Suppliers / Laboratoire Atlas

Laboratoire Atlas

Canada Updated 9 July 2026

Laboratoire Atlas is a finished-dose manufacturer based in Canada. It appears in 24 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with Health Canada and ARCSA (EC). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 7 March 2025 as VAI.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
24
filings across 2 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

  • 7 March 2025 VAI US FDA
  • 26 April 2019 VAI US FDA
  • 11 May 2016 VAI US FDA
  • 14 January 2011 VAI US FDA

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

Registered plants

Site FDA FEI
Canada, Canada 3007083710

Filings and GMP by regulator

Regulator Filings GMP certificates
Health Canada 23 None
ARCSA (EC) 1 None
US FDA None 1

Questions about Laboratoire Atlas

Does Laboratoire Atlas hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Laboratoire Atlas. It does have 24 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Laboratoire Atlas FDA-registered?
One site operated by Laboratoire Atlas 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 Laboratoire Atlas's last inspection go?
The most recent inspection on record closed on 7 March 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Laboratoire Atlas manufacture?
1 registered site is on record, in Canada (Canada). Every site is listed on this page with the register it came from.
Which regulators recognise Laboratoire Atlas's GMP?
Current GMP certificates are on record from US FDA. 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 7 March 2025.

Comparable suppliers

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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