FUJIFILM Diosynth Biotechnologies U.S.A., Inc

Research Triangle Park, United StatesFEI 3000718852API manufacture registered

FUJIFILM Diosynth Biotechnologies U.S.A., Inc is a drug establishment in Research Triangle Park, United States, registered with the US FDA under FEI 3000718852. Its registered operations are: Analytical testing, API manufacture. 1 EU/UK GMP certificate is matched to this site.

Sources: FDA Drug Establishments Current Registration Site (checked 2 Nov 2026); EudraGMDP; MHRA GMDP. Methodology

Registered operations

Business operations this establishment declares in its FDA registration. Registration is not an approval and says nothing about EU or UK GMP status.

Analytical testingAPI manufacture

GMP documents matched to this site (1)

DocumentAuthorityInspectionSource
UK GMP 45282 Insp GMP 45282/13009579-0001[H]
GMP certificate
MHRA10 Aug 2015
outside 3-year review window
MHRA-GMDP

A GMP document is matched to this site when its address names the site's street and its city or postcode. In our latest internal review 59 of 60 sampled matches were the right site (not yet independently reviewed; measured match quality). Check the certificate's own address before relying on it. The three-year review window is the EMA guideline default after an inspection, not an official expiry date.

What this page does not show

  • Which substances are made here: DMFs and CEPs are filed by organisations, not sites, so we do not link substances to this site.
  • Capacity, scale, price or current availability: no regulator publishes these.
  • FDA inspection classifications for this site, which are not yet linked.