Suppliers / Krka

Krka

Slovenia Updated 9 July 2026

Krka is an API and finished-dose manufacturer based in Slovenia. It holds 27 valid CEPs across a filed portfolio of 29 molecules. Its filings concentrate with MHRA (UK), DKMA (DK) and AIFA (IT).

0
active US DMFs
27
valid CEPs
1
registered plants
1,325
filings across 9 regulators

Registered plants

Site FDA FEI
Novo mesto Novo mesto, Slovenia Not on file

What they file, and where

Molecule Regulators Docs
Atorvastatin Calcium EDQM 2
Clopidogrel EDQM 2
Perindopril Tert-Butylamine EDQM 2
Rivaroxaban EDQM 2
Sildenafil Base SFDA (Saudi Arabia) 2
Telmisartan EDQM 2
Valsartan EDQM 2
Amlodipine EDQM 1
Amlodipine Besilate EDQM 1
Aripiprazole SFDA (Saudi Arabia) 1
Show all 29 molecules on file
Candesartan Cilexetil EDQM 1
Carvedilol EDQM 1
Donepezil SFDA (Saudi Arabia) 1
Duloxetine EDQM 1
Enalapril EDQM 1
Esomeprazole EDQM 1
Esomperazole SFDA (Saudi Arabia) 1
Levocetirizine Dihydrochloride SFDA (Saudi Arabia) 1
Losartan EDQM 1
Losartan Potassium EDQM 1
Olmesartan Medoxomil EDQM 1
Pantoprazole EDQM 1
Perindopril Erbumine SFDA (Saudi Arabia) 1
Rabeprazole EDQM 1
Rosuvastatin SFDA (Saudi Arabia) 1
Rosuvastatin Calcium EDQM 1
Ticagrelor EDQM 1
Venlafaxine EDQM 1
Vildagliptin SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Carvedilol API Enalapril API Eplerenone finished dose Levocetirizine API Olmesartan Medoxomil API Pramipexole finished dose Sildenafil API Amlodipine API Valsartan API Atorvastatin API Losartan API Rosuvastatin API
Show 9 more molecule pages
Clopidogrel API Esomeprazole API Venlafaxine API Pantoprazole API Telmisartan API Duloxetine API Rivaroxaban API Ticagrelor API Vildagliptin API

Filings and GMP by regulator

Regulator Filings GMP certificates
MHRA (UK) 506 None
DKMA (DK) 434 None
AIFA (IT) 195 None
ANSM (FR) 153 None
FDA (GH) 12 None
MPA (SE) 12 None

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability