Contract manufacturing

Fujirebio is an industry leader in contract manufacturing for the global diagnostics market. Our state-of-the art GMP manufacturing sites are ISO 13485 certified and strategically located around the world to consistently meet our partners’ supply and demand requirements. 

Fujirebio offers two types of contract manufacturing services: contract product development inclusive of contract manufacturing, and manufacturing transfer. 

Our contract manufacturing services seamlessly flow from the contract product development teams to commercial supply. In addition, our partners have the option to transfer production of existing or new products to any of our global sites. 

Our design control and robust process validation processes ensure successful and efficient implementation. 

Fujirebio contract manufacturing covers a wide range of technologies such as EIA, CLIA (CLEIA), PA, and molecular. 

Our services include, but are not limited to, antibodies, instrument consumables, assay intermediates (concentrates and bulks), filled assay components (reagents, calibrators, controls, buffers), and finished products.

Finished products are inclusive of fully labeled and packaged products that meet worldwide regulatory and customer needs.
 

Back to Contract Development/Manufacturing Organization (CDMO)