Suppliers / Krka, Tovarna Zdravil, D.D., Novo Mesto

Krka, Tovarna Zdravil, D.D., Novo Mesto

Slovenia Updated 9 July 2026

Krka, Tovarna Zdravil, D.D., Novo Mesto is an API manufacturer based in Slovenia. It holds 10 valid CEPs across a filed portfolio of 9 molecules. Its filings concentrate with RAMA (GE), MPA (SE) and BFARM (DE).

0
active US DMFs
10
valid CEPs
1
registered plants
49
filings across 5 regulators

Registered plants

Site FDA FEI
mesto, Slovenia Not on file

What they file, and where

Molecule Regulators Docs
Norfloxacin EDQM 2
Atorvastatin Calcium EDQM 1
Clopidogrel Hydrochloride EDQM 1
Dabigatran Etexilate Mesilate EDQM 1
Dapagliflozin Propylene Glycol Monohydrate EDQM 1
Indapamide EDQM 1
Memantine EDQM 1
Rosuvastatin Calcium EDQM 1
Telmisartan EDQM 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
RAMA (GE) 30 None
MPA (SE) 9 None
BFARM (DE) 6 None
US FDA 2 None
EMA 2 None

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Sources on this page

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