Suppliers / Biologici Italia Laboratories

Biologici Italia Laboratories

Italy 61 employees Updated 9 July 2026

Biologici Italia Laboratories is a finished-dose manufacturer based in Italy. It appears in 6 regulatory filings across 4 regulators, without an active US DMF or CEP on file. Its filings concentrate with UZPHARM (UZ), INVIMA (CO) and NCELS (KZ). Its GMP standing is certified by EMA and EAEU_EEC.

0
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
6
filings across 4 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Masate, Italy Not on file
Italy, Italy 3014851769

Filings and GMP by regulator

Regulator Filings GMP certificates
UZPHARM (UZ) 3 None
INVIMA (CO) 1 None
NCELS (KZ) 1 None
ANPP (DZ) 1 None
EMA None 2
EAEU_EEC None 1

Questions about Biologici Italia Laboratories

Does Biologici Italia Laboratories hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Biologici Italia Laboratories. It does have 6 filings with 4 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Biologici Italia Laboratories FDA-registered?
One site operated by Biologici Italia Laboratories 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.
Where does Biologici Italia Laboratories manufacture?
2 registered sites are on record, in Italy (Masate and Italy). Every site is listed on this page with the register it came from.
Which regulators recognise Biologici Italia Laboratories's GMP?
Current GMP certificates are on record from EMA and 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