Suppliers / Steriscience

Steriscience

Poland Updated 9 July 2026

Steriscience is a finished-dose manufacturer based in Poland. It appears in 72 regulatory filings across 8 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, US FDA and AIFA (IT). Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 28 April 2023 as VAI.

0
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
72
filings across 8 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 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

  • 28 April 2023 VAI US FDA
  • 14 February 2014 OAI US FDA
  • 13 September 2012 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Poland, Poland 3009685660
Warsaw, Poland Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 44 1
US FDA 11 None
AIFA (IT) 5 None
AEMPS (ES) 4 None
INFARMED (PT) 3 None
MPA (SE) 2 None

Questions about Steriscience

Does Steriscience hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Steriscience. It does have 72 filings with 8 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Steriscience FDA-registered?
One site operated by Steriscience carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Steriscience's last inspection go?
The most recent inspection on record closed on 28 April 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file, of which 1 closed as OAI.
Where does Steriscience manufacture?
2 registered sites are on record, in Poland (Poland and Warsaw). Every site is listed on this page with the register it came from.
Which regulators recognise Steriscience's GMP?
Current GMP certificates are on record from EMA. 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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Open risk flags

  • The most recent inspection outcome was VAI, on 28 April 2023.

Comparable suppliers

Delpharm Poznan also in Poland Pharmaceutical Works Polpharma also in Poland Ifotam also in Poland Polfa Tarchomin also in Poland Sieć Badawcza Łukasiewicz – Instytut Farmaceutyczny also in Poland

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