies that covers the entire pharmaceutical supply chain from research and development all the way to sales and distribution. We provide outsourced R&D and toll manufacturing services for Taiwan domestic and global pharmaceutical companies around the world. With Bora's USFDA, MHRA, and PIC/S certified facilities, we produce pharmaceuticals at the highest world standards for sales to over 100 countries worldwide.  Our mission is to push the boundaries of product innovation, while maintaining the highest quality standards, in order to be the premier outsourcing pharmaceutical company to supply your products worldwide. 
 

Bora Pharmaceuticals has 3 cGMP manufacturing facilities located in Canada and Taiwan. Our facilities are built with the highest international standards of manufacturing, packaging, pharmaceutical R&D, and analytical testing. Mississauga plant is certified by USFDA, Health Canada, EMA, PMDA and many others for sales to over 100 countries. Zhunan plant is USFDA, EU MHRA and TFDA-approved for sales to Taiwan, US, EU countries. The Tainan facility is PIC/S GMP-certified by TFDA, Jordan FDA, and GCC (Gulf Cooperation Council) for sales to 16 countries covering Southeast Asia, and Southwest Asia, Middle East, and Central America.

Contact Bora CDMO

Contact Bora today for CMO/CDMO/CPO services to accelerate
your pharmaceutical manufacturing for US, EU and global markets

Bora Pharmaceutical
Laboratories Inc.

1000 N. West Street,
Suite 1200, Wilmington,
DE 19801 USA

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Phone:
1-866-6PHARMA
(1-866-674-2762)