Is Medicure International Inc FDA approved?

Medicure International Inc holds 1 FDA-registered establishment in BRB. 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 Medicure International Inc's drugs manufactured?

The FDA register lists Holetown. Registered operations: finished drug manufacture.

What drugs does Medicure International Inc make?

6 products are listed under Medicure International Inc in the openFDA NDC Directory, most often as injection, solution; tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Medicure International Inc

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

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Registered sites: 1
Active NDC listings: 6
Live patents: 3
Countries: 1
Base: BRB

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Medicure International Inc.Registrant: Medicure International Inc	C/O: JLT Management (Barbados) Ltd 1st. Floor Limegrove Centre, Holetown, St. James 24016, Barbados (BRB)	Finished drug manufacture	3005981418860240324

Catalogue

Drug listings by form and route

6 active NDC listings: 6 human prescription drug. By marketing category: NDA 6.

Dosage form	NDCs
injection, solution	4
tablet, film coated	2

Route	NDCs
intravenous	4
oral	2

Labeller name on the listing	NDCs
medicure international inc	6

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
8829186	ZYPITAMAGpitavastatin magnesium	substance, product	Jan 2031

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
AGGRASTAT	TIROFIBAN	injection, solution, intravenous	25208-001NDA
AGGRASTAT	TIROFIBAN	injection, solution, intravenous	25208-002NDA
AGGRASTAT	TIROFIBAN	injection, solution, intravenous	25208-901NDA
AGGRASTAT	TIROFIBAN	injection, solution, intravenous	25208-902NDA
ZYPITAMAG	Pitavastatin Magnesium	tablet, film coated, oral	25208-201NDA
ZYPITAMAG	Pitavastatin Magnesium	tablet, film coated, oral	25208-202NDA

Enquiry

Common questions

Is Medicure International Inc FDA approved?: Medicure International Inc holds 1 FDA-registered establishment in BRB. 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 Medicure International Inc's drugs manufactured?: The FDA register lists Holetown. Registered operations: finished drug manufacture.
What drugs does Medicure International Inc make?: 6 products are listed under Medicure International Inc in the openFDA NDC Directory, most often as injection, solution; tablet, film coated. 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.