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

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01 ACITRETIN (1)

02 ACYCLOVIR SODIUM (1)

03 ALBENDAZOLE (1)

04 APREPITANT (1)

05 ARTEMETHER (1)

06 ARTESUNATE (1)

07 ATRACURIUM BESYLATE USP (1)

08 BRIVARACETAM (1)

09 BUMETANIDE USP (1)

10 BUSPIRONE HYDROCHLORIDE USP (1)

11 CARISOPRODOL USP (1)

12 CELECOXIB USP (1)

13 CETIRIZINE HYDROCHLORIDE DIHYDROCHLORIDE USP (1)

14 CHLORPROMAZINE HYDROCHLORIDE USP (1)

15 CHLORTHALIDONE USP (1)

16 CINACALCET HYDROCHLORIDE (1)

17 CLOMIPRAMINE HCL USP (1)

18 COLCHICINE (1)

19 COLESEVELAM HYDROCHLORIDE (1)

20 COLESTIPOL HYDROCHLORIDE USP (1)

21 CYCLOSERINE USP (1)

22 DABIGATRAN ETEXILATE MESYLATE (1)

23 DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE, USP (1)

24 DEXTROMETHORPHAN POLISTIREX (1)

25 DIPYRIDAMOLE USP (1)

26 DISULFIRAM USP (1)

27 EDARAVONE (1)

28 EFINACONAZOLE (1)

29 ERTAPENEM SODIUM (1)

30 ERYTHROMYCIN ETHYLSUCCINATE USP (1)

31 ETHACRYNIC ACID USP (1)

32 ETOMIDATE (1)

33 FELBAMATE (1)

34 FLECAINIDE ACETATE USP (1)

35 FLUCYTOSINE USP (1)

36 GABAPENTIN USP (1)

37 HYDRALAZINE HYDROCHLORIDE USP (1)

38 IBUPROFEN ARGININE (1)

39 IBUPROFEN LYSINE (1)

40 IBUPROFEN SODIUM DIHYDRATE (2)

41 IBUPROFEN USP (1)

42 IMIQUIMOD (1)

43 INDOMETHACIN SODIUM (1)

44 ISRADIPINE, USP (1)

45 KETOPROFEN USP (1)

46 LABETALOL HYDROCHLORIDE (1)

47 LANTHANUM CARBONATE OCTAHYDRATE (1)

48 LANTHANUM CARBONATE TETRAHYDRATE (1)

49 LEVETIRACETAM USP (1)

50 LORATADINE USP (1)

51 LUMEFANTRINE (1)

52 LURASIDONE HYDROCHLORIDE (1)

53 MEBENDAZOLE USP (1)

54 MEFENAMIC ACID USP ( PRODUCT CODE : 05P) (1)

55 MEFENAMIC ACID, USP (1)

56 MEPROBAMATE USP (1)

57 MESALAMINE USP (1)

58 MESNA (1)

59 METHOHEXITAL USP (1)

60 METHOXSALEN USP (1)

61 MIDAZOLAM (1)

62 MILNACIPRAN HYDROCHLORIDE (1)

63 MIRABEGRON (1)

64 MYCOPHENOLATE MOFETIL USP (1)

65 MYCOPHENOLATE SODIUM USP (1)

66 NAPROXEN SODIUM USP (2)

67 NAPROXEN USP (1)

68 NAPROXEN, USP (1)

69 NIZATIDINE USP (1)

70 OBETICHOLIC ACID (1)

71 OLANZAPINE USP (1)

72 OSELTAMIVIR PHOSPHATE (1)

73 PANTOPRAZOLE SODIUM, USP (1)

74 PATIROMER SORBITEX CALCIUM (1)

75 PITAVASTATIN CALCIUM (1)

76 POSACONAZOLE FORM-1 (1)

77 PRAZIQUANTEL (1)

78 PREGABALIN USP (1)

79 QUINAPRIL HYDROCHLORIDE (1)

80 RANITIDINE (1)

81 RANITIDINE HYDROCHLORIDE (1)

82 RANITIDINE HYDROCHLORIDE, USP (FORM II) (1)

83 RIFAXIMIN (1)

84 ROTIGOTINE USP (1)

85 S-IBUPROFEN (1)

86 SAFINAMIDE MESYLATE (1)

87 SAPROPTERIN DIHYDROCHLORIDE (1)

88 SEVELAMER CARBONATE (1)

89 SEVELAMER HYDROCHLORIDE (1)

90 SODIUM ZIRCONIUM CYCLOSILICATE (1)

91 SUCCINYLCHOLINE CHLORIDE (1)

92 SUCROFERRIC OXYHYDROXIDE (1)

93 SUGAMMADEX SODIUM (1)

94 SULPHAZINE (1)

95 TENOFOVIR DISOPROXIL FUMARATE (1)

96 TIOCONAZOLE (1)

97 URSODEOXYCHOLIC ACID (URSODIOL) (1)

98 VENLAFAXINE HYDROCHLORIDE (1)

99 ZIDOVUDINE (1)

100 ZILEUTON USP (1)

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01 SOLARA ACTIVE PHARMA SCIENCES LTD (102)

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01 India (102)

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01 Active (95)

02 Inactive (7)

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01 Complete (45)

02 Blank (57)

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SOLARA ACTIVE PHARMA ...
Active
22358
N/A
2008-12-29
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SOLARA ACTIVE PHARMA ...
Active
24289
N/A
2010-10-15
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SOLARA ACTIVE PHARMA ...
Active
28558
Complete
2015-10-22
2015-09-08
2014-08-13
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SOLARA ACTIVE PHARMA ...
Active
29215
N/A
2015-03-27
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SOLARA ACTIVE PHARMA ...
Active
22995
N/A
2009-07-28
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SOLARA ACTIVE PHARMA ...
Active
24028
N/A
2010-08-05
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SOLARA ACTIVE PHARMA ...
Active
38238
N/A
2023-03-31
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SOLARA ACTIVE PHARMA ...
Active
36304
N/A
2021-09-30
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SOLARA ACTIVE PHARMA ...
Active
33261
Complete
2019-04-12
2019-02-11
2018-10-27
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