Suppliers / Hovione Farmaciência

Hovione Farmaciência

Portugal Updated 9 July 2026

Hovione Farmaciência is an API and finished-dose manufacturer based in Portugal. It holds 26 active US drug master files and 9 valid CEPs across a filed portfolio of 8 molecules. Its filings concentrate with MINSA (CR) and INVIMA (CO). Its GMP standing is certified by EMA and INFARMED (PT).

26
active US DMFs
9
valid CEPs
6
registered plants
8
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Loures, Portugal Not on file
Lumiar, Portugal Not on file
Lisboa, Portugal Not on file
LOURES, Portugal Not on file
Lisboa, Portugal Not on file
Loures, Portugal Not on file

What they file, and where

Molecule Regulators Docs
Fluticasone Propionate EDQM, SFDA (Saudi Arabia), US FDA 9
Minocycline EDQM, US FDA 6
Mometasone Furoate EDQM, US FDA 6
Betamethasone US FDA 4
Doxycycline US FDA 4
Salmeterol EDQM, US FDA 4
Halobetasol Propionate US FDA 2
Fluticasone Furoate EDQM 1

Also appears on these molecule pages

Beclomethasone contract manufacturing Betamethasone contract manufacturing Doxycycline contract manufacturing Fluticasone API Glycopyrronium contract manufacturing Halobetasol contract manufacturing Hydrocortisone contract manufacturing Indacaterol contract manufacturing Ivermectin contract manufacturing Minocycline contract manufacturing Mometasone contract manufacturing Roxithromycin contract manufacturing
Show 5 more molecule pages
Salmeterol contract manufacturing Semaglutide finished dose Tiotropium contract manufacturing Umeclidinium contract manufacturing Vilanterol contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 5 None
INVIMA (CO) 3 None
EMA None 5
INFARMED (PT) None 4

Questions about Hovione Farmaciência

Does Hovione Farmaciência hold a US DMF or a CEP?
Hovione Farmaciência holds 26 active US drug master files and 9 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.
Where does Hovione Farmaciência manufacture?
6 registered sites are on record, in Portugal (Loures, Lumiar and Lisboa among others). Every site is listed on this page with the register it came from.
What does Hovione Farmaciência make?
8 molecules are on record against Hovione Farmaciência, including Fluticasone Propionate, Minocycline, Mometasone Furoate and Betamethasone. Each links through to that molecule's full manufacturer list.
Which regulators recognise Hovione Farmaciência's GMP?
Current GMP certificates are on record from EMA and INFARMED (PT). 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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Sources on this page

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