Suppliers / Norbrook Laboratories

Norbrook Laboratories

United Kingdom Updated 9 July 2026

Norbrook Laboratories is an API and finished-dose manufacturer based in United Kingdom. It holds 4 valid CEPs across a filed portfolio of 3 molecules. Its filings concentrate with MPA (SE), Health Canada and URPL (PL). Its GMP standing is certified by MHRA (UK).

0
active US DMFs
4
valid CEPs
3
registered plants 1 with an FDA FEI number
198
filings across 6 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026.

Registered plants

Site FDA FEI
NEWRY, United Kingdom Not on file
United Kingdom, United Kingdom 3005587188
Newry, Ireland Not on file

What they file, and where

Molecule Regulators Docs
Oxytetracycline EDQM 2
Flunixin Meglumine For Veterinary Use EDQM 1
Meloxicam EDQM 1

Also appears on these molecule pages

Flunixin Meglumine For Veterinary Use API Meloxicam API Methimazole finished dose Oxytetracycline API

Filings and GMP by regulator

Regulator Filings GMP certificates
MPA (SE) 89 None
Health Canada 70 None
URPL (PL) 31 None
NPRA (MY) 5 None
EMA 2 None
DKMA (DK) 1 None
MHRA (UK) None 2

Questions about Norbrook Laboratories

Does Norbrook Laboratories hold a US DMF or a CEP?
Norbrook Laboratories holds 4 valid CEPs. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Norbrook Laboratories FDA-registered?
One site operated by Norbrook Laboratories carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
Where does Norbrook Laboratories manufacture?
3 registered sites are on record, in United Kingdom and Ireland (Newry, United Kingdom and Newry). Every site is listed on this page with the register it came from.
What does Norbrook Laboratories make?
3 molecules are on record against Norbrook Laboratories, including Oxytetracycline, Flunixin Meglumine For Veterinary Use and Meloxicam. Each links through to that molecule's full manufacturer list.
Which regulators recognise Norbrook Laboratories's GMP?
Current GMP certificates are on record from MHRA (UK). GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates