Ecolab

United States Updated 9 July 2026

Ecolab is a finished-dose manufacturer based in United States. It appears in 271 regulatory filings across 11 regulators, without an active US DMF or CEP on file. Its filings concentrate with EEC_EAEU, Health Canada and EMA. Its GMP standing is certified by ZLG (DE), EMA and ISP (CL). Its most recent recorded inspection, by US FDA, closed on 9 November 2018 as VAI.

active US DMFs

valid CEPs

registered plants 4 with an FDA FEI number

271

filings across 11 regulators

These figures were checked against the regulators' own files on 25 July 2026

Plants

4 of 4 confirmed

Inspections

6 of 6 confirmed

EU GMP

1 of 1 confirmed

Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

9 November 2018 VAI US FDA
22 March 2017 NAI US FDA
24 June 2016 VAI US FDA
1 April 2013 NAI US FDA
9 September 2010 NAI US FDA
18 December 2008 NAI US FDA

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

Registered plants

Site	FDA FEI
Leeds, United Arab Emirates	Not on file
Monheim Am Rhein, Germany	Not on file
North Rhine-Westphalia, Germany	Not on file
CALLAO, Peru	Not on file
MONTERNÉS DEL VALLÉS, Portugal	Not on file
Eagan, United States	1000139948

3 further sites are on record.

Filings and GMP by regulator

Regulator	Filings	GMP certificates
EEC_EAEU	157	None
Health Canada	79	None
EMA	8	1
URPL (PL)	6	None
ISP (CL)	6	1
EDE (AE)	6	None
ZLG (DE)	None	4

Questions about Ecolab

Does Ecolab hold a US DMF or a CEP?

No active US drug master file or valid CEP is on record for Ecolab. It does have 271 filings with 11 regulators, so it is registered, just not with the two strong registers buyers usually screen on.

Is Ecolab FDA-registered?

4 sites operated by Ecolab carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.

How did Ecolab's last inspection go?

The most recent inspection on record closed on 9 November 2018 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.

Where does Ecolab manufacture?

9 registered sites are on record, in United Arab Emirates, Germany, Peru and Portugal (Leeds, Monheim Am Rhein and North Rhine-westphalia among others). Every site is listed on this page with the register it came from.

Which regulators recognise Ecolab's GMP?

Current GMP certificates are on record from ZLG (DE), EMA and ISP (CL). 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 9 November 2018.

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