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

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

Slovenia Updated 9 July 2026

The public registers hold a second record for Krka, Tovarna Zdravil, D.D., Novo Mesto. The fuller profile, with 0 active US DMFs and 37 valid CEPs, is at Krka. Figures on this page cover only this record.

Krka, Tovarna Zdravil, D.D., Novo Mesto is an API and finished-dose 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

Dabigatran Etexilate Mesilate API Edoxaban finished dose Indapamide API Memantine API Atorvastatin API Rosuvastatin API Clopidogrel API Telmisartan API

Filings and GMP by regulator

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

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

Does Krka, Tovarna Zdravil, D.D., Novo Mesto hold a US DMF or a CEP?
Krka, Tovarna Zdravil, D.D., Novo Mesto holds 10 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, Tovarna Zdravil, D.D., Novo Mesto manufacture?
1 registered site is on record, in Slovenia (Mesto). Every site is listed on this page with the register it came from.
What does Krka, Tovarna Zdravil, D.D., Novo Mesto make?
9 molecules are on record against Krka, Tovarna Zdravil, D.D., Novo Mesto, including Norfloxacin, Atorvastatin Calcium, Clopidogrel Hydrochloride and Dabigatran Etexilate Mesilate. Each links through to that molecule's full manufacturer list.
Where does Krka, Tovarna Zdravil, D.D., Novo Mesto file?
Filings are on record with RAMA (GE), MPA (SE), BFARM (DE), EMA and 1 other regulator, 49 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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Sources on this page

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