Suppliers / Glaxo Wellcome Production

Glaxo Wellcome Production

France Updated 9 July 2026

Glaxo Wellcome Production is an API and finished-dose manufacturer based in France. It appears in 46 regulatory filings across 7 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), NAFDAC (NG) and INVIMA (CO). Its GMP standing is certified by ANSM (FR), ANVISA (Brazil) and MFDS (Korea), among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 8 April 2022 as VAI.

0
active US DMFs
0
valid CEPs
7
registered plants 1 with an FDA FEI number
46
filings across 7 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 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

  • 8 April 2022 VAI US FDA
  • 3 March 2017 VAI US FDA
  • 11 April 2014 NAI US FDA
  • 27 February 2012 NAI US FDA
  • 19 March 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
Evreux, United Arab Emirates Not on file
MAYENNE, United Arab Emirates Not on file
MAYENNE, France Not on file
NOTRE DAME DE BONDEVILLE, France Not on file
France, France 3002807436
Evreux, France Not on file

1 further sites are on record.

What they file, and where

Molecule Regulators Docs
Fluticasone Propionate SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Flumazenil finished dose Fluticasone API Salmeterol finished dose Sulbactam finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 18 None
NAFDAC (NG) 7 2
INVIMA (CO) 6 None
DIGEMAPS (DO) 5 None
UZPHARM (UZ) 5 None
MINSA (CR) 4 None
ANSM (FR) None 12
ANVISA (Brazil) None 3
MFDS (Korea) None 2
EMA None 2
FDA (GH) None 1

Scale

Year Revenue Exports Destinations
2024 $234.1M 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 We do not publish the identity of any buyer.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 Glaxo Wellcome Production

Does Glaxo Wellcome Production hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Glaxo Wellcome Production. It does have 46 filings with 7 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Glaxo Wellcome Production FDA-registered?
One site operated by Glaxo Wellcome Production 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 Glaxo Wellcome Production's last inspection go?
The most recent inspection on record closed on 8 April 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Glaxo Wellcome Production manufacture?
7 registered sites are on record, in United Arab Emirates, France and Nigeria (Evreux, Mayenne and Notre Dame DE Bondeville among others). Every site is listed on this page with the register it came from.
What does Glaxo Wellcome Production make?
1 molecule is on record against Glaxo Wellcome Production, including Fluticasone Propionate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Glaxo Wellcome Production's GMP?
Current GMP certificates are on record from ANSM (FR), ANVISA (Brazil), MFDS (Korea), NAFDAC (NG), EMA and 1 more. 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 8 April 2022.

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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