Suppliers / Aspen Notre Dame De Bondeville

Aspen Notre Dame De Bondeville

France Updated 9 July 2026

Aspen Notre Dame De Bondeville is an API and finished-dose manufacturer based in France. It appears in 33 regulatory filings across 7 regulators, without an active US DMF or CEP on file. Its filings concentrate with NPRA (MY), ARCSA (EC) and EDE (AE). Its GMP standing is certified by ANSM (FR), ANVISA (Brazil) and EMA, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 7 November 2025 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
33
filings across 7 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
7 of 7 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

  • 7 November 2025 VAI US FDA
  • 16 April 2021 VAI US FDA
  • 31 May 2018 NAI US FDA
  • 30 August 2016 NAI US FDA
  • 17 September 2013 NAI US FDA
  • 2 September 2011 VAI US FDA
  • 17 March 2009 VAI US FDA

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

Registered plants

Site FDA FEI
Notre-Dame de Bondeville, United Arab Emirates Not on file
NOTRE DAME DE BONDEVILLE, France Not on file
NOTRE-DAME-DE-BONDEVILLE, France Not on file
France, France 3002808079

What they file, and where

Molecule Regulators Docs
Fondaparinux SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
NPRA (MY) 14 None
ARCSA (EC) 5 None
EDE (AE) 5 None
UZPHARM (UZ) 4 None
MINSA (CR) 2 None
DIGEMAPS (DO) 2 None
ANSM (FR) None 13
ANVISA (Brazil) None 3
EMA None 1
US FDA None 1

Scale

Year Revenue Exports Destinations
2023 $389.0M 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 We do not publish the identity of any buyer.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.

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Open risk flags

  • The most recent inspection outcome was VAI, on 7 November 2025.

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