Suppliers / Pierre Fabre Médicament;

Pierre Fabre Médicament;

Portugal 2 duplicate records merged Updated 9 July 2026

Pierre Fabre Médicament; is a finished-dose manufacturer based in Portugal. 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
France, France 3002807889
Ussel, France Not on file
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

Benzoyl Peroxide finished dose Bicalutamide finished dose Caffeine finished dose Carbocisteine finished dose Ciclopirox finished dose Clobetasol finished dose Codeine finished dose Desogestrel finished dose Dextromethorphan finished dose Domperidone finished dose Doxycycline finished dose Erythromycin finished dose
Show 16 more molecule pages
Ethinylestradiol finished dose Heparin finished dose Isotretinoin finished dose Ivermectin finished dose Lactulose finished dose Levonorgestrel finished dose Lysine finished dose Minoxidil finished dose Nicotine finished dose Piroxicam finished dose Propranolol finished dose Salicylic Acid finished dose Tacrolimus finished dose Terbinafine finished dose Tretinoin finished dose Triamcinolone finished dose

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

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Open risk flags

  • The most recent inspection outcome was VAI, on 8 July 2022.

Sources on this page

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