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), NCELS (KZ) and MINSA (CR). 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

Fentanyl API Hydromorphone API Morphine API Naltrexone API Tramadol API

Filings and GMP by regulator

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

Questions about Saneca Pharmaceuticals

Does Saneca Pharmaceuticals hold a US DMF or a CEP?
Saneca Pharmaceuticals holds 2 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Saneca Pharmaceuticals FDA-registered?
One site operated by Saneca Pharmaceuticals 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 Saneca Pharmaceuticals manufacture?
3 registered sites are on record, in United Arab Emirates and Slovakia (Hlohovec, Hlohovec and Slovakia). Every site is listed on this page with the register it came from.
What does Saneca Pharmaceuticals make?
5 molecules are on record against Saneca Pharmaceuticals, including Naltrexone, Fentanyl, Hydromorphone and Morphine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Saneca Pharmaceuticals's GMP?
Current GMP certificates are on record from EMA, EEC (Eurasian Economic Union) and ANVISA (Brazil). 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