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List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Fresenius Se & Co. Kgaa by EDQM. Original Data: EDQM Database

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01 Amoxicillin sodium (1)

02 Ampicillin sodium (1)

03 Ampicillin sodium, Sterile (1)

04 Bacampicillin Hydrochloride (1)

05 Bicalutamide (1)

06 Buflomedil Hydrochloride (1)

07 Busulfan (1)

08 Carboplatin (1)

09 Cefalotin sodium, Sterile (1)

10 Cefatrizine propylene glycol (1)

11 Cefazolin sodium, Sterile, process A (1)

12 Cefazolin sodium, sterile, process B (1)

13 Cefepime dihydrochloride monohydrate, Sterile (1)

14 Cefepime dihydrochloride monohydrate, Sterile, process 2 (1)

15 Cefoperazone sodium, Sterile (1)

16 Cefotaxime sodium, Sterile (1)

17 Cefoxitin sodium, Sterile (1)

18 Ceftazidime Pentahydrate, Sterile (1)

19 Ceftazidime pentahydrate with sodium carbonate for injection, Sterile (1)

20 Ceftriaxone sodium (1)

21 Ceftriaxone sodium, Sterile (2)

22 Cefuroxime sodium, Sterile (1)

23 Cisplatin (1)

24 Cloxacillin sodium, Powder and compacted (1)

25 Cloxacillin sodium, Sterile (1)

26 Dicloxacillin sodium, Powder and compacted (1)

27 Dicloxacillin sodium, sterile (1)

28 Docetaxel (1)

29 Docetaxel trihydrate (1)

30 Flucloxacillin sodium monohydrate, Powder and compacted (1)

31 Flucloxacillin sodium monohydrate, Sterile (1)

32 Gemcitabine hydrochloride (1)

33 Gemcitabine hydrochloride, Alternate Process-2 (1)

34 Gemcitabine hydrochloride, Alternate process (1)

35 Irinotecan hydrochloride trihydrate (1)

36 Lactulose (1)

37 Lactulose, liquid (1)

38 Lactulose, liquid, 667 g/L (1)

39 Lactulose, liquid, 670 g/l (1)

40 Lactulose, liquid, with sodium benzoate (1)

41 Letrozole (1)

42 Oxaliplatin (1)

43 Paclitaxel, Semi-synthetic process (1)

44 Piperacillin monohydrate (1)

45 Piperacillin sodium, Sterile (1)

46 Pivmecillinam hydrochloride (1)

47 Ropivacaine hydrochloride monohydrate (1)

48 Ropivacaine hydrochloride monohydrate, Alternate process (1)

49 Starches, hydroxyethyl, Mw 200, MS 0.5, C2/C6 6 (1)

50 Starches, hydroxyethyl, Mw 450, MS 0.7, C2/C6 5 (1)

51 Sulbactam sodium, Sterile (1)

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01 FRESENIUS KABI Anti-Infectives S.r.l. Cernusco sul Naviglio IT (2)

02 FRESENIUS KABI IPSUM S.R.L. Cassina de’ Pecchi IT (22)

03 FRESENIUS KABI IPSUM S.R.L. Cassina de’Pecchi IT (2)

04 FRESENIUS KABI IPSUM S.R.L. Cernusco sul Naviglio IT (1)

05 FRESENIUS KABI ONCOLOGY LIMITED Kalyani IN (16)

06 Fresenius Kabi Austria GmbH Linz AT (7)

07 Ribbon S.r.l. Milano IT (2)

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01 Austria (7)

02 Germany (4)

03 India (16)

04 Italy (22)

05 Sweden (3)

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01 Expired (2)

02 Valid (40)

03 Withdrawn by Holder (10)

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FRESENIUS KABI IPSUM S....
Valid
R1-CEP 2008-267 - Rev 07
Chemical
2022-10-11
577
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FRESENIUS KABI IPSUM S....
Valid
CEP 2012-224 - Rev 05
Chemical
2024-02-20
578
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FRESENIUS KABI IPSUM S....
Valid
R1-CEP 2007-227 - Rev 04
Chemical
2021-02-11
578
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FRESENIUS KABI IPSUM S....
Valid
R1-CEP 2004-188 - Rev 06
Chemical
2022-10-10
808
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FRESENIUS KABI ONCOLOGY...
Valid
R1-CEP 2012-369 - Rev 00
Chemical
2021-05-20
2196
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FRESENIUS KABI ONCOLOGY...
Withdrawn by Holder
R0-CEP 2010-346 - Rev 00
Chemical
2013-04-04
2015-11-24
1398
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FRESENIUS KABI ONCOLOGY...
Valid
CEP 2010-374 - Rev 07
Chemical
2023-10-13
542
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FRESENIUS KABI ONCOLOGY...
Valid
R1-CEP 2001-282 - Rev 13
Chemical
2022-03-07
1081
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FRESENIUS KABI IPSUM S....
Withdrawn by Holder
R1-CEP 2004-227 - Rev 03
Chemical
2019-04-24
2022-01-14
987
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FRESENIUS KABI IPSUM S....
Withdrawn by Holder
R1-CEP 1999-142 - Rev 05
Chemical
2019-04-24
2022-02-09
1403
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