Suppliers / Saneca Pharmaceuticals

Saneca Pharmaceuticals

Slovakia 174 employees 2 duplicate records merged Updated 9 July 2026

Saneca Pharmaceuticals is an API manufacturer based in Slovakia. It holds 2 active US drug master files across a filed portfolio of 5 molecules. Its filings concentrate with UZPHARM (UZ), MINSA (CR) and NCELS (KZ). Its GMP standing is certified by EMA, EAEU_EEC and ANVISA (Brazil).

2
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
5
filings across 3 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
Hlohovec, United Arab Emirates Not on file
HLOHOVEC, Slovakia Not on file
Slovakia, Slovakia 3011324289

What they file, and where

Molecule Regulators Docs
Naltrexone US FDA 2
Fentanyl SFDA (Saudi Arabia) 1
Hydromorphone SFDA (Saudi Arabia) 1
Morphine SFDA (Saudi Arabia) 1
Tramadol SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
UZPHARM (UZ) 3 None
MINSA (CR) 1 None
NCELS (KZ) 1 None
EMA None 4
EAEU_EEC None 1
ANVISA (Brazil) None 1

Comparing suppliers?

Choose your molecules and target markets. Saneca Pharmaceuticals comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Sources on this page

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