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

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    01 ACALABRUTINIB DIHYDRATE (1)

    02 ALECTINIB HYDROCHLORIDE (1)

    03 ANASTROZOLE (1)

    04 APIXABAN (1)

    05 BENDAMUSTINE HYDROCHLORIDE (1)

    06 BORTEZOMIB (1)

    07 CABOZANTINIB (S)-MALATE (1)

    08 CARMUSTINE (1)

    09 CHLOROQUINE PHOSPHATE (1)

    10 CIDOFOVIR DIHYDRATE USP (1)

    11 CITALOPRAM HYDROBROMIDE (1)

    12 DILTIAZEM HYDROCHLORIDE, USP (1)

    13 DIMETHYL FUMARATE (1)

    14 ECT-12003 (S-CITALOPRAM OXALATE) (1)

    15 ERIBULIN MESYLATE (1)

    16 ERLOTINIB HYDROCHLORIDE (1)

    17 EVEROLIMUS (1)

    18 FACILITY LOCATED IN ANDRHA PRADESH, INDIA (1)

    19 FLUOXETINE HYDROCHLORIDE (1)

    20 GEFITINIB (1)

    21 GRANISETRON HYDROCHLORIDE (1)

    22 GRANISETRON HYDROCHLORIDE (INJECTABLE GRADE) (1)

    23 IBANDRONATE SODIUM MONOHYDRATE (1)

    24 IBANDRONATE SODIUM MONOHYDRATE (INJECTABLE GRADE) (1)

    25 IBRUTINIB (IBN) (1)

    26 IDELALISIB (1)

    27 IMATINIB MESYLATE (ALPHA 2-FORM) (1)

    28 LANSOPRAZOLE (1)

    29 LANTHANUM CARBONATE DIHYDRATE (1)

    30 LETROZOLE (1)

    31 LETROZOLE (LER) (1)

    32 NAPROXEN SODIUM, USP (1)

    33 NAPROXEN, USP (1)

    34 NILOTINIB HYDROCHLORIDE MONOHYDRATE (1)

    35 OMEPRAZOLE (1)

    36 ONDANSETRON HYDROCHLORIDE (1)

    37 ONDANSETRON HYDROCHLORIDE (INJECTABLE GRADE) (1)

    38 PANTOPRAZOLE SODIUM SESQUIHYDRATE (1)

    39 POMALIDOMIDE (1)

    40 RIZATRIPTAN BENZOATE (1)

    41 RIZATRIPTAN BENZOATE (ROUTE - 2; PRODUCT CODE: RTB) (1)

    42 SALMETEROL XINAFOATE (1)

    43 SORAFENIB TOSYLATE (2)

    44 SUGAMMADEX SODIUM (1)

    45 SUMATRIPTAN (1)

    46 SUMATRIPTAN SUCCINATE (1)

    47 SUMATRIPTAN SUCCINATE (INJECTABLE GRADE) (1)

    48 TAMSULOSIN HYDROCHLORIDE (1)

    49 TERIFLUNOMIDE (1)

    50 THIOTEPA (1)

    51 TIPIRACIL HYDROCHLORIDE (1)

    52 TRIFLURIDINE (1)

    53 TRIHEXYPHENIDYL HYDROCHLORIDE (1)

    54 Tolterodine Tartrate (1)

    55 ZOLEDRONIC ACID (1)

    56 ZOLMITRIPTAN (1)

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    02 NATCO PHARMACEUTICALS PRIVATE LTD (1)

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    ACALABRUTINIB DIHYDRATE

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    NATCO PHARMA LTD
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    36263
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    2021-10-13
    2021-09-20
    2021-09-15
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    ALECTINIB HYDROCHLORIDE

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    NATCO PHARMA LTD
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    36908
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    2022-06-28
    2022-03-15
    2022-03-25
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    ANASTROZOLE

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    NATCO PHARMA LTD
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    19687
    N/A
    2006-08-11
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    APIXABAN

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    NATCO PHARMA LTD
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    30845
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    2017-01-05
    2016-10-27
    2016-09-30
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    BENDAMUSTINE HYDROCHLORIDE

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    NATCO PHARMA LTD
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    26704
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    2013-11-11
    2013-02-22
    2012-12-18
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    BORTEZOMIB

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    NATCO PHARMA LTD
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    26547
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    2016-06-03
    2016-01-21
    2012-12-06
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    CABOZANTINIB (S)-MALATE

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    NATCO PHARMA LTD
    Active
    36509
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    2022-03-23
    2022-02-28
    2022-02-28
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    CARMUSTINE

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    NATCO PHARMA LTD
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    2020-03-03
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    CHLOROQUINE PHOSPHATE

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    NATCO PHARMA LTD
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    33067
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    2019-06-21
    2019-06-14
    2019-02-20
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    CITALOPRAM HYDROBROMIDE

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    NATCO PHARMA LTD
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    17185
    N/A
    2004-02-04
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