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

Bupivacaine finished dose Fondaparinux API Ropivacaine finished dose

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 We do not publish the identity of any buyer.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.

Questions about Aspen Notre Dame De Bondeville

Does Aspen Notre Dame De Bondeville hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Aspen Notre Dame De Bondeville. It does have 33 filings with 7 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Aspen Notre Dame De Bondeville FDA-registered?
One site operated by Aspen Notre Dame De Bondeville 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 Aspen Notre Dame De Bondeville's last inspection go?
The most recent inspection on record closed on 7 November 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 7 inspections are on file.
Where does Aspen Notre Dame De Bondeville manufacture?
4 registered sites are on record, in United Arab Emirates and France (Notre-dame De Bondeville, Notre Dame DE Bondeville and Notre-dame-de-bondeville among others). Every site is listed on this page with the register it came from.
What does Aspen Notre Dame De Bondeville make?
1 molecule is on record against Aspen Notre Dame De Bondeville, including Fondaparinux. Each links through to that molecule's full manufacturer list.
Which regulators recognise Aspen Notre Dame De Bondeville's GMP?
Current GMP certificates are on record from ANSM (FR), ANVISA (Brazil), EMA and US FDA. 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 7 November 2025.

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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
Company filings
Revenue as reported