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

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01 Abacavir sulfate (1)

02 Aciclovir (1)

03 Allopurinol (1)

04 Amlodipine besilate (1)

05 Amlodipine besilate, Process II (1)

06 Anastrozole (1)

07 Aprepitant (1)

08 Aripiprazole, Process-II (1)

09 Aripiprazole, Type-I (1)

10 Atazanavir sulfate (1)

11 Atomoxetine hydrochloride (1)

12 Atomoxetine hydrochloride, Process-II (1)

13 Atorvastatin calcium, Form-I (1)

14 Atovaquone, Form A (1)

15 Bicalutamide, Form-H1 (1)

16 Candesartan cilexetil (1)

17 Capecitabine (1)

18 Carbidopa (1)

19 Carboplatin (1)

20 Celecoxib (1)

21 Cilazapril (1)

22 Cisplatin (1)

23 Citalopram hydrobromide (1)

24 Citalopram hydrobromide, CTP Process (1)

25 Cyclophosphamide monohydrate (1)

26 Desloratadine (1)

27 Docetaxel trihydrate (1)

28 Donepezil hydrochloride monohydrate, Monohydrate (1)

29 Dorzolamide hydrochloride (1)

30 Duloxetine hydrochloride (1)

31 Dutasteride (1)

32 Entacapone (1)

33 Entecavir monohydrate (1)

34 Eplerenone (1)

35 Escitalopram oxalate, Process I (1)

36 Escitalopram oxalate, Process II (1)

37 Esomeprazole magnesium dihydrate (1)

38 Esomeprazole magnesium trihydrate (1)

39 Famotidine (1)

40 Fenofibrate (1)

41 Fexofenadine hydrochloride (1)

42 Finasteride (1)

43 Fosinopril sodium (1)

44 Gabapentin (1)

45 Gefitinib (1)

46 Gemcitabine hydrochloride (1)

47 Gemcitabine hydrochloride, GA process (1)

48 Glimepiride (1)

49 Hydralazine hydrochloride (1)

50 Imatinib mesilate, Form α, Process II (1)

51 Imatinib mesilate, Form-α (1)

52 Imatinib mesilate, Form-β (1)

53 Indometacin (1)

54 Irbesartan (1)

55 Irinotecan hydrochloride trihydrate, Form-B (1)

56 Isotretinoin (1)

57 Itraconazole (1)

58 Lacosamide (1)

59 Lamivudine (1)

60 Lamivudine, LAN process, Form II (1)

61 Lamivudine, LML Process (1)

62 Lansoprazole (1)

63 Lansoprazole, LANCO Process (1)

64 Letrozole (1)

65 Levetiracetam, Form I, LET Process (1)

66 Levetiracetam, Form-I (1)

67 Levetiracetam, Form-I Process-II (1)

68 Levodopa (1)

69 Levofloxacin hemihydrate (1)

70 Lisinopril dihydrate (1)

71 Lisinopril dihydrate, Process II (1)

72 Lisinopril dihydrate, Process-III (1)

73 Lopinavir (1)

74 Losartan potassium, Form I (1)

75 Mexiletine hydrochloride (1)

76 Mirtazapine (1)

77 Montelukast sodium (1)

78 Moxifloxacin hydrochloride (1)

79 Nebivolol hydrochloride (1)

80 Nevirapine (1)

81 Nevirapine, Additional site (1)

82 Olanzapine, Form-I (1)

83 Olanzapine, Form-I, Process II (1)

84 Olmesartan medoxomil (1)

85 Omeprazole magnesium (1)

86 Omeprazole, Form-B (1)

87 Omeprazole, Process II (1)

88 Oseltamivir phosphate (1)

89 Oxaliplatin (1)

90 Paclitaxel, Produced by a semi-synthetic process (1)

91 Pantoprazole sodium sesquihydrate (1)

92 Perindopril tert-butylamine (1)

93 Pioglitazone hydrochloride (1)

94 Pioglitazone hydrochloride, Process II (1)

95 Pramipexole dihydrochloride monohydrate (1)

96 Pregabalin (1)

97 Pregabalin, Process II (1)

98 Proguanil hydrochloride (1)

99 Quetiapine Fumarate (1)

100 Quetiapine Fumarate, Process III (1)

101 Raloxifene hydrochloride (1)

102 Ramipril (1)

103 Ramipril, Process-II (1)

104 Ritonavir, Form-I (1)

105 Rizatriptan benzoate (1)

106 Rosuvastatin calcium (1)

107 Sertraline hydrochloride (1)

108 Sertraline hydrochloride, Alternate process (1)

109 Sertraline hydrochloride, Form-I (1)

110 Sertraline hydrochloride, Form-II, Process-II (1)

111 Sildenafil citrate (1)

