Suppliers / KRKA,d.d.,Novo mesto

KRKA,d.d.,Novo mesto

United Arab Emirates 2 duplicate records merged Updated 9 July 2026

KRKA,d.d.,Novo mesto is an API and finished-dose manufacturer based in United Arab Emirates. It appears in 4,865 regulatory filings across 16 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), FAMHP (BE) and AEMPS (ES).

0
active US DMFs
0
valid CEPs
1
registered plants
4,865
filings across 16 regulators

Registered plants

Site FDA FEI
Novo mesto, United Arab Emirates Not on file

What they file, and where

Molecule Regulators Docs
Etoricoxib SFDA (Saudi Arabia) 1
Memantine SFDA (Saudi Arabia) 1
Pantoprazole SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Candesartan finished dose Dexketoprofen finished dose Enalapril finished dose Eplerenone finished dose Etoricoxib API Olmesartan finished dose Perindopril finished dose Pramipexole finished dose Ramipril finished dose Pantoprazole API Memantine API

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 2,195 None
FAMHP (BE) 713 None
AEMPS (ES) 519 None
MPA (SE) 493 None
INFARMED (PT) 438 None
RCETH (BY) 139 None

Comparing suppliers?

Choose your molecules and target markets. KRKA,d.d.,Novo mesto 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