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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Axplora

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    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

    Key Products KEY PRODUCTS

    • Acetylcysteine

    • Beclomethasone Dipropionate

    • Carbocisteine

    • Diflucortolone Valerate

    • Icosapent Ethyl

    • Medroxyprogesterone Acetate

    • Megestrol Acetate

    • Mesalazine

    • Nitroglycerin

    • Omega-3-Acid Ethyl Esters 90

    • Propafenone Hydrochloride

    • Triamcinolone

    • Triamcinolone Acetonide

    • Triamcinolone Diacetate

    • Triamcinolone Hexacetonide

    • Ursodeoxycholic Acid

    INTERMEDIATES

    SERVICES

    Key Products KEY SERVICES

    • Complex API Development Services

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    Acetylcysteine

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    USDMF

    Found USDMF

    5836
    Active
    N-ACETYL-L-CYSTEINE
    1985-03-29
    CEP/COS

    Found CEP/COS

    R2-CEP 1995-028 - Rev 04
    Valid
    Acetylcysteine
    2020-12-15
    Japanese DMF

    Found JDMF

    219MF10377
    Acetylcysteine at ROSENHEIMER STR. ...
    2007-12-19
    Written Confirmation

    Close WC

    Application Number
    5836
    R2-CEP 1995-028 - Rev 04
    219MF10377
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    N-ACETYL-L-CYSTEINE
    Acetylcysteine
    Acetylcysteine at ROSENHEIMER STR. ...
    Issue/Submission Date
    1985-03-29
    2020-12-15
    2007-12-19
    Axplora CB

    Iran Expo

    Not Confirmed

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    Betamethasone Valerate

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    USDMF

    Found USDMF

    12749
    Active
    BETAMETHASONE VALERATE
    1997-11-18
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-078 - Rev 03
    Valid
    Betamethasone valerate, Micronised
    2021-03-22
    Japanese DMF

    Found JDMF

    304MF10098
    Betamethasone Valerate at Via Pavia...
    2022-07-06
    Written Confirmation

    Close WC

    Application Number
    12749
    R1-CEP 2002-078 - Rev 03
    304MF10098
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BETAMETHASONE VALERATE
    Betamethasone valerate, Micronised
    Betamethasone Valerate at Via Pavia...
    Issue/Submission Date
    1997-11-18
    2021-03-22
    2022-07-06
    Axplora CB

    Iran Expo

    Not Confirmed

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    Carbocisteine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1998-038 - Rev 05
    Valid
    Carbocisteine
    2017-05-19
    Japanese DMF

    Found JDMF

    225MF10208
    L- carbocisteine at Plot No. B5&B6,...
    2013-11-14
    Written Confirmation

    Found WC

    Indian CDSCO WC-0102
    Valid
    Carbocisteine BP/Ph.Eur
    2022-06-24
    Application Number
    R1-CEP 1998-038 - Rev 05
    225MF10208
    Indian CDSCO WC-0102
    Status
    Valid
     
    Valid
    2025-07-02
    Filing Details
    Carbocisteine
    L- carbocisteine at Plot No. B5&B6,...
    Carbocisteine BP/Ph.Eur
    Issue/Submission Date
    2017-05-19
    2013-11-14
    2022-06-24
    Axplora CB

    Iran Expo

    Not Confirmed

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    Clobetasol Propionate

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    USDMF

    Found USDMF

    8336
    Active
    CLOBETASOL PROPIONATE
    1989-12-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-135 - Rev 03
    Valid
    Clobetasol propionate, Micronised, ...
    2021-12-16
    Japanese DMF

    Found JDMF

    222MF10130
    Produced only clobetasol propionate...
    2010-04-12
    Written Confirmation

    Close WC

    Application Number
    8336
    R1-CEP 2011-135 - Rev 03
    222MF10130
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CLOBETASOL PROPIONATE
    Clobetasol propionate, Micronised, ...
    Produced only clobetasol propionate...
    Issue/Submission Date
    1989-12-09
    2021-12-16
    2010-04-12
    Axplora CB

