Suppliers / Pharmaceutical Works Polpharma

Pharmaceutical Works Polpharma

Poland 2 duplicate records merged Updated 9 July 2026

Pharmaceutical Works Polpharma is an API and finished-dose manufacturer based in Poland. It appears in 222 regulatory filings across 10 regulators, without an active US DMF or CEP on file. Its filings concentrate with RCETH (BY), DAV (Vietnam) and UZPHARM (UZ). Its GMP standing is certified by EAEU_EEC and UZPHARM (UZ).

0
active US DMFs
0
valid CEPs
3
registered plants
222
filings across 10 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.

Registered plants

Site FDA FEI
Starogard Gdanski, United Arab Emirates Not on file
Starogard Gdanski, United Arab Emirates Not on file
Нова-Демба, Belarus Not on file

What they file, and where

Molecule Regulators Docs
Apixaban SFDA (Saudi Arabia) 2
Baclofen SFDA (Saudi Arabia) 2
Zoledronic Acid SFDA (Saudi Arabia) 2
Aripiprazole SFDA (Saudi Arabia) 1
Cyclobenzaprine SFDA (Saudi Arabia) 1
Dapagliflozin Propanediol SFDA (Saudi Arabia) 1
Linagliptin SFDA (Saudi Arabia) 1
Sildenafil SFDA (Saudi Arabia) 1
Sitagliptin SFDA (Saudi Arabia) 1
Sodium Alendronate SFDA (Saudi Arabia) 1
Show all 13 molecules on file
Tadalafil SFDA (Saudi Arabia) 1
Ticagrelor SFDA (Saudi Arabia) 1
Vardenafil SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Avibactam finished dose Baclofen API Ciclopirox Olamine finished dose Cyclobenzaprine API Dapagliflozin Propanediol API Eplerenone finished dose Indapamide finished dose Pentoxifylline finished dose Pyrantel finished dose Sildenafil API Sodium Alendronate API Vardenafil API
Show 8 more molecule pages
Xylometazoline finished dose Zoledronic Acid API Sitagliptin API Tadalafil API Linagliptin API Ticagrelor API Apixaban API Aripiprazole API

Filings and GMP by regulator

Regulator Filings GMP certificates
RCETH (BY) 74 None
DAV (Vietnam) 62 None
UZPHARM (UZ) 36 2
MPA (SE) 16 None
RAMA (GE) 9 None
MINSA (CR) 8 None
EAEU_EEC None 3

Questions about Pharmaceutical Works Polpharma

Does Pharmaceutical Works Polpharma hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Pharmaceutical Works Polpharma. It does have 222 filings with 10 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Pharmaceutical Works Polpharma manufacture?
3 registered sites are on record, in United Arab Emirates and Belarus (Starogard Gdanski and Нова-демба among others). Every site is listed on this page with the register it came from.
What does Pharmaceutical Works Polpharma make?
13 molecules are on record against Pharmaceutical Works Polpharma, including Apixaban, Baclofen, Zoledronic Acid and Aripiprazole. Each links through to that molecule's full manufacturer list.
Which regulators recognise Pharmaceutical Works Polpharma's GMP?
Current GMP certificates are on record from EEC (Eurasian Economic Union) and UZPHARM (UZ). 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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Comparable suppliers

Dr Reddy's Laboratories shares 4 molecules Zaklady Farmaceutyczne Polpharma shares 4 molecules Hetero shares 3 molecules Macleods Pharmaceuticals shares 3 molecules Apitoria Pharma shares 2 molecules

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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