Norgine Limited

Hengoed, United KingdomFEI 3005202761

Norgine Limited is a drug establishment in Hengoed, United Kingdom, registered with the US FDA under FEI 3005202761. Its registered operations are: Analytical testing, Labelling, Drug manufacture, Packaging. 5 EU/UK GMP certificates are matched to this site, 4 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 testingLabellingDrug manufacturePackaging

GMP documents matched to this site (6)

DocumentAuthorityInspectionSource
Insp GMP/GDP/IMP 322/14798-0032[I]
GMP certificate
MHRA8 May 2026
within 3-year review window
MHRA-GMDP
Insp GMP/GDP/IMP 322/14798-0032[H]
GMP certificate
MHRA8 May 2026
within 3-year review window
MHRA-GMDP
UK MIA(IMP) 322 Insp IMP 322/14798-0031[I]
GMP certificate
MHRA26 Feb 2025
within 3-year review window
MHRA-GMDP
UK MIA 322 Insp GMP 322/14798-0030[H]
GMP certificate
MHRA21 Feb 2025
within 3-year review window
MHRA-GMDP
UK API 322 Insp GMP/IMP 322/14798-0027
GMP certificate
MHRA27 Feb 2019
outside 3-year review window
MHRA-GMDP
UK API 322
API registration
MHRA—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.