Suppliers / Clarochem Ireland

Clarochem Ireland

Ireland 2 duplicate records merged Updated 9 July 2026

Clarochem Ireland is an API manufacturer based in Ireland. It holds 2 valid CEPs across a filed portfolio of 2 molecules.

0
active US DMFs
2
valid CEPs
1
registered plants
2
filings across 1 regulators

Registered plants

Site FDA FEI
Dublin 15, Ireland Not on file

What they file, and where

Molecule Regulators Docs
Levodropropizine EDQM, SFDA (Saudi Arabia) 2
Fosfomycin EDQM 1

Also appears on these molecule pages

Fosfomycin API Levodropropizine API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 2 None

Questions about Clarochem Ireland

Does Clarochem Ireland hold a US DMF or a CEP?
Clarochem Ireland holds 2 valid CEPs. 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.
Where does Clarochem Ireland manufacture?
1 registered site is on record, in Ireland (Dublin 15). Every site is listed on this page with the register it came from.
What does Clarochem Ireland make?
2 molecules are on record against Clarochem Ireland, including Levodropropizine and Fosfomycin. Each links through to that molecule's full manufacturer list.
Where does Clarochem Ireland file?
Filings are on record with MINSA (CR), 2 in total.

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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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability