Suppliers / Roquette Frères

Roquette Frères

France 2 duplicate records merged Updated 9 July 2026

Roquette Frères is an API manufacturer based in France. It holds 4 active US drug master files and 7 valid CEPs across a filed portfolio of 9 molecules. Its GMP standing is certified by ANSM (FR) and MFDS (Korea). Its most recent recorded inspection, by US FDA, closed on 4 December 2020 as VAI.

4
active US DMFs
7
valid CEPs
2
registered plants 1 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 4 December 2020 VAI US FDA
  • 10 November 2017 VAI US FDA
  • 10 February 2017 VAI US FDA
  • 29 May 2015 VAI US FDA
  • 23 October 2012 NAI US FDA

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

Registered plants

Site FDA FEI
Lestrem, France Not on file
France, France 1000114558

What they file, and where

Molecule Regulators Docs
Dextrose SFDA (Saudi Arabia), US FDA 4
Mannitol EDQM, US FDA 3
Sorbitol EDQM, US FDA 3
2-Hydroxylpropyl-Beta-Cyclodextrin US FDA 1
Betadex EDQM 1
Glucose Monohydrate EDQM 1
Hydroxypropylbetadex EDQM 1
Lidocaine SFDA (Saudi Arabia) 1
Sodium Bicarbonate SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Lidocaine API

Filings and GMP by regulator

Regulator Filings GMP certificates
EEC_EAEU 1 None
ANSM (FR) None 26
MFDS (Korea) None 2

Questions about Roquette Frères

Does Roquette Frères hold a US DMF or a CEP?
Roquette Frères holds 4 active US drug master files and 7 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 Roquette Frères FDA-registered?
One site operated by Roquette Frères 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 Roquette Frères's last inspection go?
The most recent inspection on record closed on 4 December 2020 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Roquette Frères manufacture?
2 registered sites are on record, in France (Lestrem and France). Every site is listed on this page with the register it came from.
What does Roquette Frères make?
9 molecules are on record against Roquette Frères, including Dextrose, Mannitol, Sorbitol and 2-Hydroxylpropyl-Beta-Cyclodextrin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Roquette Frères's GMP?
Current GMP certificates are on record from ANSM (FR) and MFDS (Korea). 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. Roquette Frères 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 4 December 2020.

Comparable suppliers

Moehs shares 1 molecule Harman Finochem shares 1 molecule Swati Spentose shares 1 molecule Viwit Pharmaceutical shares 1 molecule W. R. Grace & Co.-Conn shares 1 molecule

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