Suppliers / Delmar Chemicals

Delmar Chemicals

Canada Updated 9 July 2026

Delmar Chemicals is an API manufacturer based in Canada. It holds 30 active US drug master files across a filed portfolio of 15 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 18 September 2025 as NAI.

30
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 18 September 2025 NAI US FDA
  • 28 February 2020 NAI US FDA
  • 4 May 2018 NAI US FDA
  • 29 January 2016 VAI US FDA
  • 1 November 2012 NAI US FDA
  • 8 April 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
Canada, Canada 3002806795

What they file, and where

Molecule Regulators Docs
Apixaban US FDA 2
Eslicarbazepine Acetate US FDA 2
Esmolol US FDA 2
Fluorescein US FDA 2
Lapatinib US FDA 2
Methazolamide US FDA 2
Mirabegron US FDA 2
Montelukast US FDA 2
Pentamidine US FDA 2
Pyrazinamide US FDA 2
Show all 15 molecules on file
Rosuvastatin US FDA 2
Solifenacin Succinate US FDA 2
Sorafenib US FDA 2
Succinylcholine US FDA 2
Tofacitinib US FDA 2

Also appears on these molecule pages

Eslicarbazepine API Esmolol API Fluorescein API Lapatinib API Montelukast API Pyrazinamide API Solifenacin API Sorafenib API Succinylcholine API Tofacitinib API Rosuvastatin API Mirabegron API
Show 1 more molecule pages
Apixaban API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 1 None
US FDA None 1

Questions about Delmar Chemicals

Does Delmar Chemicals hold a US DMF or a CEP?
Delmar Chemicals holds 30 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Delmar Chemicals FDA-registered?
One site operated by Delmar Chemicals 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 Delmar Chemicals's last inspection go?
The most recent inspection on record closed on 18 September 2025 as NAI (No Action Indicated: nothing objectionable was found). 6 inspections are on file.
Where does Delmar Chemicals manufacture?
1 registered site is on record, in Canada (Canada). Every site is listed on this page with the register it came from.
What does Delmar Chemicals make?
15 molecules are on record against Delmar Chemicals, including Apixaban, Eslicarbazepine Acetate, Esmolol and Fluorescein. Each links through to that molecule's full manufacturer list.
Which regulators recognise Delmar Chemicals'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

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was NAI, on 18 September 2025.

Comparable suppliers

MSN Laboratories shares 5 molecules Apitoria Pharma shares 4 molecules Hetero shares 4 molecules Dr Reddy's Laboratories shares 4 molecules Cipla shares 3 molecules

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