Suppliers / Pierre Fabre Médicament;

Pierre Fabre Médicament;

France 2 duplicate records merged Updated 9 July 2026

Pierre Fabre Médicament; is an API and finished-dose manufacturer based in France. It holds 4 active US drug master files and 4 valid CEPs across a filed portfolio of 6 molecules. Its filings concentrate with EMA, ANSM (FR) and INFARMED (PT). Its GMP standing is certified by ANSM (FR), HSA (SG) and INFARMED (PT), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 8 July 2022 as VAI.

4
active US DMFs
4
valid CEPs
12
registered plants 1 with an FDA FEI number
852
filings across 28 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 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

  • 8 July 2022 VAI US FDA
  • 13 July 2018 VAI US FDA
  • 15 April 2016 VAI US FDA
  • 14 March 2013 NAI US FDA

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

Registered plants

Site FDA FEI
GAILLAC, France Not on file
Gaillac, France Not on file
Ussel, France Not on file
France, France 3002807889
Gien, France Not on file
Cuautitlán, Mexico Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Ossein Hydroxyapatite Compound EDQM 2
Vinorelbine EDQM, US FDA 2
Levomilnacipran US FDA 1
Milnacipran US FDA 1
Mucoproteose EDQM 1
Vinflunine US FDA 1

Also appears on these molecule pages

Arginine finished dose Benzoyl Peroxide finished dose Bicalutamide finished dose Busulfan finished dose Caffeine finished dose Calci finished dose Carbocisteine finished dose Chlorhexidine finished dose Ciclopirox finished dose Ciclopirox Olamine finished dose Clobetasol finished dose Codeine finished dose
Show 35 more molecule pages
Desogestrel finished dose Dextromethorphan finished dose Domperidone finished dose Erythromycin finished dose Ethinylestradiol finished dose Etoposide finished dose Ferrous finished dose Fluorouracil finished dose Glucosamine finished dose Hesperidin finished dose Isotretinoin finished dose Ivermectin finished dose Leucine finished dose Levomenthol finished dose Levomilnacipran API Lysine finished dose Methionine finished dose Milnacipran API Minoxidil finished dose Nicotine finished dose Phenylalanine finished dose Piroxicam finished dose Prilocaine finished dose Propranolol finished dose Salicylic Acid finished dose Spiramycin finished dose Tacrolimus finished dose Terbinafine finished dose Tetracaine finished dose Theophylline finished dose Tretinoin finished dose Triamcinolone finished dose Valine finished dose Vibegron finished dose Vinorelbine API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 159 2
ANSM (FR) 126 19
INFARMED (PT) 123 2
EDA (EG) 88 None
AIFA (IT) 59 None
FAMHP (BE) 43 None
HSA (SG) None 2

Questions about Pierre Fabre Médicament;

Does Pierre Fabre Médicament; hold a US DMF or a CEP?
Pierre Fabre Médicament; holds 4 active US drug master files and 4 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 Pierre Fabre Médicament; FDA-registered?
One site operated by Pierre Fabre Médicament; 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 Pierre Fabre Médicament;'s last inspection go?
The most recent inspection on record closed on 8 July 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Pierre Fabre Médicament; manufacture?
12 registered sites are on record, in France, Mexico and Portugal (Gaillac, Gaillac and Ussel among others). Every site is listed on this page with the register it came from.
What does Pierre Fabre Médicament; make?
6 molecules are on record against Pierre Fabre Médicament;, including Ossein Hydroxyapatite Compound, Vinorelbine, Levomilnacipran and Milnacipran. Each links through to that molecule's full manufacturer list.
Which regulators recognise Pierre Fabre Médicament;'s GMP?
Current GMP certificates are on record from ANSM (FR), HSA (SG), INFARMED (PT) and EMA. 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 8 July 2022.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates