Suppliers / Sanofi Winthrop Industrie

Sanofi Winthrop Industrie

France Updated 9 July 2026

Sanofi Winthrop Industrie is an API and finished-dose manufacturer based in France. It holds 17 valid CEPs across a filed portfolio of 16 molecules. Its filings concentrate with AIFA (IT), EMA and ANSM (FR). Its GMP standing is certified by ANSM (FR), ANVISA (Brazil) and EMA, among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 26 January 2024 as VAI. Customs aggregates show $1.1M of exports covering 83 molecules to 6 destinations in 2022.

0
active US DMFs
17
valid CEPs
12
registered plants 2 with an FDA FEI number
1,357
filings across 17 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
6 of 8 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

  • 26 January 2024 VAI US FDA
  • 12 January 2024 NAI US FDA
  • 22 November 2023 VAI US FDA
  • 17 November 2023 VAI US FDA
  • 29 September 2023 VAI US FDA
  • 12 May 2023 VAI US FDA
  • 25 April 2023 VAI US FDA
  • 10 March 2023 VAI US FDA

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

Registered plants

Site FDA FEI
Maison Alfort Cedex, United Arab Emirates Not on file
Le Trait, United Arab Emirates Not on file
Cedex, United Arab Emirates Not on file
Tours, United Arab Emirates Not on file
Marcy L' Etoile, United Arab Emirates Not on file
Val De Reuil, United Arab Emirates Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Irbesartan EDQM, SFDA (Saudi Arabia) 3
Amiodarone EDQM 1
Amisulpride EDQM 1
Carbaspirin Calcium EDQM 1
Chlorpromazine EDQM 1
Ciprofibrate EDQM 1
Clopidogrel EDQM 1
Dipotassium Clorazepate EDQM 1
Docetaxel EDQM 1
Promethazine EDQM 1
Show all 16 molecules on file
Sodium Valproate EDQM 1
Ticlopidine EDQM 1
Trimipramine EDQM 1
Valproic Acid EDQM 1
Zolpidem EDQM 1
Zopiclone EDQM 1

Also appears on these molecule pages

Adenosine finished dose Alfuzosin finished dose Amiodarone API Amisulpride API Avanafil finished dose Cabazitaxel finished dose Candesartan Cilexetil finished dose Cefotaxime finished dose Cefpodoxime finished dose Chlorpromazine API Ciprofibrate API Clopidogrel API
Show 36 more molecule pages
Dacarbazine finished dose Dapsone finished dose Daunorubicin finished dose Docetaxel API Dronedarone finished dose Enoxaparin finished dose Ezetimibe finished dose Ferrous finished dose Glibenclamide finished dose Glimepiride finished dose Glyburide finished dose Hydroxychloroquine finished dose Irbesartan API Isoniazid finished dose Ketoprofen finished dose Levothyroxine finished dose Metoclopramide finished dose Milrinone finished dose Nebivolol finished dose Olmesartan Medoxomil finished dose Promethazine API Pyrazinamide finished dose Quinapril finished dose Ramipril finished dose Rifampicin finished dose Rifampin finished dose Riluzole finished dose Sevelamer finished dose Sodium Valproate API Sucralfate finished dose Teicoplanin finished dose Teriflunomide finished dose Valproic Acid API Vigabatrin finished dose Zolpidem API Zopiclone API

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 492 None
EMA 323 9
ANSM (FR) 194 85
INFARMED (PT) 107 None
MPA (SE) 94 None
DMP (NO) 36 None
ANVISA (Brazil) None 13
US FDA None 6
MFDS (Korea) None 6
EAEU_EEC None 4
NAFDAC (NG) None 2

Scale

Year Revenue Exports Destinations
2024 $26.1B Not reported Not reported
2022 Not reported $1.1M 6

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 Sanofi Winthrop Industrie

Does Sanofi Winthrop Industrie hold a US DMF or a CEP?
Sanofi Winthrop Industrie holds 17 valid CEPs. 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 Sanofi Winthrop Industrie FDA-registered?
2 sites operated by Sanofi Winthrop Industrie 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 Sanofi Winthrop Industrie's last inspection go?
The most recent inspection on record closed on 26 January 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Sanofi Winthrop Industrie manufacture?
12 registered sites are on record, in United Arab Emirates and France (Maison Alfort Cedex, Le Trait and Cedex among others). Every site is listed on this page with the register it came from.
What does Sanofi Winthrop Industrie make?
16 molecules are on record against Sanofi Winthrop Industrie, including Irbesartan, Amiodarone, Amisulpride and Carbaspirin Calcium. Each links through to that molecule's full manufacturer list.
Which regulators recognise Sanofi Winthrop Industrie's GMP?
Current GMP certificates are on record from ANSM (FR), ANVISA (Brazil), EMA, US FDA, MFDS (Korea) and 2 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.

Comparing suppliers?

Choose your molecules and target markets. Sanofi Winthrop Industrie comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was VAI, on 26 January 2024.

Comparable suppliers

Sanofi shares 5 molecules Apitoria Pharma shares 4 molecules Dr Reddy's Laboratories shares 4 molecules Hetero shares 3 molecules Zydus Lifesciences shares 3 molecules

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
Customs aggregates
Export values, molecule and destination counts
Company filings
Revenue as reported