About Bora Pharmaceuticals

Quality with flexibility. Your success is our promise.

 

01.Overview

Bora Pharmaceuticals is a premier international cGMP CDMO specializing in complex oral solid dosage (tablet & capsules), liquids (solutions, suspensions, and nasal sprays), and semi-solids (cream & 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 Taiwanese facilities are USFDA, MHRA, TFDA, Jordan FDA, and GCC (Gulf Cooperation Council) inspected.  Our Mississauga, Canada site is approved by all major regulatory agencies including USFDA, Health Canada, ANVISA, EMEA, PDMA, and the Japanese Ministry of Health.  Our last FDA audits have had no 483s.

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.

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.

02.Quality

Bora Pharmaceuticals has been dedicated to maintaining the world-class quality standard from its beginning. Advanced quality systems, including ZenQMS, EDMS, and ERP, are effectively utilized to ensure the highest manufacturing quality. At Bora, it is our mission to provide our customers pharmaceuticals with the unparalleled quality they expect.

 

Quality Control