BIO Asia–Taiwan 2021 亞洲生技大會

BIO Asia–Taiwan 2021 亞洲生技大會

講師

Bora Pharmaceuticals

Company Info

Name /Bora Pharmaceuticals

Address /No.1, Kedong 3rd Road,Miaoli County, 35053,Taiwan

Website /https://www.bora-corp.com/

Presenter

Name /Lonnie Barish

Title /VP, Business Development and Marketing

Email /lonnie.barish@bora-corp.com

Telephone /(Work) +1 925-380-6214

Fax /037-586558

Mobile /+1 510-305-8910

Company Type

Pharmaceutical

About the Company

Bora Pharmaceuticals is a premier international CGMP CDMO specializing in complex oral solid dosage (tablet & capsules), liquids (solutions, suspensions, & nasal sprays) and semi-solids (creams & gels) pharmaceutical Rx and OTC products for late-phase Clinical through Commercial manufacturing and packaging. Bora owns and operates three state-of-the-art CGMP manufacturing facilities (Taiwan and Canada) built to the highest international standards for manufacturing, packaging, R&D, and analytical testing. We can handle high potency compounds, solvents, flammables, and IR/SR/ER release profile products.

Our sites deliver to more than 100 markets around the world including the US/Canada, EU, Southeast Asia, Middle East, and South and Central Americas. All sites are TAA compliant. Our packaging lines are fully serialized. At Bora, reliability, integrity, and innovation are at the core of every product we touch. That is why we are dedicated to offering reliable, personal service that begins with proactive project management and technical support, which results in consistently high-quality products and complete fulfillment of your global outsourcing goals.

Brief Description of main products or services

Currently, Bora has 3 state-of-the-art cGMP manufacturing facilities for CDMO services. Our Taiwanese facilities are USFDA, MHRA, TFDA, Jordan FDA, and GCC (Gulf Cooperation Council). Our Mississauga, Canada site is approved by all major regulatory agencies including FDA, Health Canada, ANVISA, EMEA, PDMA, and the Japanese Ministry of Health. Our last FDA audits have had no findings. What makes us unique in solid dose is our ability to handle routine to complex solid dosage forms (tablet and capsules) including immediate release, controlled/extended-release, extrusion/spheronization, beads, tray drying, solvent handling, film coating, Fluidized Coating System (Wurster), and much more. What will make us unique in semi-solids and liquids is our ability to manufacture from clinical to commercial scales with high throughput and our ability to handle solvents. The Mississauga site puts a strong emphasis on employee health, safety, and well-being along with high-level environmental sustainability programs. Bora Pharmaceuticals has been dedicated to maintaining the world-class quality standard from its beginning. Advanced quality systems, including QMS, EDMS, and ERP, are effectively utilized to ensure the highest manufacturing quality. At Bora, it is our mission to provide our customers pharmaceuticals with an unparalleled quality they expect. Bora Pharmaceuticals aligns with current industry trends to ensure growth for our future and strives to deliver more products of value for our customer’s patients. 

Key capabilities:

  • Immediate Release (IR) tablets/capsules
  • Sustained, pulsed, modified, and delayed release (DR/ER) tablets/capsules
  • Aqueous and Solvent Film Coating
  • Powder, IR/ER beads, and granules filled into capsules
  • Liquids - solutions, suspensions, & nasal sprays
  • Semi-solids (creams & gels) in Aluminum tubes, laminate tubes, and sachets
  • Large Scale XP Glatt Fluid Bed (GPCG 300)
  • Extrusion/Spheronization
  • Fixed Dose Combination (FDC) Products
  • Solvent handling
  • Potent compounds, hormones, and Steroids
  • Formulation, process, and analytical development
  • Fully serialized packaging
  • Stability testing and storage

Contact Person

Name /Wayne Hsiao

Email /wayne.hsiao@bora-corp.com

Phone /037-586268 ext. 1311