Is Norbrook Laboratories Limited FDA approved?

Norbrook Laboratories Limited holds 2 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Norbrook Laboratories Limited's drugs manufactured?

At registered sites in the United Kingdom, Ireland. The FDA register lists Newry; MONAGHAN. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

Norbrook Laboratories Limited

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 2
Active NDC listings: 0
Live patents: 0
Countries: 2
Base: United Kingdom

Authorisation

Registered operations

Analytical testing2Active ingredient (API) manufacture1Labelling2Finished drug manufacture2Packaging2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Norbrook Laboratories Limited	Carnbane Industrial Estate, Newry, County Down BT35 6QQ, United Kingdom (GBR)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3005587188211218325
NORBROOK MANUFACTURING LIMITEDRegistrant: Norbrook Laboratories Limited	Rossmore Industrial Estate, MONAGHAN, CO. MONAGHAN , Ireland (IRL)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3009133918986217040

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Common questions

Is Norbrook Laboratories Limited FDA approved?: Norbrook Laboratories Limited holds 2 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Norbrook Laboratories Limited's drugs manufactured?: At registered sites in the United Kingdom, Ireland. The FDA register lists Newry; MONAGHAN. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.