Suppliers / Omya International

Omya International

Switzerland 2 duplicate records merged Updated 9 July 2026

Omya International is an API manufacturer based in Switzerland. It holds one active US drug master file and one valid CEP across a filed portfolio of 2 molecules. Its GMP standing is certified by ANSM (FR). Its most recent recorded inspection, by US FDA, closed on 27 May 2022 as VAI.

1
active US DMFs
1
valid CEPs
4
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
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 27 May 2022 VAI US FDA
  • 25 July 2016 VAI US FDA
  • 20 August 2012 NAI US FDA
  • 9 September 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
ORGON, France Not on file
Omey, France Not on file
Orgon, France Not on file
Superior, United States 3003624292

What they file, and where

Molecule Regulators Docs
Calcium US FDA 1
Calcium Carbonate EDQM 1

Also appears on these molecule pages

Calcium Carbonate API

Filings and GMP by regulator

Regulator Filings GMP certificates
EEC_EAEU 1 None
ANSM (FR) None 18

Questions about Omya International

Does Omya International hold a US DMF or a CEP?
Omya International holds 1 active US drug master file and 1 valid CEP. 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 Omya International FDA-registered?
One site operated by Omya International 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 Omya International's last inspection go?
The most recent inspection on record closed on 27 May 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Omya International manufacture?
4 registered sites are on record, in France and United States (Orgon, Omey and Orgon among others). Every site is listed on this page with the register it came from.
What does Omya International make?
2 molecules are on record against Omya International, including Calcium and Calcium Carbonate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Omya International's GMP?
Current GMP certificates are on record from ANSM (FR). 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 27 May 2022.

Comparable suppliers

Emnar Pharma shares 1 molecule J.M. Huber Micropowders shares 1 molecule Mochen Pharmaceutical (Hubei) shares 1 molecule Mineraria Sacilese shares 1 molecule Scora shares 1 molecule

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