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

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01 Abacavir sulfate (1)

02 Aciclovir (1)

03 Adrenaline (1)

04 Adrenaline tartrate (1)

05 Allopurinol (1)

06 Alprazolam (1)

07 Amlodipine besilate (2)

08 Amlodipine besilate, Process C (1)

09 Aripiprazole (1)

10 Atazanavir sulfate (1)

11 Atenolol (1)

12 Atomoxetine hydrochloride (1)

13 Atorvastatin calcium (1)

14 Atovaquone (1)

15 Azathioprine (1)

16 Baclofen (1)

17 Betahistine dihydrochloride (1)

18 Candesartan cilexetil (1)

19 Candesartan cilexetil, Process II (1)

20 Capecitabine (1)

21 Carvedilol (1)

22 Celecoxib (1)

23 Cetirizine dihydrochloride (1)

24 Ciprofloxacin (1)

25 Ciprofloxacin Hydrochloride (1)

26 Citalopram hydrobromide (1)

27 Citalopram hydrobromide, Process II (1)

28 Citalopram hydrochloride (1)

29 Citalopram hydrochloride, Process II (1)

30 Clarithromycin (1)

31 Clopidogrel hydrogen sulfate (2)

32 Clopidogrel hydrogen sulfate, Process II (1)

33 Clozapine (1)

34 Dacarbazine (1)

35 Desloratadine (1)

36 Desmopressin (1)

37 Didanosine (1)

38 Dipyridamole (1)

39 Dipyridamole, Process II (1)

40 Duloxetine hydrochloride (1)

41 Enrofloxacin for veterinary use (1)

42 Enrofloxacin for veterinary use, Process II (1)

43 Escitalopram oxalate (1)

44 Escitalopram oxalate, Process II (1)

45 Esomeprazole magnesium trihydrate (1)

46 Esomeprazole magnesium trihydrate, ESQ process (1)

47 Febantel for veterinary use (1)

48 Fingolimod hydrochloride (1)

49 Fluconazole (1)

50 Flucytosine (2)

51 Fluticasone propionate (1)

52 Formoterol fumarate dihydrate (1)

53 Gabapentin (1)

54 Irbesartan (1)

55 Irbesartan, Process II (1)

56 Itraconazole (1)

57 Labetalol Hydrochloride (1)

58 Lamivudine (1)

59 Lamivudine, SVL Process (1)

60 Lamotrigine (1)

61 Lansoprazole (1)

62 Letrozole (1)

63 Levetiracetam (1)

64 Levofloxacin hemihydrate (1)

65 Lisinopril dihydrate (1)

66 Lopinavir (1)

67 Loratadine (1)

68 Losartan potassium (1)

69 Mirtazapine (1)

70 Mirtazapine, Hemihydrate (1)

71 Mirtazapine, Process-II (1)

72 Modafinil (1)

73 Montelukast sodium (1)

74 Moxifloxacin hydrochloride (1)

75 Nabumetone (1)

76 Nadolol (1)

77 Naproxen (1)

78 Nevirapine (1)

79 Nitrofurantoin (1)

80 Octreotide (1)

81 Olmesartan medoxomil (1)

82 Oxcarbazepine (1)

83 Oxybutynin hydrochloride (1)

84 Pantoprazole sodium sesquihydrate (1)

85 Paroxetine hydrochloride (1)

86 Paroxetine hydrochloride hemihydrate (1)

87 Perindopril tert-butylamine (1)

88 Pioglitazone hydrochloride (1)

89 Pramipexole dihydrochloride monohydrate (1)

90 Pregabalin (1)

91 Pregabalin, PEA Process (1)

92 Proguanil hydrochloride (1)

93 Propafenone hydrochloride (1)

94 Quetiapine Fumarate (1)

95 Quinapril hydrochloride (1)

96 Raltegravir potassium (1)

97 Risedronate sodium 2.5-hydrate (1)

98 Risperidone (1)

99 Ritonavir, Form-I (1)

100 Ritonavir, Form-I, RII process (1)

101 Ritonavir, Form-II (1)

102 Rivaroxaban, Modification-I (1)

103 Rivastigmine (1)

104 Rivastigmine hydrogen tartrate (1)

105 Rizatriptan benzoate (1)

106 Salmeterol xinafoate (1)

107 Sertraline hydrochloride (1)

108 Sertraline hydrochloride, Form II (1)

109 Sertraline hydrochloride, Process-II (1)

110 Sildenafil citrate (1)

111 Sodium alendronate trihydrate (1)

112 Sumatriptan succinate (1)

113 Tadalafil (1)

114 Tadalafil, Process II (1)

115 Telmisartan (1)

116 Temazepam (1)

117 Terbinafine hydrochloride (1)

118 Tiaprofenic acid (1)

119 Valaciclovir hydrochloride hydrate (1)

120 Valsartan (1)

121 Valsartan, Process II (1)

122 Valsartan, Process III (1)

123 Vardenafil hydrochloride trihydrate (1)

124 Venlafaxine hydrochloride (1)

125 Verapamil hydrochloride (1)

126 Voriconazole (1)

127 Zidovudine (2)

128 Zolmitriptan (1)

129 Zolpidem tartrate (1)

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01 MATRIX LABORATORIES (XIAMEN) LTD. Xiamen CN (1)

02 MYLAN LABORATORIES LIMITED Hyderabad IN (130)

03 VIATRIS SPECIALTY LLC Morgantown US (2)

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01 China (1)

02 India (2)

03 U.S.A (130)

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01 Valid (104)

02 Withdrawn by EDQM Failure to CEP procedure (1)

03 Withdrawn by Holder (28)

URL Supplier Web Content
MYLAN LABORATORIES LIMI...
Valid
R1-CEP 2013-141 - Rev 00
Chemical
2019-05-31
2589
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
MYLAN LABORATORIES LIMI...
Valid
R1-CEP 1998-029 - Rev 09
Chemical
2021-02-23
968
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
MYLAN LABORATORIES LIMI...
Valid
R1-CEP 2015-006 - Rev 00
Chemical
2021-11-30
2303
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
MYLAN LABORATORIES LIMI...
Valid
R1-CEP 2015-013 - Rev 01
Chemical
2021-09-28
254
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
MYLAN LABORATORIES LIMI...
Valid
R1-CEP 2000-015 - Rev 06
Chemical
2017-09-19
576
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
MYLAN LABORATORIES LIMI...
Valid
R1-CEP 2008-060 - Rev 01
Chemical
2018-08-01
1065
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
VIATRIS SPECIALTY LLC M...
Valid
CEP 2001-342 - Rev 04
Chemical
2024-01-03
1491
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
MYLAN LABORATORIES LIMI...
Valid
R1-CEP 2006-119 - Rev 03
Chemical
2018-01-08
1491
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
VIATRIS SPECIALTY LLC M...
Valid
CEP 2021-215 - Rev 01
Chemical
2024-01-04
1491
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
MYLAN LABORATORIES LIMI...
Valid
R1-CEP 2013-330 - Rev 01
Chemical
2021-09-02
2617
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US
PHARMACOMPASS
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your Marketing & Sales content
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