CELGENE CORPORATION

SUMMIT, United StatesFEI 3004991673API manufacture registered

CELGENE CORPORATION is a drug establishment in SUMMIT, United States, registered with the US FDA under FEI 3004991673. Its registered operations are: Analytical testing, API manufacture, Labelling, Drug manufacture, Packaging. 3 EU/UK GMP certificates are matched to this site, 1 inspected within the last three years.

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 manufactureLabellingDrug manufacturePackaging

GMP documents matched to this site (3)

DocumentAuthorityInspectionSource
NL/H 25/2057053
GMP certificate
Competent authority of Netherlands25 Sept 2025
within 3-year review window
EudraGMDP
NL/H 23/2048089
GMP certificate
Competent authority of Netherlands6 Apr 2023
outside 3-year review window
EudraGMDP
UK GMP 14758 Insp GMP 14758/5575-0003[H]
GMP certificate
MHRA21 Aug 2014
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.