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

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    SUN PHARMACEUTICAL INDUSTRIES LIMITED

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    Sun Pharmaceutical Industries Limited
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    India
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    Sun House, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063
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    +91-22-4324 4324, +91 22 6696 9696
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    7-AMINO-3-DESACETOXY CEPHALOSPORANI...

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    RANBAXY LABORATORIES ...
    Inactive
    10639
    N/A
    1993-12-28
    II
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    ABIRATERONE ACETATE

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    SUN PHARMACEUTICAL IN...
    Active
    28959
    Complete
    2015-04-20
    2015-01-02
    2015-02-11
    II
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    ACITRETIN USP

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    SUN PHARMACEUTICAL IN...
    Active
    28896
    Complete
    2015-02-07
    2014-12-11
    2014-12-22
    II
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    ACITRETIN USP

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    SUN PHARMACEUTICAL IN...
    Inactive
    16580
    N/A
    2003-05-12
    II
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    ACYCLOVIR DRUG SUBSTANCE

    PDF Supplier PDF
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    RANBAXY INC
    Inactive
    12159
    N/A
    1996-10-08
    II
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    ADAPALENE USP, MICRONIZED

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    NA Not Available For Sales
    TARO PHARMACEUTICAL I...
    Active
    21208
    Complete
    2014-07-07
    2014-03-11
    2008-01-02
    II
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    ADEFOVIR DIPIVOXIL

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    SUN PHARMACEUTICAL IN...
    Inactive
    23993
    N/A
    2010-07-26
    II
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    AFATINIB DIMALEATE

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    SUN PHARMACEUTICAL IN...
    Active
    31515
    Complete
    2017-06-29
    2017-04-28
    2017-05-31
    II
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    ALECTINIB HYDROCHLORIDE

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    SUN PHARMACEUTICAL IN...
    Active
    34128
    N/A
    2019-12-16
    II
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    ALENDRONATE SODIUM USP

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    SUN PHARMACEUTICAL IN...
    Active
    20786
    N/A
    2007-08-14
    II
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    ALUMINUM CHLORHYDROXIDE COMPLEX ACH...

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    CHATTEM DRUG & CHEMIC...
    Inactive
    1035
    N/A
    1967-02-16
    II
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    AMBRISENTAN

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    SUN PHARMACEUTICAL IN...
    Active
    36105
    Complete
    2021-09-02
    2021-07-22
    2021-07-22
    II
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    AMCINONIDE USP MICRONIZED

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    NA Not Available For Sales
    TARO PHARMACEUTICAL I...
    Active
    14374
    N/A
    1999-08-30
    II
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    AMIFOSTINE USP

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    SUN PHARMACEUTICAL IN...
    Active
    17186
    N/A
    2004-02-26
    II
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    AMINOACETIC ACID (GLYCINE)

    PDF Supplier PDF
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    CHATTEM CHEMICALS INC
    Active
    1271
    N/A
    1968-12-13
    II
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    AMIODARONE HCL USP

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    NA Not Available For Sales
    TARO PHARMACEUTICAL I...
    Active
    15794
    N/A
    2001-12-27
    II
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    AMITRIPTYLINE HYDROCHLORIDE USP

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    SUN PHARMACEUTICAL IN...
    Active
    19589
    N/A
    2006-07-12
    II
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    AMMONIUM LACTATE

    PDF Supplier PDF
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    CHATTEM CHEMICALS INC
    Active
    13843
    Complete
    2023-08-15
    2023-07-12
    1998-11-12
    II
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    AMOXICILLIN USP, TRIHYDRATE, (NON-S...

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    SUN PHARMACEUTICAL IN...
    Inactive
    12895
    N/A
    1998-03-11
    II
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    AMPHETAMINE SULFATE USP

    PDF Supplier PDF
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    CHATTEM CHEMICALS INC
    Active
    33233
    N/A
    2018-11-16
    II
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    AMPICILLIN TRIHYDRATE

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    RANBAXY LABORATORIES ...
    Inactive
    13712
    N/A
    1998-09-01
    II
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    ANASTROZOLE USP

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    SUN PHARMACEUTICAL IN...
    Active
    21901
    Complete
    2018-05-11
    2018-04-03
    2008-09-27
    II
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    APIXABAN

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    SUN PHARMACEUTICAL IN...
    Active
    30788
    Complete
    2016-12-22
    2016-09-06
    2016-09-23
    II
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    APREMILAST

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    SUN PHARMACEUTICAL IN...
    Active
    32473
    Complete
    2018-07-25
    2018-02-09
    2018-07-16
    II
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    ARIPIPRAZOLE

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    SUN PHARMACEUTICAL IN...
    Inactive
    19949
    N/A
    2006-11-06
    II
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    ARIPIPRAZOLE USP

