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, ointments & gels) pharmaceutical Rx and OTC products for late-phase Clinical through Commercial manufacturing and packaging. We Bora can handle high potency compounds, solvents, flammables, and IR/SR/ER release profile products.
Bora Biologics has a platform approach to developing biologics which allows Bora to perform all activities needed to transform biologics from concept to clinical product in-house. Bora Biologics provides expertise in phase-appropriate, extensive physio-chemical and functional assay (particularly Bioassays) packages to support cell line, formulation or process development, comparability studies, reference material qualifications and full analytical characterization. Bora has designed a robust proprietary cell-line platform to efficiently and successfully generate clinical trial materials for our customers.
Bora owns and operates six state-of-the-art cGMP manufacturing facilities (Taiwan and Canada) built to the highest international standards for manufacturing, packaging, and analytical testing.
Our Taiwanese facilities are USFDA, MHRA, TFDA, Jordan FDA, and GCC (Gulf Cooperation Council) inspected. Our Mississauga, Our Canada site is approved by all major regulatory agencies including USFDA, Health Canada, ANVISA, EMA, PDMA, and the Japanese Ministry of Health. Our last USFDA audits have had no findings.
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. Our sites have over a 98% on-time delivery record!
Bora Pharmaceuticals has an extremely solid financial foundation and experienced management team, with over 20+ years working in the pharmaceutical industry.
Quality
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.
