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List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Saneca Pharmaceuticals by EDQM. Original Data: EDQM Database

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01 Atorvastatin calcium (1)

02 Codeine phosphate hemihydrate (1)

03 Dihydrocodeine hydrogen tartrate (1)

04 Doxazosin mesilate (1)

05 Duloxetine hydrochloride (1)

06 Fentanyl citrate (1)

07 Hydromorphone hydrochloride, Milled (1)

08 Losartan potassium (1)

09 Methadone hydrochloride (1)

10 Metoprolol succinate (1)

11 Morphine hemisulfate 2.5-hydrate (1)

12 Naloxone hydrochloride dihydrate (1)

13 Naltrexone hydrochloride (1)

14 Oxycodone hydrochloride (1)

15 Pentoxifylline (1)

16 Pethidine hydrochloride, For use in the manufacture of parenteral preparations (1)

17 Pholcodine monohydrate (1)

18 Rivastigmine (1)

19 Rivastigmine hydrogen tartrate (1)

20 Rivastigmine hydrogen tartrate, Process 2 (1)

21 Terbinafine hydrochloride (1)

22 Tramadol hydrochloride (1)

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01 SANECA PHARMACEUTICALS A.S. Hlohovec SK (22)

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01 Slovakia (22)

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01 Expired (1)

02 Valid (18)

03 Withdrawn by Holder (3)

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SANECA PHARMACEUTICALS ...
Expired
R0-CEP 2015-271 - Rev 00
Chemical
2017-06-28
2022-08-01
2191
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SANECA PHARMACEUTICALS ...
Valid
R1-CEP 2007-023 - Rev 05
Chemical
2020-08-19
74
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SANECA PHARMACEUTICALS ...
Valid
R1-CEP 2008-018 - Rev 01
Chemical
2021-07-07
1776
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SANECA PHARMACEUTICALS ...
Valid
R1-CEP 2011-097 - Rev 02
Chemical
2020-12-17
2125
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SANECA PHARMACEUTICALS ...
Valid
R1-CEP 2014-297 - Rev 00
Chemical
2021-08-05
2594
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SANECA PHARMACEUTICALS ...
Valid
R1-CEP 2009-230 - Rev 00
Chemical
2016-07-13
1103
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SANECA PHARMACEUTICALS ...
Withdrawn by Holder
R1-CEP 2010-020 - Rev 00
Chemical
2016-06-28
2019-08-12
2232
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SANECA PHARMACEUTICALS ...
Valid
R1-CEP 2007-068 - Rev 01
Chemical
2018-09-07
408
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SANECA PHARMACEUTICALS ...
Withdrawn by Holder
R1-CEP 2007-022 - Rev 00
Chemical
2015-06-08
2022-11-30
1448
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CEP 2010-061 - Rev 03
Chemical
2023-12-19
1244
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