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    SUN PHARMACEUTICAL IN...
    Active
    36774
    Complete
    2024-01-16
    2023-12-13
    2022-02-14
    II
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    ASENAPINE MALEATE

    PDF Supplier PDF
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    SUN PHARMACEUTICAL IN...
    Active
    27185
    Complete
    2013-10-01
    2013-06-25
    2013-07-17
    II
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    ATAZANAVIR SULFATE

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    SUN PHARMACEUTICAL IN...
    Active
    31229
    Complete
    2017-03-23
    2017-01-05
    2017-03-07
    II
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    ATAZANAVIR SULFATE

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    SUN PHARMACEUTICAL IN...
    Inactive
    24970
    N/A
    2011-05-24
    II
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    ATOMOXETINE HYDROCHLORIDE USP

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    SUN PHARMACEUTICAL IN...
    Active
    20552
    N/A
    2007-05-21
    II
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    ATORVASTATIN CALCIUM (AMORPHOUS)

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    SUN PHARMACEUTICAL IN...
    Inactive
    25657
    N/A
    2012-02-20
    II
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    ATORVASTATIN CALCIUM TRIHYDRATE USP

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    SUN PHARMACEUTICAL IN...
    Active
    24139
    Complete
    2020-06-22
    2020-06-16
    2010-09-07
    II
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    ATORVASTATIN CALCIUM(AMORPHOUS)

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    RANBAXY LABORATORIES ...
    Inactive
    16098
    N/A
    2002-08-19
    II
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    ATORVASTATIN MAGNESIUM

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    RANBAXY LABORATORIES ...
    Inactive
    17484
    N/A
    2004-06-21
    II
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    ATOVAQUONE USP, MICRONIZED

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    NA Not Available For Sales
    TARO PHARMACEUTICAL I...
    Active
    26906
    Complete
    2014-09-15
    2013-03-22
    2013-03-21
    II
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    • FDA
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    AZACITIDINE

    PDF Supplier PDF
    URL Supplier Web Content
    SUN PHARMACEUTICAL IN...
    Active
    29864
    Complete
    2017-02-15
    2015-10-07
    2016-09-30
    II
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    AZELAIC ACID, MICRONIZED

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    NA Not Available For Sales
    TARO PHARMACEUTICAL I...
    Active
    29484
    Complete
    2016-02-05
    2015-11-30
    2015-12-01
    II
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    AZITHROMYCIN MONOHYDRATE USP

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    NA Not Available For Sales
    TARO PHARMACEUTICAL I...
    Active
    28294
    Complete
    2015-06-29
    2015-03-02
    2015-03-02
    II
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    BENAZEPRIL HYDROCHLORIDE USP

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    SUN PHARMACEUTICAL IN...
    Inactive
    15776
    N/A
    2001-12-21
    II
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    BENDAMUSTINE HYDROCHLORIDE

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    SUN PHARMACEUTICAL IN...
    Active
    26723
    Complete
    2013-10-10
    2012-12-28
    2013-01-04
    II
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    BENZPHETAMINE HYDROCHLORIDE

    PDF Supplier PDF
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    CHATTEM CHEMICALS INC
    Active
    18893
    N/A
    2005-10-21
    II
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    BETAMETHASONE 17-VALERATE, USP MICR...

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    NA Not Available For Sales
    TARO PHARMACEUTICAL I...
    Active
    15004
    Complete
    2015-03-16
    2015-03-06
    2000-08-18
    II
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    BETAMETHASONE DIPROPIONATE USP, MIC...

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    NA Not Available For Sales
    TARO PHARMACEUTICAL I...
    Active
    14651
    Complete
    2017-04-24
    2017-04-06
    1999-12-30
    II
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    BICALUTAMIDE USP

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    SUN PHARMACEUTICAL IN...
    Active
    20263
    N/A
    2007-02-10
    II
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    BIVALIRUDIN

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    SUN PHARMACEUTICAL IN...
    Active
    24423
    N/A
    2011-01-15
    II
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    BORTEZOMIB

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    SUN PHARMACEUTICAL IN...
    Active
    28957
    Complete
    2015-04-03
    2015-01-02
    2015-01-20
    II
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    BOSENTAN MONOHYDRATE

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    SUN PHARMACEUTICAL IN...
    Inactive
    23817
    N/A
    2010-12-23
    II
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    BOSENTAN MONOHYDRATE

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    SUN PHARMACEUTICAL IN...
    Active
    32672
    Complete
    2019-11-25
    2019-09-05
    2019-09-26
    II
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    BOSUTINIB

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    SUN PHARMACEUTICAL IN...
    Active
    36121
    Complete
    2021-10-13
    2021-08-11
    2021-08-19
    II
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    BUDESONIDE USP

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    SUN PHARMACEUTICAL IN...
    Active
    26445
    Complete
    2014-02-03
    2013-09-27
    2013-09-30
    II
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