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List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Sandoz B2b by EDQM. Original Data: EDQM Database

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01 Amlodipine besilate (1)

02 Amoxicillin sodium, Sterile (1)

03 Amoxicillin sodium, Sterile, process E (1)

04 Amoxicillin trihydrate, For veterinary purposes only, sterile (1)

05 Amoxicillin trihydrate, Material codes 472191, 472188, 472205, 451787, 440017, 440029, 452360 (1)

06 Amoxicillin trihydrate, Powder and for Direct Compression (1)

07 Ampicillin sodium, Sterile (1)

08 Ampicillin trihydrate, Powder and compacted (1)

09 Ampicillin, Powder, compacted (1)

10 Azithromycin, Monohydrate (1)

11 Benzylpenicillin (benzathine) tetrahydrate, Sterile, microfine, lecithin/polysorbate coated (1)

12 Benzylpenicillin (benzathine) tetrahydrate, ‘ FA Process’, sterile, lecithin and polysorbate 80 coated; Material Code Number (1)

13 Benzylpenicillin (procaine) monohydrate, Lecithin coated (1%), sterile (1)

14 Benzylpenicillin (procaine) monohydrate, Sterile, microfine (1)

15 Benzylpenicillin potassium, Sterile (1)

16 Benzylpenicillin sodium, Sterile (1)

17 Cefazolin sodium, Sterile (1)

18 Cefepime dihydrochloride monohydrate, Sterile (1)

19 Cefixime (2)

20 Cefixime, Alternative process (1)

21 Cefotaxime sodium, Sterile (2)

22 Cefpodoxime proxetil (1)

23 Cefpodoxime proxetil, Turbhe site (1)

24 Ceftazidime Pentahydrate, Sterile (1)

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

26 Ceftriaxone sodium, Sterile (2)

27 Cefuroxime axetil, Amorphous (1)

28 Clarithromycin, Powder and microfine (1)

29 Cloxacillin sodium, Powder, Compacted (1)

30 Cloxacillin sodium, Sterile (1)

31 Dicloxacillin sodium, Powder and compacted (1)

32 Erythromycin ethylsuccinate, Pulverised (1)

33 Erythromycin, Code number 4365000 (1)

34 Erythromycin, code number 4384000 (1)

35 Esomeprazole magnesium dihydrate (1)

36 Flucloxacillin sodium monohydrate, Ethyl acetate process; powder; compacted (1)

37 Gentamicin sulfate (1)

38 Imipenem monohydrate, Chemical synthesis, Sterile (1)

39 Lansoprazole (1)

40 Levothyroxine sodium, Code 460 187 - Code 460 132 (1)

41 Liothyronine sodium (1)

42 Lisinopril dihydrate (1)

43 Lovastatin (1)

44 Mycophenolate mofetil (1)

45 Mycophenolate mofetil, Process B (1)

46 Omeprazole (2)

47 Omeprazole magnesium (1)

48 Omeprazole sodium (1)

49 Omeprazole, Process B (1)

50 Pancreas powder, Powder-Granules-Granules F. From Porcine origin (1)

51 Pantoprazole sodium sesquihydrate (1)

52 Pantoprazole sodium sesquihydrate, Process 2 (1)

53 Phenoxymethylpenicillin (benzathine) tetrahydrate (1)

54 Phenoxymethylpenicillin potassium, Material Code Numbers 450401, 450402 and 451786 (1)

55 Potassium clavulanate (1)

56 Potassium clavulanate, Code Number 472803 (1)

57 Potassium clavulanate, Sterile (1)

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

59 Potassium clavulanate, diluted, with microcrystalline cellulose in a ratio of 3:2 (1)

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

61 Potassium clavulanate, diluted, with microcrystalline cellulose in the ratio 7:3 (1)

62 Potassium clavulanate, diluted, with silica, colloidal hydrated in the ratio 1:1 (2)

63 Pravastatin sodium (1)

64 Rabeprazole sodium (1)

65 Rosuvastatin calcium, Process C (1)

66 Roxithromycin, powder, microfine (1)

67 Sertraline hydrochloride (1)

68 Simvastatin (2)

69 Tacrolimus monohydrate (1)

70 Thiopental Sodium And Sodium Carbonate, Sterile (1)

71 Vancomycin hydrochloride (1)

72 Venlafaxine hydrochloride (1)

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01 LEK PHARMACEUTICALS D.D. Ljubljana SI (20)

02 SANDOZ GMBH Kundl AT (26)

03 SANDOZ INDUSTRIAL PRODUCTS S.A. Les Franqueses Del Vallès ES (4)

04 SANDOZ PRIVATE LIMITED Mahad IN (2)

05 SANDOZ PRIVATE LIMITED Navi Mumbai IN (5)

06 Sandoz Industrial Products S.A. Les Franqueses Del Vallès ES (8)

07 Sandoz Industrial Products SpA Rovereto IT (5)

08 Sandoz Syntek Ilaç Hammaddeleri Sanayi Ve Ticaret A.S. Istanbul TR (8)

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01 Austria (5)

02 Germany (47)

03 Slovenia (20)

04 Switzerland (6)

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01 Expired (5)

02 Valid (40)

03 Withdrawn by Holder (33)

URL Supplier Web Content
LEK PHARMACEUTICALS D.D...
Withdrawn by Holder
R1-CEP 2004-210 - Rev 00
Chemical
2011-07-01
2016-01-14
1491
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PHARMACOMPASS
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URL Supplier Web Content
SANDOZ GMBH Kundl AT
Valid
CEP 1998-058 - Rev 07
Chemical
2024-03-13
577
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URL Supplier Web Content
Sandoz Industrial Produ...
Valid
R1-CEP 1999-036 - Rev 09
Chemical
2022-09-09
577
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your Marketing & Sales content
URL Supplier Web Content
SANDOZ GMBH Kundl AT
Withdrawn by Holder
R0-CEP 2007-018 - Rev 02
Chemical
2013-05-28
2014-09-08
260
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URL Supplier Web Content
Sandoz Industrial Produ...
Valid
R2-CEP 1995-034 - Rev 06
Chemical
2015-11-12
260
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URL Supplier Web Content
SANDOZ GMBH Kundl AT
Valid
CEP 2023-277 - Rev 00
Chemical
2023-09-18
260
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URL Supplier Web Content
SANDOZ GMBH Kundl AT
Valid
CEP 1993-005 - Rev 08
Chemical
2024-02-20
578
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URL Supplier Web Content
Sandoz Industrial Produ...
Valid
R2-CEP 1995-035 - Rev 05
Chemical
2020-02-17
168
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URL Supplier Web Content
Sandoz Industrial Produ...
Valid
R1-CEP 1999-188 - Rev 03
Chemical
2018-01-15
167
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URL Supplier Web Content
SANDOZ INDUSTRIAL PRODU...
Withdrawn by Holder
R1-CEP 2002-257 - Rev 01
Chemical
2012-09-26
2023-07-20
1649
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