Suppliers / Topchem Pharmaceuticals

Topchem Pharmaceuticals

Ireland 30 employees Updated 9 July 2026

Topchem Pharmaceuticals is an API manufacturer based in Ireland. It holds 4 active US drug master files across a filed portfolio of 4 molecules. Its most recent recorded inspection, by US FDA, closed on 2 September 2022 as VAI.

4
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
0
filings across 0 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

  • 2 September 2022 VAI US FDA
  • 19 February 2016 VAI US FDA
  • 23 May 2013 NAI US FDA
  • 20 August 2009 VAI US FDA

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

Registered plants

Site FDA FEI
Ireland, Ireland 3006810418

What they file, and where

Molecule Regulators Docs
Bretylium SFDA (Saudi Arabia), US FDA 2
Etacrynic Acid US FDA 1
Malathion US FDA 1
Tolcapone US FDA 1

Questions about Topchem Pharmaceuticals

Does Topchem Pharmaceuticals hold a US DMF or a CEP?
Topchem Pharmaceuticals holds 4 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 Topchem Pharmaceuticals FDA-registered?
One site operated by Topchem Pharmaceuticals 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 Topchem Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 2 September 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Topchem Pharmaceuticals manufacture?
1 registered site is on record, in Ireland (Ireland). Every site is listed on this page with the register it came from.
What does Topchem Pharmaceuticals make?
4 molecules are on record against Topchem Pharmaceuticals, including Bretylium, Etacrynic Acid, Malathion and Tolcapone. Each links through to that molecule's full manufacturer list.

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 2 September 2022.

Comparable suppliers

Mallinckrodt also in Ireland Astellas Ireland also in Ireland Clarochem Ireland also in Ireland Mylan Dublin also in Ireland Sigma-Aldrich Ireland also in Ireland

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