Suppliers / Doppel Farmaceutici

Doppel Farmaceutici

Italy 396 employees Updated 9 July 2026

Doppel Farmaceutici is a finished-dose manufacturer based in Italy. It appears in 3 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with NCELS (KZ) and US FDA. Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 24 February 2023 as VAI.

0
active US DMFs
0
valid CEPs
6
registered plants 2 with an FDA FEI number
3
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
2 of 2 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

  • 24 February 2023 VAI US FDA
  • 17 June 2022 VAI US FDA

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

Registered plants

Site FDA FEI
Rozzano, United Arab Emirates Not on file
CORTEMAGGIORE, Italy Not on file
CORTEMAGGIORE (PC), Italy Not on file
Rozzano, Italy Not on file
Italy, Italy 3003877372
Italy, Italy 3004797574

Filings and GMP by regulator

Regulator Filings GMP certificates
NCELS (KZ) 2 None
US FDA 1 None
EMA None 5

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Open risk flags

  • The most recent inspection outcome was VAI, on 24 February 2023.

Sources on this page

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