Lek Pharmaceuticals
CEP Certificates (EDQM COS List)

Lek Pharmaceuticals

CEP Database

Certificates of Suitability to the European Pharmacopoeia (CEP), issued by the EDQM.

Chemical Slovenia
  • Total Records 20
  • Latest End Date 2025-04-16
  • Data Source EDQM
  • Last Updated 2024-10-21
All
20
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Valid
10
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Withdrawn
9
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Expired
1
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Company Overview

Company

Lek Pharmaceuticals

Country

Slovenia

Social Profiles

Company Snapshot

Lek Pharmaceuticals

Verovkova 57, 1526 Ljubljana

Slovenia

lek.si/en/ sandoz.b2b@sandoz.com View on Map
CEP Records Timeline (20 records)
2024
21 Oct
Chemical Valid

Product

Gentamicin sulfate

Substance

LEK PHARMACEUTICALS D.D. Ljubljana SI

Certificate No.

CEP 2005-121 - Rev 02

Substance No.

331

Issue Date

2024-10-21

End Date

-

Country

Slovenia

Identifiers

Certificate No.: CEP 2005-121 - Rev 02
Substance No.: 331

2024
16 Sep
Chemical Valid

Product

Mycophenolate mofetil, Process B

Substance

LEK PHARMACEUTICALS D.D. Ljubljana SI

Certificate No.

CEP 2011-317 - Rev 06

Substance No.

1700

Issue Date

2024-09-16

End Date

-

Country

Slovenia

Identifiers

Certificate No.: CEP 2011-317 - Rev 06
Substance No.: 1700

2023
07 Aug
Chemical Valid

Product

Tacrolimus monohydrate

Substance

LEK PHARMACEUTICALS D.D. Ljubljana SI

Certificate No.

R0-CEP 2021-204 - Rev 01

Substance No.

2244

Issue Date

2023-08-07

End Date

-

Country

Slovenia

Identifiers

Certificate No.: R0-CEP 2021-204 - Rev 01
Substance No.: 2244

2021
08 Mar
Chemical Valid

Product

Potassium clavulanate, diluted, with silica, colloidal hydrated in the ratio 1:1

Substance

LEK PHARMACEUTICALS D.D. Ljubljana SI

Certificate No.

R1-CEP 2007-260 - Rev 02

Substance No.

1653

Issue Date

2021-03-08

End Date

-

Country

Slovenia

Identifiers

Certificate No.: R1-CEP 2007-260 - Rev 02
Substance No.: 1653

2021
05 Mar
Chemical Valid

Product

Potassium clavulanate, diluted, with microcrystalline cellulose in the ratio 7:3

Substance

LEK PHARMACEUTICALS D.D. Ljubljana SI

Certificate No.

R1-CEP 2007-258 - Rev 02

Substance No.

1653

Issue Date

2021-03-05

End Date

-

Country

Slovenia

Identifiers

Certificate No.: R1-CEP 2007-258 - Rev 02
Substance No.: 1653

2021
05 Mar
Chemical Valid

Product

Potassium clavulanate, diluted, with microcrystalline cellulose in the ratio 1:1

Substance

LEK PHARMACEUTICALS D.D. Ljubljana SI

Certificate No.

R1-CEP 2007-259 - Rev 02

Substance No.

1653

Issue Date

2021-03-05

End Date

-

Country

Slovenia

Identifiers

Certificate No.: R1-CEP 2007-259 - Rev 02
Substance No.: 1653

2020
17 Jun
Chemical Valid

Product

Potassium clavulanate

Substance

LEK PHARMACEUTICALS D.D. Ljubljana SI

Certificate No.

R1-CEP 2003-262 - Rev 03

Substance No.

1140

Issue Date

2020-06-17

End Date

-

Country

Slovenia

Identifiers

Certificate No.: R1-CEP 2003-262 - Rev 03
Substance No.: 1140

2020
25 Feb
Chemical Valid

Product

Potassium clavulanate, Code Number 472803

Substance

LEK PHARMACEUTICALS D.D. Ljubljana SI

Certificate No.

R1-CEP 1998-001 - Rev 09

Substance No.

1140

Issue Date

2020-02-25

End Date

-

Country

Slovenia

Identifiers

Certificate No.: R1-CEP 1998-001 - Rev 09
Substance No.: 1140

2020
07 Feb
Chemical Valid

Product

Potassium clavulanate, diluted, with silica, colloidal hydrated in the ratio 1:1

Substance

LEK PHARMACEUTICALS D.D. Ljubljana SI

Certificate No.

R1-CEP 2004-241 - Rev 03

Substance No.

1653

Issue Date

2020-02-07

End Date

-

Country

Slovenia

Identifiers

Certificate No.: R1-CEP 2004-241 - Rev 03
Substance No.: 1653

2020
07 Feb
Chemical Valid

Product

Potassium clavulanate, diluted, with microcrystalline cellulose in a ratio of 1:1

Substance

LEK PHARMACEUTICALS D.D. Ljubljana SI

Certificate No.

R1-CEP 2004-242 - Rev 03

Substance No.

