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

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    01 ABIRATERONE ACETATE USP (1)

    02 APREMILAST (1)

    03 ATAZANAVIR SULFATE (1)

    04 ATORVASTATIN CALCIUM STABILIZED (1)

    05 AZATHIOPRINE USP (1)

    06 AZATHIOPRINE USP (CODE AZ) (1)

    07 BOSENTAN MONOHYDRATE (1)

    08 BREXPIPRAZOLE (1)

    09 CALCIUM GLUCONATE MONOHYDRATE USP (1)

    10 CARVEDILOL USP (1)

    11 CELECOXIB, USP (1)

    12 CHLORDIAZEPOXIDE HYDROCHLORIDE USP (1)

    13 CHLORPROMAZINE HYDROCHLORIDE USP (1)

    14 CITALOPRAM HYDROBROMIDE, USP (1)

    15 CLIDINIUM BROMIDE USP (1)

    16 CLOBAZAM (1)

    17 CLOPIDOGREL BISULFATE, USP (1)

    18 COLESTIPOL HYDROCHLORIDE USP (1)

    19 DAPAGLIFLOZIN (1)

    20 DARUNAVIR (1)

    21 DEXLANSOPRAZOLE (ROUTE CODE - DR) (1)

    22 DEXLANSOPRAZOLE API (1)

    23 DIBASIC POTASSIUM PHOSPHATE USP-NF (1)

    24 DIMETHYL FUMARATE (1)

    25 DIVALPROEX SODIUM USP (1)

    26 DOXEPIN HYDROCHLORIDE USP (1)

    27 DOXYCYCLINE HYCLATE, USP (1)

    28 DOXYCYCLINE USP (1)

    29 DRONEDARONE HYDROCHLORIDE USP (1)

    30 ELIGLUSTAT HEMITARTRATE (1)

    31 ELTROMBOPAG OLAMINE (1)

    32 ESCITALOPRAM OXALATE, USP (1)

    33 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, USP (1)

    34 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, USP (ROUTE CODE - "ES") (1)

    35 EZETIMIBE USP (1)

    36 FELBAMATE, USP (1)

    37 FESOTERODINE FUMARATE (1)

    38 FLUPHENAZINE HYDROCHLORIDE USP (1)

    39 LEVOMILNACIPRAN HYDROCHLORIDE (1)

    40 LINEZOLID USP (1)

    41 LURASIDONE HYDROCHLORIDE (1)

    42 MACITENTAN (1)

    43 METAXALONE USP (1)

    44 METYROSINE USP (1)

    45 MILNACIPRAN HYDROCHLORIDE, API (1)

    46 MONOBASIC POTASSIUM PHOSPHATE USP-NF (1)

    47 OMEPRAZOLE MAGNESIUM, USP (1)

    48 OMEPRAZOLE, USP (1)

    49 OSELTAMIVIR PHOSPHATE USP (1)

    50 PANTOPRAZOLE SODIUM USP (1)

    51 PIRFENIDONE (1)

    52 POTASSIUM DOBESILATE (1)

    53 PROCHLORPERAZINE EDISYLATE USP (1)

    54 PROCHLORPERAZINE MALEATE USP (1)

    55 QUETIAPINE FUMARATE USP (1)

    56 RABEPRAZOLE SODIUM USP (1)

    57 RALOXIFENE HYDROCHLORIDE, USP (1)

    58 RANOLAZINE (1)

    59 RIFAXIMIN (1)

    60 RITONAVIR, USP (FORM-I) (1)

    61 RIVAROXABAN (1)

    62 SACUBITRIL SODIUM (1)

    63 SALSALATE USP (1)

    64 SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE (1)

    65 SELENIOUS ACID USP (1)

    66 SILDENAFIL CITRATE USP (1)

    67 SOLIFENACIN SUCCINATE (1)

    68 TERIFLUNOMIDE (1)

    69 TICAGRELOR (1)

    70 TRAMADOL HYDROCHLORIDE USP (1)

    71 TRAMADOL HYDROCHLORIDE USP API (PROCESS-2) (1)

    72 VARDENAFIL HYDROCHLORIDE TRIHYDRATE USP (1)

    73 VORTIOXETINE HYDROBROMIDE SOLVATE (1)

    74 WARFARIN SODIUM CLATHRATE USP (1)

    75 ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE, USP (1)

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    01 RAKS PHARMA PVT LTD (75)

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    01 India (75)

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    01 Active (75)

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    01 Complete (65)

    02 Blank (10)

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    • WHO-GMP
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    ABIRATERONE ACETATE USP

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    RAKS PHARMA PVT LTD
    Active
    28905
    Complete
    2015-01-29
    2014-12-12
    2014-12-23
    II
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    APREMILAST

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    RAKS PHARMA PVT LTD
    Active
    31180
    Complete
    2017-02-01
    2016-12-27
    2016-12-29
    II
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    ATAZANAVIR SULFATE

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    RAKS PHARMA PVT LTD
    Active
    29852
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    2016-02-04
    2015-12-03
    2015-12-17
    II
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    ATORVASTATIN CALCIUM STABILIZED

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    RAKS PHARMA PVT LTD
    Active
    26084
    N/A
    2012-05-22
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    AZATHIOPRINE USP

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    RAKS PHARMA PVT LTD
    Active
    23179
    N/A
    2009-10-13
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    AZATHIOPRINE USP (CODE AZ)

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    RAKS PHARMA PVT LTD
    Active
    37207
    Complete
    2022-07-29
    2022-06-24
    2022-06-30
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    BOSENTAN MONOHYDRATE

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    RAKS PHARMA PVT LTD
    Active
    32757
    Complete
    2018-05-22
    2018-04-27
    2018-04-30
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    BREXPIPRAZOLE

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    RAKS PHARMA PVT LTD
    Active
    33451
    Complete
    2019-02-25
    2018-12-20
    2018-12-26
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    CALCIUM GLUCONATE MONOHYDRATE USP

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    RAKS PHARMA PVT LTD
    Active
    36938
    Complete
    2022-05-25
    2022-03-24
    2022-04-12
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    CARVEDILOL USP

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    RAKS PHARMA PVT LTD
    Active
    23743
    Complete
    2014-10-02
    2013-10-24
    2010-04-13
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