Suppliers / Delpharm Montréal

Delpharm Montréal

Canada 2 duplicate records merged Updated 9 July 2026

Delpharm Montréal is a finished-dose manufacturer based in Canada. It appears in 24 regulatory filings across 6 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), MINSA (CR) and NCELS (KZ). Its GMP standing is certified by ANSM (FR), US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 1 September 2023 as VAI.

0
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
24
filings across 6 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
7 of 7 confirmed
EU GMP
0 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 1 September 2023 VAI US FDA
  • 17 January 2020 NAI US FDA
  • 8 December 2017 VAI US FDA
  • 2 September 2016 NAI US FDA
  • 31 January 2014 NAI US FDA
  • 16 September 2011 VAI US FDA
  • 7 July 2009 NAI US FDA

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

Registered plants

Site FDA FEI
Quebec, United Arab Emirates Not on file
Canada, Canada 3002808099
Bretigny Sur Orge, France Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 15 None
MINSA (CR) 4 None
NCELS (KZ) 2 None
NPRA (MY) 1 None
DIGEMAPS (DO) 1 None
UZPHARM (UZ) 1 None
ANSM (FR) None 9
US FDA None 1
EMA None 1

Scale

Year Revenue Exports Destinations
2024 $21.2M Not reported Not reported

Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.

Questions about Delpharm Montréal

Does Delpharm Montréal hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Delpharm Montréal. It does have 24 filings with 6 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Delpharm Montréal FDA-registered?
One site operated by Delpharm Montréal 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 Delpharm Montréal's last inspection go?
The most recent inspection on record closed on 1 September 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 7 inspections are on file.
Where does Delpharm Montréal manufacture?
3 registered sites are on record, in United Arab Emirates, Canada and France (Quebec, Canada and Bretigny Sur Orge). Every site is listed on this page with the register it came from.
Which regulators recognise Delpharm Montréal's GMP?
Current GMP certificates are on record from ANSM (FR), US FDA and EMA. 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 1 September 2023.

Comparable suppliers

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates
Company filings
Revenue as reported