1653

Issue Date

2020-02-07

End Date

-

Country

Slovenia

Identifiers

Certificate No.: R1-CEP 2004-242 - Rev 03
Substance No.: 1653

2019
18 Dec
Chemical Withdrawn by Holder

Product

Vancomycin hydrochloride

Substance

LEK PHARMACEUTICALS D.D. Ljubljana SI

Certificate No.

R1-CEP 2004-179 - Rev 03

Substance No.

1058

Issue Date

2019-12-18

End Date

2025-04-16

Country

Slovenia

Identifiers

Certificate No.: R1-CEP 2004-179 - Rev 03
Substance No.: 1058

2019
15 Apr
Chemical Withdrawn by Holder

Product

Rosuvastatin calcium, Process C

Substance

LEK PHARMACEUTICALS D.D. Ljubljana SI

Certificate No.

R0-CEP 2016-321 - Rev 01

Substance No.

2631

Issue Date

2019-04-15

End Date

2024-01-05

Country

Slovenia

Identifiers

Certificate No.: R0-CEP 2016-321 - Rev 01
Substance No.: 2631

2016
13 Oct
Chemical Withdrawn by Holder

Product

Mycophenolate mofetil

Substance

LEK PHARMACEUTICALS D.D. Ljubljana SI

Certificate No.

R1-CEP 2005-222 - Rev 02

Substance No.

1700

Issue Date

2016-10-13

End Date

2018-04-03

Country

Slovenia

Identifiers

Certificate No.: R1-CEP 2005-222 - Rev 02
Substance No.: 1700

2013
18 Apr
Chemical Withdrawn by Holder

Product

Omeprazole

Substance

LEK PHARMACEUTICALS D.D. Ljubljana SI

Certificate No.

R1-CEP 2004-101 - Rev 02

Substance No.

942

Issue Date

2013-04-18

End Date

2015-06-09

Country

Slovenia

Identifiers

Certificate No.: R1-CEP 2004-101 - Rev 02
Substance No.: 942

2013
18 Apr
Chemical Expired

Product

Omeprazole, Process B

Substance

LEK PHARMACEUTICALS D.D. Ljubljana SI

Certificate No.

R0-CEP 2010-250 - Rev 01

Substance No.

942

Issue Date

2013-04-18

End Date

2016-02-11

Country

Slovenia

Identifiers

Certificate No.: R0-CEP 2010-250 - Rev 01
Substance No.: 942

2011
01 Jul
Chemical Withdrawn by Holder

Product

Amlodipine besilate

Substance

LEK PHARMACEUTICALS D.D. Ljubljana SI

Certificate No.

R1-CEP 2004-210 - Rev 00

Substance No.

1491

Issue Date

2011-07-01

End Date

2016-01-14

Country

Slovenia

Identifiers

Certificate No.: R1-CEP 2004-210 - Rev 00
Substance No.: 1491

2009
16 Apr
Chemical Withdrawn by Holder

Product

Simvastatin

Substance

LEK PHARMACEUTICALS D.D. Ljubljana SI

Certificate No.

R0-CEP 2005-089 - Rev 02

Substance No.

1563

Issue Date

2009-04-16

End Date

2010-10-04

Country

Slovenia

Identifiers

Certificate No.: R0-CEP 2005-089 - Rev 02
Substance No.: 1563

2009
14 Apr
Chemical Withdrawn by Holder

Product

Pravastatin sodium

Substance

LEK PHARMACEUTICALS D.D. Ljubljana SI

Certificate No.

R1-CEP 2003-025 - Rev 00

Substance No.

2059

Issue Date

2009-04-14

End Date

2013-11-19

Country

Slovenia

Identifiers

Certificate No.: R1-CEP 2003-025 - Rev 00
Substance No.: 2059

2008
12 Aug
Chemical Withdrawn by Holder

Product

Lisinopril dihydrate

Substance

LEK PHARMACEUTICALS D.D. Ljubljana SI

Certificate No.

R0-CEP 2006-065 - Rev 00

Substance No.

1120

Issue Date

2008-08-12

End Date

2012-12-13

Country

Slovenia

Identifiers

Certificate No.: R0-CEP 2006-065 - Rev 00
Substance No.: 1120

2007
07 Dec
Chemical Withdrawn by Holder

Product

Lovastatin

Substance

LEK PHARMACEUTICALS D.D. Ljubljana SI

Certificate No.

R0-CEP 2005-140 - Rev 00

Substance No.

1538

Issue Date

2007-12-07

End Date

2010-02-02

Country

Slovenia

Identifiers

Certificate No.: R0-CEP 2005-140 - Rev 00
Substance No.: 1538

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Status Breakdown
20 total
  • Valid
  • Withdrawn by holder
  • Expired
Official Source

All data is sourced from the official EDQM CEP database (Certification of Suitability to the European Pharmacopoeia).

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Record Details Preview

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Country

Slovenia

Identifiers

Certificate No.: CEP 2005-121 - Rev 02
Substance No.: 331

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CEP data is obtained from the official EDQM (European Directorate for the Quality of Medicines) database.

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