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

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01 7-AMINO-3-CHLORO-3-CEPHEM-4-CARBONXYLIC ACID-DRUG SUBSTANCE INTERMEDIATE (1)

02 7-AMINO-3-CHLORO-3-CEPHEM-4-CARBOXYLIC ACID (1)

03 7-AMINO-3-DESACETOXY CEPHALOSPORANIC ACID DRUG SUBSTANCE INTERMEDIATE (1)

04 7-AMINO-3-VINYL-3-CEPHEM-4-CARBOXYLIC ACID [7-AVCA] DRUG SUBSTANCE INTERMEDIATE (1)

05 7-AMINO-3-[(Z)-PROPEN-1-YL]-3-CEPHEM-4-CARBOXYLIC ACID (7-APCA) (1)

06 ACITRETIN USP (1)

07 ACYCLOVIR DRUG SUBSTANCE (1)

08 ADEFOVIR DIPIVOXIL (1)

09 AMMONIUM SALT OF MEVINOLINIC ACID (1)

10 AMOXICILLIN USP, TRIHYDRATE, (NON-STERILE BULK) (1)

11 AMPICILLIN TRIHYDRATE (1)

12 ATAZANAVIR SULFATE (1)

13 ATORVASTATIN CALCIUM TRIHYDRATE USP (1)

14 ATORVASTATIN CALCIUM(AMORPHOUS) (1)

15 ATORVASTATIN MAGNESIUM (1)

16 BENAZEPRIL HYDROCHLORIDE USP (1)

17 BICYCLOKETONE DRUG SUBSTANCE INTERMEDIATE (1)

18 BOSENTAN MONOHYDRATE (1)

19 CANDESARTAN CILEXETIL (NON STERILE BULK) DRUG SUBSTANCE (1)

20 CEFACLOR (1)

21 CEFADROXIL (1)

22 CEFADROXIL USP, HEMIHYDRATE, (NON-STERILE BULK) (1)

23 CEFDINIR (1)

24 CEFDITOREN PIVOXIL DRUG SUBSTANCE (1)

25 CEFDITOREN SODIUM INTERMEDIATE DRUG SUBSTANCE (1)

26 CEFPODOXIME ACID (1)

27 CEFPODOXIME PROXETIL USP (1)

28 CEFPROZIL USP (NON-STERILE BULK) (1)

29 CEFUROXIME ACID (1)

30 CEFUROXIME AXETIL (1)

31 CEFUROXIME AXETIL USP (1)

32 CEFUROXIME AXETIL USP (CRYSTALLINE) (1)

33 CEPHALEXIN USP (1)

34 CILASTATIN ACID (1)

35 CILASTATIN SODIUM USP (STERILE) (1)

36 CILOSTAZOL DRUG SUBSTANCE (1)

37 CIPROFLOXACIN HYDROCHLORIDE USP (1)

38 CITALOPRAM HYDROBROMIDE (1)

39 CLARITHROMYCIN USP (1)

40 CLOFARABINE (1)

41 CLORAZEPATE DIPOTASSIUM USP (1)

42 COMPACTIN DRUG SUBSTANCE INTERMEDIATE (1)

43 DESLORATADINE DRUG SUBSTANCE (1)

44 DONEPEZIL HYDROCHLORIDE (MONOHYDRATE) USP (1)

45 DOXYCYCLINE HYCLATE USP (1)

46 DOXYCYCLINE USP (1)

47 DULOXETINE HYDROCHLORIDE DRUG SUBSTANCE (1)

48 EFAVIRENZ (1)

49 EMTRICITABINE DRUG SUBSTANCE (1)

50 ENALAPRIL MALEATE USP (1)

51 ENTACAPONE (1)

52 ESOMEPRAZOLE MAGNESIUM (AMORPHOUS, NON-STERILE BULK DRUG SUBSTANCE) (1)

53 ETODOLAC DRUG SUBSTANCE (1)

54 EXENATIDE (1)

55 FEBUXOSTAT (1)

56 FEXOFENADINE HYDROCHLORIDE USP (1)

57 FLUOXETINE HYDROCHLORIDE (1)

58 FOSAMPRENAVIR CALCIUM (1)

59 FOSINOPRIL SODIUM USP (NON-STERILE BULK) (1)

60 GABAPENTIN USP (NON-STERILE BULK) (1)

61 GALANTAMINE HYDROBROMIDE USP (1)

62 GANCICLOVIR (1)

63 GANCICLOVIR (INTERMEDIATE DRUG SUBSTANCE) (1)

64 IMIPENEM TECHNICAL DRUG SUBSTANCE INTERMEDIATE (1)

65 IMIPENEM USP (STERILE) (1)

66 IRBESARTAN USP (1)

67 ISOTRETINOIN USP (NON-STERILE BULK) (1)

68 LAMIVUDINE (DRUG SUBSTANCE INTERMEDIATE) (1)

69 LAMIVUDINE (FORM I) (1)

70 LAMIVUDINE USP (1)

71 LANSOPRAZOLE USP (1)

72 LEVETIRACETAM (1)

73 LEVOFLOXACIN USP (1)

74 LISINOPRIL USP (NON-STERILE BULK) (1)

75 LORATADINE USP (1)

76 LORAZEPAM USP (1)

77 LOVASTATIN USP (1)

78 LOVASTATION USP (1)

79 Lopinavir Drug Substance (1)

80 MEMANTINE HYDROCHLORIDE (1)

81 MEROPENEM TECHNICAL (1)

82 MESALAMINE USP (1)

83 MIDAZOLAM (NON-STERILE BULK) USP (1)

84 MILNACIPRAN HYDROCHLORIDE (1)

85 Meropenem Technical (1)

86 NEVIRAPINE USP (ANHYDROUS) (NON-STERILE BULK) DRUG SUBSTANCE (1)

87 OFLOXACIN USP (1)

