Suppliers / Duchesnay

Duchesnay

Canada 84 employees 2 duplicate records merged Updated 9 July 2026

Duchesnay is a finished-dose manufacturer based in Canada. It appears in 32 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with Health Canada, US FDA and ARCSA (EC). Its GMP standing is certified by MFDS (Korea), US FDA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 27 October 2023 as VAI.

0
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
32
filings across 5 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 27 October 2023 VAI US FDA
  • 29 March 2019 VAI US FDA
  • 25 February 2016 NAI US FDA
  • 22 August 2013 NAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
BLAINVILLE, United Arab Emirates Not on file
QUEBEC, Canada Not on file
Canada, Canada 3009166000

Filings and GMP by regulator

Regulator Filings GMP certificates
Health Canada 27 None
US FDA 2 1
ARCSA (EC) 1 None
INVIMA (CO) 1 None
EMA 1 None
MFDS (Korea) None 2
ANVISA (Brazil) None 1

Questions about Duchesnay

Does Duchesnay hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Duchesnay. It does have 32 filings with 5 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Duchesnay FDA-registered?
One site operated by Duchesnay 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.
How did Duchesnay's last inspection go?
The most recent inspection on record closed on 27 October 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Duchesnay manufacture?
3 registered sites are on record, in United Arab Emirates and Canada (Blainville, Quebec and Canada). Every site is listed on this page with the register it came from.
Which regulators recognise Duchesnay's GMP?
Current GMP certificates are on record from MFDS (Korea), US FDA and ANVISA (Brazil). 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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Open risk flags

  • The most recent inspection outcome was VAI, on 27 October 2023.

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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