Suppliers / KRKA,d.d.,Novo mesto

KRKA,d.d.,Novo mesto

Slovenia 2 duplicate records merged Updated 9 July 2026

The public registers hold a second record for KRKA,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,d.d.,Novo mesto is an API and finished-dose manufacturer based in Slovenia. 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

Atazanavir finished dose Cobicistat finished dose Dabigatran finished dose Darunavir finished dose Edoxaban finished dose Enalapril finished dose Etoricoxib API Olmesartan finished dose Perindopril finished dose Perindopril Tert-Butylamine finished dose Pitavastatin finished dose Pomalidomide finished dose
Show 12 more molecule pages
Pramipexole finished dose Prasugrel finished dose Ramipril finished dose Repaglinide finished dose Ropinirole finished dose Sacubitril/Valsartan finished dose Tapentadol finished dose Vardenafil finished dose Vortioxetine finished dose Ziprasidone 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

Questions about KRKA,d.d.,Novo mesto

Does KRKA,d.d.,Novo mesto hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for KRKA,d.d.,Novo mesto. It does have 4,865 filings with 16 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does KRKA,d.d.,Novo mesto manufacture?
1 registered site is on record, in United Arab Emirates (Novo Mesto). Every site is listed on this page with the register it came from.
What does KRKA,d.d.,Novo mesto make?
3 molecules are on record against KRKA,d.d.,Novo mesto, including Etoricoxib, Memantine and Pantoprazole. Each links through to that molecule's full manufacturer list.
Where does KRKA,d.d.,Novo mesto file?
Filings are on record with AIFA (IT), FAMHP (BE), AEMPS (ES), MPA (SE) and 12 other regulators, 4,865 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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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