112 Simvastatin (1)

113 Solifenacin succinate (1)

114 Sorafenib tosilate (1)

115 Stavudine (1)

116 Telmisartan (2)

117 Temozolomide, FORM-III (1)

118 Terbinafine hydrochloride (1)

119 Terbinafine hydrochloride, Process II (1)

120 Tolterodine tartrate (1)

121 Topiramate (1)

122 Torasemide (1)

123 Valaciclovir hydrochloride hydrate (1)

124 Valaciclovir hydrochloride hydrate, Site-II (1)

125 Valganciclovir hydrochloride (1)

126 Valganciclovir hydrochloride, Site-II (1)

127 Valsartan (1)

128 Valsartan, Process III (1)

129 Valsartan, Process-II (1)

130 Valsartan, VL Process (1)

131 Venlafaxine hydrochloride (1)

132 Voriconazole, Form-I (1)

133 Voriconazole, Form-I VZ Process (1)

134 Zidovudine (1)

135 Ziprasidone hydrochloride monohydrate (1)

136 Zoledronic acid monohydrate (1)

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01 HETERO DRUGS LIMITED Hyderabad IN (68)

02 HETERO LABS LIMITED Hyderabad IN (69)

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01 India (137)

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01 Valid (118)

02 Withdrawn by Holder (19)

URL Supplier Web Content
HETERO LABS LIMITED Hyd...
Valid
R1-CEP 2016-090 - Rev 00
Chemical
2023-01-27
2589
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PHARMACOMPASS
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your Marketing & Sales content
URL Supplier Web Content
HETERO DRUGS LIMITED Hy...
Valid
CEP 2012-090 - Rev 02
Chemical
2024-05-21
968
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PHARMACOMPASS
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your Marketing & Sales content
URL Supplier Web Content
HETERO DRUGS LIMITED Hy...
Valid
R0-CEP 2021-074 - Rev 01
Chemical
2023-08-11
576
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PHARMACOMPASS
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your Marketing & Sales content
URL Supplier Web Content
HETERO DRUGS LIMITED Hy...
Valid
R1-CEP 2006-003 - Rev 04
Chemical
2018-04-12
1491
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PHARMACOMPASS
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your Marketing & Sales content
URL Supplier Web Content
HETERO DRUGS LIMITED Hy...
Valid
R1-CEP 2016-077 - Rev 00
Chemical
2021-10-29
1491
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PHARMACOMPASS
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your Marketing & Sales content
URL Supplier Web Content
HETERO LABS LIMITED Hyd...
Valid
R1-CEP 2013-172 - Rev 01
Chemical
2020-12-15
2406
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your Marketing & Sales content
URL Supplier Web Content
HETERO DRUGS LIMITED Hy...
Valid
CEP 2017-196 - Rev 02
Chemical
2024-03-01
2757
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PHARMACOMPASS
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URL Supplier Web Content
HETERO LABS LIMITED Hyd...
Valid
R0-CEP 2017-254 - Rev 02
Chemical
2022-06-01
2617
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PHARMACOMPASS
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your Marketing & Sales content
URL Supplier Web Content
HETERO LABS LIMITED Hyd...
Valid
R1-CEP 2013-361 - Rev 01
Chemical
2022-06-02
2617
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PHARMACOMPASS
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your Marketing & Sales content
URL Supplier Web Content
HETERO LABS LIMITED Hyd...
Valid
R0-CEP 2019-217 - Rev 00
Chemical
2023-06-13
2898
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