Suppliers / Genetic S. P. A

Genetic S. P. A

Italy Updated 9 July 2026

Genetic S. P. A is a finished-dose manufacturer based in Italy. It appears in 663 regulatory filings across 11 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), EMA and INFARMED (PT). Its GMP standing is certified by EMA.

0
active US DMFs
0
valid CEPs
3
registered plants
663
filings across 11 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
Fisciano, United Arab Emirates Not on file
FISCIANO, Italy Not on file
Fisciano, Italy Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 520 None
EMA 100 1
INFARMED (PT) 21 None
FAMHP (BE) 5 None
AEMPS (ES) 4 None
MPA (SE) 3 None

Questions about Genetic S. P. A

Does Genetic S. P. A hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Genetic S. P. A. It does have 663 filings with 11 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Genetic S. P. A manufacture?
3 registered sites are on record, in United Arab Emirates and Italy (Fisciano and Fisciano among others). Every site is listed on this page with the register it came from.
Which regulators recognise Genetic S. P. A'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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Sources on this page

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