Suppliers / Elementis Pharma

Elementis Pharma

Germany Updated 9 July 2026

Elementis Pharma is a contract manufacturer based in Germany. Its GMP standing is certified by ZLG (DE) and EMA. Its most recent recorded inspection, by US FDA, closed on 6 February 2020 as VAI.

0
active US DMFs
0
valid CEPs
3
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
2 of 2 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

  • 6 February 2020 VAI US FDA
  • 26 January 2016 VAI US FDA

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

Registered plants

Site FDA FEI
Ludwigshafen Am Rhein, Germany Not on file
Rhineland-Palatinate, Germany Not on file
Germany, Germany 3002807069

Filings and GMP by regulator

Regulator Filings GMP certificates
ZLG (DE) None 6
EMA None 2

Questions about Elementis Pharma

Is Elementis Pharma FDA-registered?
One site operated by Elementis Pharma 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 Elementis Pharma's last inspection go?
The most recent inspection on record closed on 6 February 2020 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Elementis Pharma manufacture?
3 registered sites are on record, in Germany (Ludwigshafen Am Rhein, Rhineland-palatinate and Germany). Every site is listed on this page with the register it came from.
Which regulators recognise Elementis Pharma's GMP?
Current GMP certificates are on record from ZLG (DE) and EMA. 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 6 February 2020.

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