Krka
CEP Certificates (EDQM COS List)
Krka
CEP Database
Certificates of Suitability to the European Pharmacopoeia (CEP), issued by the EDQM.
- Total Records 34
- Latest End Date 2021-01-26
- Data Source EDQM
- Last Updated 2025-02-04
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CEP Records Timeline (34 records)
Product
Rabeprazole sodium hydrate
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
CEP 2018-140 - Rev 02
Substance No.
2331
Issue Date
2025-02-04
End Date
-
Country
Slovenia
Identifiers
Certificate No.: CEP 2018-140 - Rev 02
Substance No.: 2331
Product
Atorvastatin calcium, Micronised, non-micronised
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
CEP 2013-024 - Rev 02
Substance No.
2191
Issue Date
2025-01-07
End Date
-
Country
Slovenia
Identifiers
Certificate No.: CEP 2013-024 - Rev 02
Substance No.: 2191
Product
Clopidogrel hydrochloride
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
CEP 2018-251 - Rev 01
Substance No.
2791
Issue Date
2024-12-18
End Date
-
Country
Slovenia
Identifiers
Certificate No.: CEP 2018-251 - Rev 01
Substance No.: 2791
Product
Rosuvastatin calcium, Milled
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
CEP 2018-077 - Rev 03
Substance No.
2631
Issue Date
2024-11-04
End Date
-
Country
Slovenia
Identifiers
Certificate No.: CEP 2018-077 - Rev 03
Substance No.: 2631
Product
Valsartan, 319192
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
CEP 2024-137 - Rev 00
Substance No.
2423
Issue Date
2024-08-30
End Date
-
Country
Slovenia
Identifiers
Certificate No.: CEP 2024-137 - Rev 00
Substance No.: 2423
Product
Esomeprazole magnesium dihydrate, Micronised
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
CEP 2018-035 - Rev 03
Substance No.
2787
Issue Date
2024-04-30
End Date
-
Country
Slovenia
Identifiers
Certificate No.: CEP 2018-035 - Rev 03
Substance No.: 2787
Product
Ticagrelor, Micronized
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
CEP 2022-437 - Rev 00
Substance No.
3087
Issue Date
2024-03-01
End Date
-
Country
Slovenia
Identifiers
Certificate No.: CEP 2022-437 - Rev 00
Substance No.: 3087
Product
Candesartan cilexetil
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
CEP 2016-132 - Rev 01
Substance No.
2573
Issue Date
2024-02-19
End Date
-
Country
Slovenia
Identifiers
Certificate No.: CEP 2016-132 - Rev 01
Substance No.: 2573
Product
Losartan potassium, 318642
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
CEP 2023-323 - Rev 00
Substance No.
2232
Issue Date
2024-02-16
End Date
-
Country
Slovenia
Identifiers
Certificate No.: CEP 2023-323 - Rev 00
Substance No.: 2232
Product
Clopidogrel hydrogen sulfate
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
CEP 2014-027 - Rev 03
Substance No.
2531
Issue Date
2023-12-12
End Date
-
Country
Slovenia
Identifiers
Certificate No.: CEP 2014-027 - Rev 03
Substance No.: 2531
Product
Rivaroxaban
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
CEP 2021-231 - Rev 01
Substance No.
2932
Issue Date
2023-11-07
End Date
-
Country
Slovenia
Identifiers
Certificate No.: CEP 2021-231 - Rev 01
Substance No.: 2932
Product
Pantoprazole sodium sesquihydrate
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
R1-CEP 2013-227 - Rev 01
Substance No.
2296
Issue Date
2023-07-13
End Date
-
Country
Slovenia
Identifiers
Certificate No.: R1-CEP 2013-227 - Rev 01
Substance No.: 2296
Product
Telmisartan
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
R1-CEP 2015-307 - Rev 01
Substance No.
2154
Issue Date
2023-05-30
End Date
-
Country
Slovenia
Identifiers
Certificate No.: R1-CEP 2015-307 - Rev 01
Substance No.: 2154
Product
Rivaroxaban
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
R0-CEP 2021-232 - Rev 01
Substance No.
2932
Issue Date
2023-05-11
End Date
-
Country
Slovenia
Identifiers
Certificate No.: R0-CEP 2021-232 - Rev 01
Substance No.: 2932
Product
Valsartan
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
R1-CEP 2011-148 - Rev 04
Substance No.
2423
Issue Date
2023-01-27
End Date
-
Country
Slovenia
Identifiers
Certificate No.: R1-CEP 2011-148 - Rev 04
Substance No.: 2423
Product
Amlodipine besilate, 311302
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
R0-CEP 2022-449 - Rev 00
Substance No.
1491
Issue Date
2023-01-19
End Date
-
Country
Slovenia
Identifiers
Certificate No.: R0-CEP 2022-449 - Rev 00
Substance No.: 1491
Product
Losartan potassium
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
R0-CEP 2019-275 - Rev 00
Substance No.
2232
Issue Date
2022-03-17
End Date
-
Country
Slovenia
Identifiers
Certificate No.: R0-CEP 2019-275 - Rev 00
Substance No.: 2232
Product
Perindopril tert-butylamine, Code 301644
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
R0-CEP 2019-245 - Rev 01
Substance No.
