Suppliers / Pharmathen

Pharmathen

Greece Updated 9 July 2026

Pharmathen is an API and finished-dose manufacturer based in Greece. It holds 5 active US drug master files across a filed portfolio of 5 molecules. Its filings concentrate with EMA, AIFA (IT) and INFARMED (PT). Its GMP standing is certified by MFDS (Korea), EMA and NCELS (KZ).

5
active US DMFs
0
valid CEPs
3
registered plants
567
filings across 18 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
Sapes, United Arab Emirates Not on file
Pallini, United Arab Emirates Not on file
Pallini, Greece Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 162 1
AIFA (IT) 132 None
INFARMED (PT) 57 None
AEMPS (ES) 53 None
FAMHP (BE) 49 None
MPA (SE) 43 None
MFDS (Korea) None 2
NCELS (KZ) None 1

Questions about Pharmathen

Does Pharmathen hold a US DMF or a CEP?
Pharmathen holds 5 active US drug master files. 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 Pharmathen manufacture?
3 registered sites are on record, in United Arab Emirates and Greece (Sapes and Pallini among others). Every site is listed on this page with the register it came from.
What does Pharmathen make?
5 molecules are on record against Pharmathen, including Aprepitant, Brinzolamide, Paliperidone and Valganciclovir. Each links through to that molecule's full manufacturer list.
Which regulators recognise Pharmathen's GMP?
Current GMP certificates are on record from MFDS (Korea), EMA and NCELS (KZ). 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