Is Rosemont Pharmaceuticals Limited FDA approved?

Rosemont Pharmaceuticals Limited holds 1 FDA-registered establishment in the United Kingdom. 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 Rosemont Pharmaceuticals Limited's drugs manufactured?

The FDA register lists Leeds. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does Rosemont Pharmaceuticals Limited make?

5 products are listed under Rosemont Pharmaceuticals Limited in the openFDA NDC Directory, most often as solution; suspension; tablet, extended release. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Rosemont Pharmaceuticals Limited

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

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Registered sites: 1
Active NDC listings: 4
Labeller names: 2
Live patents: 2
Countries: 1
Base: United Kingdom

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Rosemont Pharmaceuticals Limited	Rosemont House Yorkdale Industrial Park, Braithwaite Street, Leeds, West Yorkshire LS11 9XE, United Kingdom (GBR)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3002442738212997852

Catalogue

Drug listings by form and route

4 active NDC listings: 4 human prescription drug. By marketing category: NDA 4.

Dosage form	NDCs
solution	2
suspension	1
tablet, extended release	1

Route	NDCs
oral	4

Labeller name on the listing	NDCs
rosemont pharmaceuticals llc	3
rosemont pharmaceuticals, llc	1

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
12343338	VOSTALLYramipril	product	Aug 2039
12390439	ATMEKSImethocarbamol	product	Oct 2044

Catalogue

Marketed products

Showing 4 of 5.

Brand	Generic name	Form / route	NDC
ATMEKSI	methocarbamol	suspension, oral	69528-701NDA
Nexiclon XR	Clonidine	tablet, extended release, oral	71511-503NDA
OZOBAX DS	Baclofen	solution, oral	69528-302NDA
Ontralfy	Tizanidine Hydrochloride	solution, oral	69528-310NDA

Neighbours

Registered in the same town

Reed BaileyLeeds, GBR

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Enquiry

Common questions

Is Rosemont Pharmaceuticals Limited FDA approved?: Rosemont Pharmaceuticals Limited holds 1 FDA-registered establishment in the United Kingdom. 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 Rosemont Pharmaceuticals Limited's drugs manufactured?: The FDA register lists Leeds. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Rosemont Pharmaceuticals Limited make?: 5 products are listed under Rosemont Pharmaceuticals Limited in the openFDA NDC Directory, most often as solution; suspension; tablet, extended release. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

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.