Suppliers / Sanochemia Pharmazeutika

Sanochemia Pharmazeutika

Austria 78 employees 2 duplicate records merged Updated 9 July 2026

Sanochemia Pharmazeutika is an API and finished-dose manufacturer based in Austria. It holds one active US drug master file and 2 valid CEPs across a filed portfolio of 5 molecules. Its filings concentrate with UZPHARM (UZ), EMA and AIFA (IT). Its GMP standing is certified by UZPHARM (UZ), EMA and MFDS (Korea).

1
active US DMFs
2
valid CEPs
6
registered plants
189
filings across 13 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
2491 Neufeld an der Leitha, United Arab Emirates Not on file
Neufeld an der Leitha, Austria Not on file
Vienna, Austria Not on file
Burgenland, Austria Not on file
Tashkent, Uzbekistan Not on file
Tashkent Region, Uzbekistan Not on file

What they file, and where

Molecule Regulators Docs
Gadopentetate Dimeglumine SFDA (Saudi Arabia) 1
Gadoteric Acid SFDA (Saudi Arabia) 1
Galantamine US FDA 1
Galantamine Hydrobromide EDQM 1
Torasemide EDQM 1

Also appears on these molecule pages

Gadoteric Acid API Galantamine API Iopamidol finished dose Torasemide API

Filings and GMP by regulator

Regulator Filings GMP certificates
UZPHARM (UZ) 126 3
EMA 11 2
AIFA (IT) 10 None
EDE (AE) 7 None
MPA (SE) 6 None
FAMHP (BE) 5 None
MFDS (Korea) None 2

Questions about Sanochemia Pharmazeutika

Does Sanochemia Pharmazeutika hold a US DMF or a CEP?
Sanochemia Pharmazeutika holds 1 active US drug master file and 2 valid CEPs. 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.
Where does Sanochemia Pharmazeutika manufacture?
6 registered sites are on record, in United Arab Emirates, Austria and Uzbekistan (2491 Neufeld An Der Leitha, Neufeld An Der Leitha and Vienna among others). Every site is listed on this page with the register it came from.
What does Sanochemia Pharmazeutika make?
5 molecules are on record against Sanochemia Pharmazeutika, including Gadopentetate Dimeglumine, Gadoteric Acid, Galantamine and Galantamine Hydrobromide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Sanochemia Pharmazeutika's GMP?
Current GMP certificates are on record from UZPHARM (UZ), EMA and MFDS (Korea). 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