2019
Issue Date
2022-03-07
End Date
-
Country
Slovenia
Identifiers
Certificate No.: R0-CEP 2019-245 - Rev 01
Substance No.: 2019
Product
Duloxetine hydrochloride
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
R1-CEP 2015-246 - Rev 00
Substance No.
2594
Issue Date
2022-03-01
End Date
-
Country
Slovenia
Identifiers
Certificate No.: R1-CEP 2015-246 - Rev 00
Substance No.: 2594
Product
Atorvastatin calcium, 315313
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
R0-CEP 2021-105 - Rev 01
Substance No.
2191
Issue Date
2022-01-28
End Date
-
Country
Slovenia
Identifiers
Certificate No.: R0-CEP 2021-105 - Rev 01
Substance No.: 2191
Product
Telmisartan, 315780
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
R0-CEP 2021-280 - Rev 00
Substance No.
2154
Issue Date
2021-11-30
End Date
-
Country
Slovenia
Identifiers
Certificate No.: R0-CEP 2021-280 - Rev 00
Substance No.: 2154
Product
Perindopril tert-butylamine, Code 302281
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
R0-CEP 2019-235 - Rev 00
Substance No.
2019
Issue Date
2021-09-22
End Date
-
Country
Slovenia
Identifiers
Certificate No.: R0-CEP 2019-235 - Rev 00
Substance No.: 2019
Product
Olmesartan medoxomil
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
R1-CEP 2015-259 - Rev 00
Substance No.
2600
Issue Date
2021-09-15
End Date
-
Country
Slovenia
Identifiers
Certificate No.: R1-CEP 2015-259 - Rev 00
Substance No.: 2600
Product
Amlodipine besilate
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
R1-CEP 2014-243 - Rev 01
Substance No.
1491
Issue Date
2021-05-11
End Date
-
Country
Slovenia
Identifiers
Certificate No.: R1-CEP 2014-243 - Rev 01
Substance No.: 1491
Product
Venlafaxine hydrochloride
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
R1-CEP 2005-264 - Rev 03
Substance No.
2119
Issue Date
2018-09-20
End Date
-
Country
Slovenia
Identifiers
Certificate No.: R1-CEP 2005-264 - Rev 03
Substance No.: 2119
Product
Carvedilol
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
R1-CEP 2001-294 - Rev 04
Substance No.
1745
Issue Date
2015-01-28
End Date
-
Country
Slovenia
Identifiers
Certificate No.: R1-CEP 2001-294 - Rev 04
Substance No.: 1745
Product
Norfloxacin
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
R1-CEP 2000-270 - Rev 04
Substance No.
1248
Issue Date
2013-03-14
End Date
2021-01-26
Country
Slovenia
Identifiers
Certificate No.: R1-CEP 2000-270 - Rev 04
Substance No.: 1248
Product
Simvastatin
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
R1-CEP 2006-298 - Rev 00
Substance No.
1563
Issue Date
2012-10-08
End Date
2017-09-13
Country
Slovenia
Identifiers
Certificate No.: R1-CEP 2006-298 - Rev 00
Substance No.: 1563
Product
Lovastatin
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
R1-CEP 2004-191 - Rev 01
Substance No.
1538
Issue Date
2010-12-02
End Date
2016-12-02
Country
Slovenia
Identifiers
Certificate No.: R1-CEP 2004-191 - Rev 01
Substance No.: 1538
Product
Enalapril maleate
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
R1-CEP 2000-212 - Rev 02
Substance No.
1420
Issue Date
2010-09-10
End Date
-
Country
Slovenia
Identifiers
Certificate No.: R1-CEP 2000-212 - Rev 02
Substance No.: 1420
Product
Bacitracin zinc
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
R0-CEP 2006-052 - Rev 00
Substance No.
466
Issue Date
2008-11-07
End Date
2013-11-19
Country
Slovenia
Identifiers
Certificate No.: R0-CEP 2006-052 - Rev 00
Substance No.: 466
Product
Oxytetracycline dihydrate
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
R1-CEP 1999-133 - Rev 01
Substance No.
199
Issue Date
2007-07-31
End Date
2007-10-25
Country
Slovenia
Identifiers
Certificate No.: R1-CEP 1999-133 - Rev 01
Substance No.: 199
Product
Simvastatin
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
R1-CEP 2001-212 - Rev 00
Substance No.
1563
Issue Date
2007-04-10
End Date
2009-06-01
Country
Slovenia
Identifiers
Certificate No.: R1-CEP 2001-212 - Rev 00
Substance No.: 1563
Product
Oxytetracycline dihydrate
Substance
KRKA, d.d., Novo mesto Novo mesto SI
Certificate No.
R0-CEP 2003-274 - Rev 00
Substance No.
199
Issue Date
2005-09-30
End Date
2007-10-25
Country
Slovenia
Identifiers
Certificate No.: R0-CEP 2003-274 - Rev 00
Substance No.: 199
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Status Breakdown
34 total- Valid
- Withdrawn by holder
Official Source
All data is sourced from the official EDQM CEP database (Certification of Suitability to the European Pharmacopoeia).
Visit EDQMRecord Details Preview
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Country
Slovenia
Identifiers
Certificate No.: CEP 2018-140 - Rev 02
Substance No.: 2331
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