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 1 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
1 of 1 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
Cedex, United Arab Emirates Not on file
Le Trait, United Arab Emirates Not on file
Maison Alfort 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

Chlorpromazine API Clopidogrel API Ezetimibe finished dose Furosemide finished dose Glibenclamide finished dose Glimepiride finished dose Irbesartan API Isoniazid finished dose Metoclopramide finished dose Nebivolol finished dose Olmesartan Medoxomil finished dose Pyrazinamide finished dose
Show 6 more molecule pages
Ramipril finished dose Rifampicin finished dose Sucralfate finished dose Valproic Acid API Vigabatrin finished dose Zolpidem 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.

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Open risk flags

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

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