Suppliers / Sophartex

Sophartex

France Updated 9 July 2026

Sophartex is a finished-dose manufacturer based in France. It appears in 66 regulatory filings across 10 regulators, without an active US DMF or CEP on file. Its filings concentrate with FDA (GH), DIGEMAPS (DO) and ARCSA (EC). Its GMP standing is certified by ANSM (FR), ANVISA (Brazil) and NAFDAC (NG), among 4 authorities.

0
active US DMFs
0
valid CEPs
3
registered plants
66
filings across 10 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Vernouillet, United Arab Emirates Not on file
Vernouillet, United Arab Emirates Not on file
VERNOUILLET, France Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
FDA (GH) 41 None
DIGEMAPS (DO) 6 None
ARCSA (EC) 3 None
NAFDAC (NG) 3 1
NPRA (MY) 3 None
EDE (AE) 3 None
ANSM (FR) None 5
ANVISA (Brazil) None 1
EMA None 1

Scale

Year Revenue Exports Destinations
2023 $47.4M Not reported Not reported

Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.

Questions about Sophartex

Does Sophartex hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Sophartex. It does have 66 filings with 10 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Sophartex manufacture?
3 registered sites are on record, in United Arab Emirates and France (Vernouillet and Vernouillet among others). Every site is listed on this page with the register it came from.
Which regulators recognise Sophartex's GMP?
Current GMP certificates are on record from ANSM (FR), ANVISA (Brazil), NAFDAC (NG) 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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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates
Company filings
Revenue as reported