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

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01 ALENDRONATE SODIUM USP (1)

02 ALLOPURINOL USP (1)

03 AMLODIPINE BESYLATE USP (1)

04 AMODIAQUINE HYDROCHLORIDE USP (1)

05 ARTEMETHER (1)

06 ARTESUNATE (1)

07 ATENOLOL (1)

08 ATENOLOL USP (1)

09 BALSALAZIDE DISODIUM DIHYDRATE (1)

10 BENDROFLUMETHIAZIDE USP (1)

11 BISOPROLOL FUMARATE USP (1)

12 BISOPROLOL FUMARATE USP (PROCESS II) (1)

13 CARVEDILOL USP (1)

14 CETIRIZINE HYDROCHLORIDE USP (1)

15 CETIRIZINE HYDROCHLORIDE USP (CZ5 PROCESS) (1)

16 CHLOROQUINE PHOSPHATE USP (1)

17 CHLORTHALIDONE USP (1)

18 CHLORTHALIDONE USP (CT6 PROCESS) (1)

19 CILOSTAZOL USP (1)

20 CITALOPRAM HYDROBROMIDE USP (1)

21 CLOPIDOGREL BISULFATE (FORM 1) USP (PROCESS-II) (1)

22 CLOPIDOGREL BISULFATE USP (XC4 PROCESS) (1)

23 CLOPIDOGREL BISULFATE USP FORM 1 (1)

24 ERTHROMYCIN ESTOLATE (1)

25 ESCITALOPRAM OXALATE (1)

26 ETODOLAC (1)

27 ETODOLAC USP (ED6 PROCESS) (1)

28 ETODOLAC USP (ED7 PROCESS) (1)

29 FACILITY FOR BULK DRUG PRODUCTION IN INDORE INDIA (1)

30 FACILITY IBD-D IN PIN., INDIA (1)

31 FENOFIBRATE USP (1)

32 FLUCONAZOLE USP (1)

33 FLUCONAZOLE USP (G3 PROCESS) (1)

34 FLUMEQUINE (1)

35 FUROSEMIDE USP (1)

36 GLIMEPIRIDE USP (1)

37 HYDROCHLOROTHIAZIDE USP (1)

38 HYDROCHLOROTHIAZIDE USP, PROCESS II (1)

39 HYDROXYCHLOROQUINE SULFATE USP (1)

40 HYDROXYZINE HYDROCHLORIDE USP (1)

41 IBD-IV MANUFACTURING FACILITY IN RATLAM, INDIA (1)

42 INDAPAMIDE USP (1)

43 ISOTRETINOIN USP (1)

44 LISINOPRIL (1)

45 LOSARTAN POTASSIUM (1)

46 LOSARTAN POTASSIUM USP (PROCESS II) (1)

47 LUMEFANTRINE (1)

48 Losartan Potassium USP (LB5 Process) (1)

49 MESALAMINE USP (1)

50 MESALAMINE USP (MZ3 PROCESS) (1)

51 MESALAMINE USP (PROCESS II) (1)

52 METFORMIN HYDROCHLORIDE USP (1)

53 METFORMIN HYDROCHLORIDE USP (PROCESS-II) (1)

54 METHYLPHENIDATE HYDROCHLORIDE USP (1)

55 METOCLOPRAMIDE HCL USP (1)

56 METOPROLOL SUCCINATE (1)

57 METOPROLOL SUCCINATE USP (PROCESS-II) (1)

58 METOPROLOL TARTRATE USP (1)

59 METOPROLOL TARTRATE USP (PROCESS III) (1)

60 MIDODRINE HYDROCHLORIDE USP (1)

61 NABUMETONE (1)

62 NABUMETONE USP, PROCESS II (1)

63 OLANZAPINE USP (1)

64 ONDANSETRON HYDROCHLORIDE USP (1)

65 ONDANSETRON USP (1)

66 PANTOPRAZOLE SODIUM USP (1)

67 PAROXETINE HYDROCHLORIDE (1)

68 PENTOXIFYLLINE (1)

69 PERINDOPRIL TERT-BUTYLAMINE PH EUR (1)

70 PRIMAQUINE PHOSPHATE USP (1)

71 PROBENECID USP (1)

72 PROGUANIL HYDROCHLORIDE USP (1)

73 PROMETHAZINE HYDROCHLORIDE USP (1)

74 PROPRANOLOL HYDROCHLORIDE USP (1)

75 PYRANTEL PAMOATE USP (1)

76 PYRANTEL TARTRATE (1)

77 PYRIMETHAMINE USP (1)

78 QUETIAPINE HEMIFUMARATE (1)

79 RISEDRONATE SODIUM HEMI-PENTAHYDRATE USP (2)

80 RISPERIDONE USP (1)

81 RITALINIC ACID (1)

82 SULFADOXINE (1)

83 TELMISARTAN USP (1)

84 TORSEMIDE USP (1)

85 TRAMADOL HYDROCHLORIDE (YT3 PROCESS) (1)

86 TRAMADOL HYDROCHLORIDE USP (1)

87 TRIAMTERENE USP (1)

88 TRICLOSAN (1)

89 TRIMETHOPRIM USP (2)

90 VALSARTAN USP (2)

91 VENLAFAXINE HYDROCHLORIDE USP (1)

92 WARFARIN SODIUM CLATHRATE USP (1)

93 WARFARIN SODIUM USP (1)

94 ZOLEDRONIC ACID (1)

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01 IPCA LABORATORIES LTD (94)

02 IPCA LABORATORIES PRIVATE LTD (3)

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01 India (97)

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01 Active (52)

02 Inactive (45)

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01 Complete (39)

02 Blank (58)

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