Suppliers / Novartis Farmacéutica, S. A

Novartis Farmacéutica, S. A

Spain Updated 9 July 2026

Novartis Farmacéutica, S. A is a finished-dose manufacturer based in Spain. It appears in 270 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with AEMPS (ES), EMA and ARCSA (EC). Its GMP standing is certified by NAFDAC (NG), EMA and AEMPS (ES).

0
active US DMFs
0
valid CEPs
2
registered plants
270
filings across 5 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
Barcelona, Spain Not on file
Barcelona, Spain Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
AEMPS (ES) 222 1
EMA 31 1
ARCSA (EC) 13 None
NAFDAC (NG) 3 1
MINSA (CR) 1 None

Questions about Novartis Farmacéutica, S. A

Does Novartis Farmacéutica, S. A hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Novartis Farmacéutica, S. A. It does have 270 filings with 5 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Novartis Farmacéutica, S. A manufacture?
2 registered sites are on record, in Spain (Barcelona among others). Every site is listed on this page with the register it came from.
Which regulators recognise Novartis Farmacéutica, S. A's GMP?
Current GMP certificates are on record from NAFDAC (NG), EMA and AEMPS (ES). 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