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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Alp Pharm Beijing Co Ltd to the U.S. FDA. Original Data : FDA Website

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01 (-)-ACYLFULVENE (1)

02 ABIRATERONE ACETATE (1)

03 ADAPALENE (DRUG SUBTANCE NON-STERILE) (1)

04 ADEFOVIR DIPIVOXIL (1)

05 ALOGLIPTIN BENZOATE (1)

06 ALPRAZOLAM USP (DRUG SUBSTANCE, NON-STERILE) (1)

07 ALVIMOPAN DIHYDRATE (2)

08 AMLODIPINE BESYLATE (DRUG SUBSTANCE, NON-STERILE) (1)

09 APIXABAN (1)

10 ARGATROBAN HYDRATE (1)

11 ATORVASTATION CALCIUM (DRUG SUBSTANCE, NON-STERILE) (1)

12 AZILSARTAN MEDOXOMIL (1)

13 BACITRACIN (1)

14 BACITRACIN ZINC (1)

15 BECLOMETHASONE DIPROPIONATE (1)

16 BESIFLOXACIN HYDROCHLORIDE (1)

17 BIVALIRUDIN (1)

18 BOSUTINIB (1)

19 BRINZOLAMIDE USP (DRUG SUBSTANCE, NON-STERILE) (1)

20 BROENAC SODIUM HYDRATE (1)

21 CALCIPOTRIENE (CALCIPOTRIOL) (1)

22 CALCIPOTRIENE HYDRATE (1)

23 CALCITONON SALMON (1)

24 CARISOPRODOL (DRUG SUBSTANCE, NON-STERILE) (1)

25 CETRORELIX ACETATE (1)

26 CICLESONIDE (1)

27 CIDOFOVIR DIHYDRATE (1)

28 CISATRACURIUM BESYLATE (1)

29 CLEVIDIPINE BUTYRATE (1)

30 CLOPIDOGREL BISULFATE FORM II (1)

31 D-METHIONINE (1)

32 D-PENICILLAMINE USP (1)

33 DALTEPARIN SODIUM (DRUG SUBSTANCE, NON-STERILE) (1)

34 DAPAGLIFLOZIN PROPANEDIOL (1)

35 DASATINIB (1)

36 DIFELIKEFALIN ACETATE (1)

37 DOXAPRAM HYDROCHLORIDE USP (1)

38 DOXERCALCIFEROL (1)

39 DRONEDARONE HYDROCHLORIDE (1)

40 ELOCALCITOL (1)

41 EMPAGLIFLOZIN (1)

42 EPO (RECOMBINANT HUMAN ERYTHROPOIETIN) (1)

43 EPTIFIBATIDE (1)

44 ERGOCALCIFEROL USP (1)

45 ESZOPICLONE (1)

46 EXENATIDE (1)

47 FEBUXOSTAT (1)

48 GOSERELIN ACETATE (1)

49 IOPROMIDE (1)

50 IRINOTECAN HYDROCHLORIDE (1)

51 ITRACONAZOLE (DRUG SUBSTANCE, NON-STERILE) (1)

52 LANREOTIDE ACETATE (1)

53 LAPATINIB DITOSYLATE (1)

54 LEUCOVORIN CALCIUM (1)

55 LEUPROLIDE ACETATE (1)

56 LIRAGLUTIDE (1)

57 LOTEPREDNOL ETABONATE (1)

58 LURASIDONE HYDROCHLORIDE (1)

59 LUTEIN (DRUG SUBSTANCE, NON-STERILE) (1)

60 MEPROBAMATE (DRUG SUBSTANCE, NON-STERILE) (1)

61 MESALAMINE (1)

62 MOXIFLOXACIN HYDROCHLORIDE (1)

63 NAPHAZOLINE HYDROCHLORIDE (DRUG SUBSTANCE, NON-STERILE) (1)

64 NAPHAZOLINE NITRATE (DRUG SUBSTANCE, NON-STERILE) (1)

65 NELARABINE (1)

66 NEPAFENAC (1)

67 OCTREOTIDE ACETATE (1)

68 OLAPARIB (1)

69 PALONOSETRON HYDROCHLORIDE (1)

70 PARICALCITOL USP (NON-STERILE DRUG SUBSTANCE) (1)

71 PLECANATIDE (1)

72 POLYMYXIN B SULFATE USP (1)

73 POSACONAZOLE FOMR I (1)

74 RISDIPLAM (1)

75 RIZATRIPTAN BENZOATE (1)

76 ROFLUMILAST (1)

77 ROSMARINIC ACID (DRUG SUBSTANCE, NON-STERILE) (1)

78 SEMAGLUTIDE (1)

79 SERTRALINE HYDROCHLORIDE (DRUG SUBSTANCE, NON-STERILE) (1)

80 SILODOSIN (1)

81 STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN CHARLOTTE, NC. (1)

82 STIRIPENTOL (1)

83 SULPIRIDE EP (1)

84 TAMSULOSIN HYDROCHLORIDE (1)

85 TAURINE (1)

86 TEDUGLUTIDE (1)

87 TRANEXAMIC ACID (1)

88 URSODEOXYCHOLIC ACID (DRUG SUBSTANCE NON-STERILE) (1)

89 VARENICLINE TARTRATE (1)

90 VERTEPORFIN (1)

91 VINORELBINE TARTRATE (1)

92 VORTIOXETINE HYDROBROMIDE (1)

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01 ALP PHARM ALLIANCEPHARM (1)

02 ALP PHARM BEIJING CO LTD (92)

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01 China (93)

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01 Active (52)

02 Inactive (41)

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01 Complete (7)

02 Blank (86)

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2010-01-30
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2010-10-21
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27993
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2014-05-19
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2008-09-01
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2012-04-02
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2010-07-26
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2008-09-01
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