Suppliers / Krka

Krka

Slovenia reconciled across 31 public records · 14 entities Updated 9 July 2026

Krka is an API and finished-dose manufacturer based in Slovenia. It holds 37 valid CEPs. Its filings concentrate with AIFA (IT), FAMHP (BE) and INFARMED (PT).

0
active US DMFs
37
valid CEPs
6
registered plants
6,609
filings across 23 regulators

Registered plants

Site FDA FEI
Novo mesto, United Arab Emirates Not on file
Sintra, Portugal Not on file
SINTRA, Portugal Not on file
Terrugem, Portugal Not on file
mesto, Slovenia Not on file
Novo mesto Novo mesto, Slovenia Not on file

What they file, and where

Molecule Regulators Docs
Atorvastatin Calcium EDQM 3
Telmisartan EDQM 3
Clopidogrel EDQM 2
Memantine EDQM, SFDA (Saudi Arabia) 2
Norfloxacin EDQM 2
Olmesartan Medoxomil EDQM, SFDA (Saudi Arabia) 2
Pantoprazole EDQM, SFDA (Saudi Arabia) 2
Perindopril Tert-Butylamine EDQM 2
Rivaroxaban EDQM 2
Rosuvastatin Calcium EDQM 2
Show all 36 molecules on file
Sildenafil Base SFDA (Saudi Arabia) 2
Valsartan EDQM 2
Amlodipine EDQM 1
Amlodipine Besilate EDQM 1
Aripiprazole SFDA (Saudi Arabia) 1
Candesartan Cilexetil EDQM 1
Carvedilol EDQM 1
Clopidogrel Hydrochloride EDQM 1
Dabigatran Etexilate Mesilate EDQM 1
Dapagliflozin Propylene Glycol Monohydrate EDQM 1
Donepezil SFDA (Saudi Arabia) 1
Duloxetine EDQM 1
Enalapril EDQM 1
Esomeprazole EDQM 1
Esomperazole SFDA (Saudi Arabia) 1
Etoricoxib SFDA (Saudi Arabia) 1
Indapamide EDQM 1
Levocetirizine Dihydrochloride SFDA (Saudi Arabia) 1
Losartan EDQM 1
Losartan Potassium EDQM 1
Perindopril Erbumine SFDA (Saudi Arabia) 1
Rabeprazole EDQM 1
Rosuvastatin SFDA (Saudi Arabia) 1
Ticagrelor EDQM 1
Venlafaxine EDQM 1
Vildagliptin SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Atazanavir finished dose Candesartan Cilexetil API Carvedilol API Cobicistat finished dose Dabigatran Etexilate Mesilate finished dose Elvitegravir finished dose Enalapril API Esomperazole API Levocetirizine API Olmesartan Medoxomil API Pemetrexed Disodium finished dose Perindopril Tert-Butylamine API
Show 21 more molecule pages
Prasugrel finished dose Rabeprazole API Sildenafil API Tapentadol finished dose Ziprasidone finished dose Amlodipine API Valsartan API Atorvastatin API Losartan API Rosuvastatin API Clopidogrel API Esomeprazole API Venlafaxine API Pantoprazole API Telmisartan API Duloxetine API Rivaroxaban API Ticagrelor API Vildagliptin API Aripiprazole API Donepezil API

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 2,390 None
FAMHP (BE) 713 None
INFARMED (PT) 623 None
AEMPS (ES) 519 None
MPA (SE) 514 None
MHRA (UK) 506 None

Questions about Krka

Does Krka hold a US DMF or a CEP?
Krka holds 37 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 Krka manufacture?
6 registered sites are on record, in United Arab Emirates, Portugal and Slovenia (Novo Mesto, Sintra and Sintra among others). Every site is listed on this page with the register it came from.
What does Krka make?
36 molecules are on record against Krka, including Atorvastatin Calcium, Telmisartan, Clopidogrel and Memantine. Each links through to that molecule's full manufacturer list.
Where does Krka file?
Filings are on record with AIFA (IT), FAMHP (BE), INFARMED (PT), AEMPS (ES) and 19 other regulators, 6,609 in total.

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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Comparable suppliers

Apitoria Pharma shares 5 molecules Dr Reddy's Laboratories shares 5 molecules Macleods Pharmaceuticals shares 5 molecules Alivus Life Sciences shares 4 molecules Zhejiang Huahai Pharmaceutical shares 4 molecules

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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