Suppliers / Novocol Pharmaceutical Of Canada

Novocol Pharmaceutical Of Canada

Canada Updated 9 July 2026

Novocol Pharmaceutical Of Canada is a finished-dose manufacturer based in Canada. It appears in 20 regulatory filings across 6 regulators, without an active US DMF or CEP on file. Its filings concentrate with Health Canada, EDE (AE) and SFDA (Saudi Arabia). Its GMP standing is certified by ANVISA (Brazil), MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 3 May 2024 as VAI.

0
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
20
filings across 6 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 3 May 2024 VAI US FDA
  • 30 January 2020 NAI US FDA
  • 21 June 2019 NAI US FDA
  • 18 June 2019 VAI US FDA
  • 26 July 2017 VAI US FDA
  • 16 May 2017 VAI US FDA
  • 11 August 2015 VAI US FDA
  • 11 November 2014 VAI US FDA

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

Registered plants

Site FDA FEI
Cambridge, United Arab Emirates Not on file
ONTARIO, Canada Not on file
Canada, Canada 3002807757

Filings and GMP by regulator

Regulator Filings GMP certificates
Health Canada 9 None
EDE (AE) 3 None
SFDA (Saudi Arabia) 3 None
RCETH (BY) 2 None
NPRA (MY) 2 None
EDA (EG) 1 None
ANVISA (Brazil) None 2
MFDS (Korea) None 2
US FDA None 1

Questions about Novocol Pharmaceutical Of Canada

Does Novocol Pharmaceutical Of Canada hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Novocol Pharmaceutical Of Canada. It does have 20 filings with 6 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Novocol Pharmaceutical Of Canada FDA-registered?
One site operated by Novocol Pharmaceutical Of Canada 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 Novocol Pharmaceutical Of Canada's last inspection go?
The most recent inspection on record closed on 3 May 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Novocol Pharmaceutical Of Canada manufacture?
3 registered sites are on record, in United Arab Emirates and Canada (Cambridge, Ontario and Canada). Every site is listed on this page with the register it came from.
Which regulators recognise Novocol Pharmaceutical Of Canada's GMP?
Current GMP certificates are on record from ANVISA (Brazil), MFDS (Korea) and 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 3 May 2024.

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