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

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01 Alfacalcidol (1)

02 Calcipotriol (1)

03 Calcipotriol monohydrate (1)

04 Fusidic acid, Micronised (1)

05 Fusidic acid, Micronised, Process II (1)

06 Fusidic acid, Micronised, sterile (1)

07 Heparin sodium, For parenteral preparations, European and Chilean origin (1)

08 Heparin sodium, Potency not less than 180 IU/mg (with reference to the dried substance) From porcine origin, for parenteral preparations, Far East origin (1)

09 Sodium fusidate (1)

10 Sodium fusidate, Micronised (1)

11 Sodium fusidate, Micronised, Process II (1)

12 Sodium fusidate, Process II (1)

13 Sodium fusidate, Sterile (1)

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01 LEO PHARMA A/S Ballerup DK (12)

02 LEO PHARMACEUTICAL PRODUCTS LTD. A/S Ballerup DK (1)

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01 Denmark (13)

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01 Valid (11)

02 Withdrawn by Holder (2)

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LEO PHARMA A/S Ballerup...
Valid
R1-CEP 2007-286 - Rev 02
Chemical and TSE
2020-02-18
1286
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LEO PHARMA A/S Ballerup...
Valid
R1-CEP 2005-148 - Rev 01
Chemical
2013-03-13
2011
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LEO PHARMA A/S Ballerup...
Valid
R1-CEP 2005-145 - Rev 01
Chemical
2013-04-09
2284
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LEO PHARMA A/S Ballerup...
Valid
R1-CEP 2009-308 - Rev 02
Chemical
2022-01-19
798
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LEO PHARMA A/S Ballerup...
Valid
R0-CEP 2021-040 - Rev 01
Chemical
2022-01-19
798
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LEO PHARMA A/S Ballerup...
Valid
R1-CEP 2009-379 - Rev 00
Chemical
2016-10-21
798
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LEO PHARMA A/S Ballerup...
Valid
R1-CEP 2001-446 - Rev 03
Chemical
2020-02-21
333
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LEO PHARMACEUTICAL PROD...
Withdrawn by Holder
R1-CEP 2001-445 - Rev 02
Chemical
2011-03-30
2014-07-21
333
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LEO PHARMA A/S Ballerup...
Valid
R1-CEP 2009-309 - Rev 00
Chemical
2016-07-29
848
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LEO PHARMA A/S Ballerup...
Valid
R1-CEP 2009-317 - Rev 02
Chemical
2022-01-19
848
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