Suppliers / Polfa Tarchomin

Polfa Tarchomin

Poland Updated 9 July 2026

Polfa Tarchomin is an API and finished-dose manufacturer based in Poland. It holds one active US drug master file. Its filings concentrate with RCETH (BY), RAMA (GE) and DAV (Vietnam). Its GMP standing is certified by EAEU_EEC.

1
active US DMFs
0
valid CEPs
0
registered plants
42
filings across 5 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
0 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

What they file, and where

Molecule Regulators Docs
Erythromycin US FDA 1

Also appears on these molecule pages

Chlordiazepoxide finished dose Erythromycin API Oxazepam finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
RCETH (BY) 21 None
RAMA (GE) 10 None
DAV (Vietnam) 5 None
DMP (NO) 3 None
UZPHARM (UZ) 3 None
EAEU_EEC None 2

Questions about Polfa Tarchomin

Does Polfa Tarchomin hold a US DMF or a CEP?
Polfa Tarchomin holds 1 active US drug master file. 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.
What does Polfa Tarchomin make?
1 molecule is on record against Polfa Tarchomin, including Erythromycin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Polfa Tarchomin's GMP?
Current GMP certificates are on record from EEC (Eurasian Economic Union). 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