88 OLANZAPINE DRUG SUBSTANCE (1)

89 OLMESARTAN MEDOXOMIL (1)

90 OMEPRAZOLE MAGNESIUM USP (1)

91 ORLISTAT (NON-STERILE BULK) (1)

92 PALONOSETRON HYDROCHLORIDE (1)

93 PANTOPRAZOLE SODIUM USP (1)

94 PIOGLITAZONE HYDROCHLORIDE USP (1)

95 PRAVASTATIN SODIUM (1)

96 QUETIAPINE FUMARATE (NON-STERILE BULK) (1)

97 QUINAPRIL HYDROCHLORIDE USP (1)

98 RAMIPRIL (1)

99 RANITIDINE HYDROCHLORIDE (1)

100 RANITIDINE HYDROCHLORIDE USP (1)

101 REPAGLINIDE USP (1)

102 RITONAVIR (1)

103 Rabeprazole Sodium (Non-Sterile Bulk Drug Substance) (1)

104 S-(+)-FLURBIPROFEN (1)

105 SERTRALINE HYDROCHLORIDE DRUG SUBTANCE (1)

106 SIMVASTATIN USP (1)

107 SODIUM BICARBONATE USP (STERILE) (1)

108 SODIUM CARBONATE ANHYDROUS USNF (STERILE) (1)

109 SOLIFENACIN SUCCINATE (1)

110 STAVUDINE USP (1)

111 T-3811A 05 (1)

112 TADALAFIL (NON STERILE BULK) DRUG SUBSTANCE (1)

113 TADALAFIL USP (1)

114 TAMSULOSIN HYDROCHLORIDE USP (1)

115 TELBIVUDINE (1)

116 TELMISARTAN USP (NON-STERILE BULK) (1)

117 TENOFOVIR DISOPROXIL FUMARATE DRUG SUBSTANCE (1)

118 TERFENADINE (1)

119 TIAGABINE HYDROCHLORIDE USP (1)

120 TOLTERODINE TARTRATE (1)

121 TRETINOIN USP (NON STERILE BULK) (1)

122 TROSPIUM CHLORIDE (NON-STERILE BULK) (1)

123 VALACYCLOVIR HYDROCHLORIDE USP (HYDROUS) (1)

124 VALGANCICLOVIR HYDROCHLORIDE (NON-STERILE BULK) (1)

125 VALGANCICLOVIR HYDROCHLORIDE, USP (PROCESS 2; SITE TOANSA) (1)

126 VALSARTAN USP (1)

127 VENLAFAXINE HYDROCHLORIDE (1)

128 ZIDOVUDINE USP DRUG SUBSTANCE (1)

129 ZIPRASIDONE HYDROCHLORIDE (1)

130 ZOLPIDEM TARTRATE DRUG SUBSTANCE (1)

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01 RANBAXY INC (1)

02 RANBAXY LABORATORIES INC (1)

03 RANBAXY LABORATORIES LTD (60)

04 RANBAXY PHARMACEUTICALS INC (1)

05 SUN PHARMACEUTICAL INDUSTRIES LTD (67)

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01 India (130)

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01 Active (8)

02 Inactive (122)

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01 Complete (5)

02 Blank (125)

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RANBAXY LABORATORIES ...
Inactive
10639
N/A
1993-12-28
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SUN PHARMACEUTICAL IN...
Inactive
16580
N/A
2003-05-12
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RANBAXY INC
Inactive
12159
N/A
1996-10-08
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SUN PHARMACEUTICAL IN...
Inactive
23993
N/A
2010-07-26
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SUN PHARMACEUTICAL IN...
Inactive
12895
N/A
1998-03-11
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RANBAXY LABORATORIES ...
Inactive
13712
N/A
1998-09-01
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SUN PHARMACEUTICAL IN...
Inactive
24970
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2011-05-24
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SUN PHARMACEUTICAL IN...
Active
24139
Complete
2020-06-22
2020-06-16
2010-09-07
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RANBAXY LABORATORIES ...
Inactive
16098
N/A
2002-08-19
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RANBAXY LABORATORIES ...
Inactive
17484
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2004-06-21
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