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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Zhejiang Hisun Pharmaceutical to the U.S. FDA. Original Data : FDA Website

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01 ACARBOSE USP (1)

02 ADENOSINE USP (1)

03 ANASTROZOLE USP (1)

04 APIXABAN (1)

05 ARIPIPRAZOLE USP (1)

06 ATORVASTATIN CALCIUM (1)

07 BICALUTAMIDE USP (1)

08 BLEOMYCIN A2 AND B2/COPPER COMPLEX, NON-STERILE BULK DRUG SUBSTANCE (1)

09 BLEOMYCIN SULFATE USP (1)

10 BLEOMYCIN SULFATE USP (PROCESS II) (1)

11 BORTEZOMIB (1)

12 CAPECITABINE USP (1)

13 CAPREOMYCIN SULFATE CONCENTRATE (1)

14 CAPREOMYCIN SULFATE USP (1)

15 CELECOXIB USP (1)

16 CHLORAMPHENICOL HEMISUCCINATE (1)

17 CLADRIBINE USP (1)

18 CLONAZEPAM, USP (1)

19 COMPACTIN (NON-STERILE, ACTIVE PHARMACEUTICAL INGREDIENT) (1)

20 CYCLOPHOSPHAMIDE USP (1)

21 CYTARABINE USP (1)

22 DABIGATRAN ETEXILATE MESYLATE (1)

23 DACTINOMYCIN USP (1)

24 DAPTOMYCIN (2)

25 DASATINIB (1)

26 DAUNORUBICIN HYDROCHLORIDE USP (1)

27 DECITABINE (1)

28 DEMECLOCYCLINE HYDROCHLORIDE USP (1)

29 DOCETAXEL TRIHYDRATE USP (1)

30 DONEPEZIL HYDROCHLORIDE USP (1)

31 DOXORUBICIN HYDROCHLORIDE USP (1)

32 DOXORUBICIN HYDROCHLORIDE USP (FERMENTATION) (1)

33 EPIRUBICIN HYDROCHLORIDE (1)

34 EPIRUBICIN HYDROCHLORIDE (LYOPHILIZED) NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT (1)

35 FAMCICLOVIR (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) (1)

36 FLOXURIDINE USP (1)

37 FLUDARABINE PHOSPHATE USP (1)

38 FLUVASTATIN SODIUM USP (1)

39 FR179642 (1)

40 GEFITINIB (1)

41 GEMCITABINE HYDROCHLORIDE USP (1)

42 GRANISETRON (1)

43 GRANISETRON HYDROCHLORIDE USP (1)

44 IDARUBICIN HYDROCHLORIDE USP (1)

45 IMATINIB MESYLATE (1)

46 IRINOTECAN HYDROCHLORIDE USP (1)

47 IVERMECTIN USP (1)

48 LETROZOLE USP (1)

49 LINEZOLID (1)

50 LOSARTAN POTASSIUM USP (1)

51 LOVASTATIN USP (1)

52 LURASIDONE HYDROCHLORIDE (1)

53 MEROPENEM STERILE (1)

54 MESNA USP (1)

55 METHOTREXATE USP (1)

56 MEVASTATIN (1)

57 MICAFUNGIN SODIUM (1)

58 MINOCYCLINE HYDROCHLORIDE USP (1)

59 MITOMYCIN USP (1)

60 MITOMYCIN USP (ALTERNATIVE PROCESS) (1)

61 MOXIFLOXACIN HYDROCHLORIDE USP (1)

62 MYCOPHENOLATE MOFETIL USP (2)

63 MYCOPHENOLIC ACID (1)

64 MYCOPHENOLIC ACID NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT (1)

65 OLANZAPINE USP (1)

66 ORLISTAT (1)

67 ORLISTAT USP (1)

68 OXALIPLATIN USP (1)

69 PALBOCICLIB (1)

70 PIOGLITAZONE HYDROCHLORIDE USP (1)

71 PITAVASTATIN CALCIUM (1)

72 PNEUMOCANDIN B0 (1)

73 PRAVASTATIN SODIUM (AMORPHOUS, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) (1)

74 PRAVASTATIN SODIUM USP (1)

75 PRAVASTATIN SODIUM USP (PROCESS II) (1)

76 PRAZIQUANTEL USP (1)

77 QUETIAPINE FUMARATE (1)

78 ROMIDEPSIN (1)

79 ROSUVASTATIN CALCIUM (1)

80 SIMVASTATIN (BHA ADDED) USP (1)

81 SIMVASTATIN USP (1)

82 SIROLIMUS (2)

83 SULBACTAM SODIUM USP (1)

84 TACROLIMUS (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) (1)

85 TACROLIMUS USP (1)

86 TAZOBACTAM SODIUM (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) (1)

87 TAZOBACTAM USP (1)

88 TICAGRELOR (1)

89 TIGECYCLINE USP (1)

90 TOBRAMYCIN (1)

91 TOLTERODINE TARTRATE, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT (1)

92 VALSARTAN USP (1)

93 VANCOMYCIN HYDROCHLORIDE USP (NON-STERILE, ACTIVE PHARMACEUTICAL INGREDIENT) (1)

94 VINBLASTINE SULFATE USP (1)

95 VINORELBINE TARTRATE USP (1)

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01 HISUN PHARMACEUTICAL HANGZHOU CO LTD (8)

02 HISUN PHARMACEUTICAL NANTONG CO LTD (5)

03 ZHEJIANG HISUN PHARMACEUTICAL CO LTD (85)

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01 China (98)

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01 Active (42)

02 Inactive (56)

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01 Complete (35)

02 Blank (63)

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ZHEJIANG HISUN PHARMA...
Active
19069
Complete
2012-11-23
2012-11-15
2005-12-14
II
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ZHEJIANG HISUN PHARMA...
Active
17306
Complete
2013-01-08
2012-12-18
2004-04-12
II
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ZHEJIANG HISUN PHARMA...
Active
25897
Complete
2013-06-25
2012-11-15
2012-03-31
II
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ZHEJIANG HISUN PHARMA...
Active
33298
N/A
2018-10-30
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ZHEJIANG HISUN PHARMA...
Active
28341
Complete
2014-08-07
2014-06-06
2014-06-11
II
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ZHEJIANG HISUN PHARMA...
Inactive
24325
N/A
2010-10-25
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ZHEJIANG HISUN PHARMA...
Active
17878
Complete
2013-01-08
2012-12-18
2004-12-03
II
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ZHEJIANG HISUN PHARMA...
Inactive
12814
N/A
1998-01-06
II
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ZHEJIANG HISUN PHARMA...
Inactive
12962
N/A
1998-04-24
II
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ZHEJIANG HISUN PHARMA...
Active
26312
Complete
2013-03-13
2012-11-15
2012-09-21
II
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