Is Duchesnay Inc. FDA approved?

Duchesnay Inc. holds 1 FDA-registered establishment in Canada. 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 Duchesnay Inc.'s drugs manufactured?

The FDA register lists Blainville. Registered operations: labelling, finished drug manufacture, packaging.

What drugs does Duchesnay Inc. make?

3 products are listed under Duchesnay Inc. in the openFDA NDC Directory, most often as tablet, delayed release; tablet, extended release; tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Duchesnay Inc.

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

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Registered sites: 1
Active NDC listings: 3
Live patents: 5
Countries: 1
Base: Canada

Authorisation

Registered operations

Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Duchesnay Inc.	950 boul Mich�le-Bohec, Blainville, QC J7C 5E2, Canada (CAN)	Labelling, Finished drug manufacture, Packaging	3009166000240538306

Catalogue

Drug listings by form and route

3 active NDC listings: 3 human prescription drug. By marketing category: NDA 3.

Dosage form	NDCs
tablet, delayed release	1
tablet, extended release	1
tablet, film coated	1

Route	NDCs
oral	3

Labeller name on the listing	NDCs
duchesnay usa, inc.	3

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
8642079	OSPHENAospemifene	product	Jul 2028
9089489	BONJESTAdoxylamine succinate; pyridoxine hydrochloride	product	Feb 2033
9375404	BONJESTAdoxylamine succinate; pyridoxine hydrochloride	product	Feb 2033
9526703	BONJESTAdoxylamine succinate; pyridoxine hydrochloride	product	Feb 2033
9937132	BONJESTAdoxylamine succinate; pyridoxine hydrochloride	product	Feb 2033

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
BONJESTA	doxylamine succinate and pyridoxine hydrochloride	tablet, extended release, oral	55494-120NDA
DICLEGIS	doxylamine succinate and pyridoxine hydrochloride	tablet, delayed release, oral	55494-100NDA
Osphena	Ospemifene	tablet, film coated, oral	55494-580NDA

Neighbours

Registered in the same town

Neopharm Labs Inc.BLAINVILLE, CAN

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Enquiry

Common questions

Is Duchesnay Inc. FDA approved?: Duchesnay Inc. holds 1 FDA-registered establishment in Canada. 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 Duchesnay Inc.'s drugs manufactured?: The FDA register lists Blainville. Registered operations: labelling, finished drug manufacture, packaging.
What drugs does Duchesnay Inc. make?: 3 products are listed under Duchesnay Inc. in the openFDA NDC Directory, most often as tablet, delayed release; tablet, extended release; 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.