    Iran Expo

    Not Confirmed

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    Fluocinolone Acetonide

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    USDMF

    Found USDMF

    17395
    Active
    FLUOCINOLONE ACETONIDE
    2004-05-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-103 - Rev 02
    Valid
    Fluocinolone acetonide, Micronised,...
    2023-02-16
    Japanese DMF

    Found JDMF

    218MF10445
    Fluocinolone Acetonide at Via Pavia...
    2006-04-27
    Written Confirmation

    Close WC

    Application Number
    17395
    R1-CEP 2004-103 - Rev 02
    218MF10445
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FLUOCINOLONE ACETONIDE
    Fluocinolone acetonide, Micronised,...
    Fluocinolone Acetonide at Via Pavia...
    Issue/Submission Date
    2004-05-19
    2023-02-16
    2006-04-27
    Axplora CB

    Iran Expo

    Not Confirmed

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    Mesalazine

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    USDMF

    Found USDMF

    8070
    Active
    5-AMINOSALICYLIC ACID (MESALAZINE/M...
    1989-05-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10036
    Mesalazine at ROSENHEIMER STR. 43 D...
    2007-02-13
    Written Confirmation

    Found WC

    Indian CDSCO WC-0019
    Valid
    Mesalazine Ph. Eur & Mesalamine USP
    2022-03-18
    Application Number
    8070
    219MF10036
    Indian CDSCO WC-0019
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-05-28
    Filing Details
    5-AMINOSALICYLIC ACID (MESALAZINE/M...
    Mesalazine at ROSENHEIMER STR. 43 D...
    Mesalazine Ph. Eur & Mesalamine USP
    Issue/Submission Date
    1989-05-09
    2007-02-13
    2022-03-18
    Axplora CB

    Iran Expo

    Not Confirmed

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    Propafenone Hydrochloride

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    USDMF

    Found USDMF

    10641
    Active
    PROPAFENONE HYDROCHLORIDE
    1993-12-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-236 - Rev 03
    Valid
    Propafenone hydrochloride
    2018-06-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0102
    Valid
    Propafenone Hydrochloride Ph.Eur/US...
    2022-06-24
    Application Number
    10641
    R1-CEP 2005-236 - Rev 03
    Indian CDSCO WC-0102
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    PROPAFENONE HYDROCHLORIDE
    Propafenone hydrochloride
    Propafenone Hydrochloride Ph.Eur/US...
    Issue/Submission Date
    1993-12-16
    2018-06-08
    2022-06-24
    Axplora CB

    Iran Expo

    Not Confirmed

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    Triamcinolone Acetonide

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    USDMF

    Found USDMF

    14693
    Active
    TRIAMCINOLONE ACETONIDE
    2000-02-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-075 - Rev 07
    Valid
    Triamcinolone acetonide, Micronised...
    2021-02-25
    Japanese DMF

    Found JDMF

    305MF10085
    Triamcinolone Acetonide at Via Pavi...
    2023-07-19
    Written Confirmation

    Close WC

    Application Number
    14693
    R1-CEP 2000-075 - Rev 07
    305MF10085
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TRIAMCINOLONE ACETONIDE
    Triamcinolone acetonide, Micronised...
    Triamcinolone Acetonide at Via Pavi...
    Issue/Submission Date
    2000-02-01
    2021-02-25
    2023-07-19
    Axplora CB

    Iran Expo

    Not Confirmed

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    Triamcinolone Acetonide

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    USDMF

    Found USDMF

    21591
    Active
    TRIAMCINOLONE ACETONIDE MICRONIZED ...
    2008-05-01
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-315 - Rev 00
    Valid
    Triamcinolone acetonide, Process 2,...
    2021-12-21
    Japanese DMF

    Found JDMF

    223MF10049
    Triamcinolone acetonide sterile at ...
    2011-04-12
    Written Confirmation

    Close WC

    Application Number
    21591
    R0-CEP 2021-315 - Rev 00
    223MF10049
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TRIAMCINOLONE ACETONIDE MICRONIZED ...
    Triamcinolone acetonide, Process 2,...
    Triamcinolone acetonide sterile at ...
    Issue/Submission Date
    2008-05-01
    2021-12-21
    2011-04-12
    Axplora CB

    Iran Expo

    Not Confirmed

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    Balsalazide Disodium

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    USDMF

    Found USDMF

    16425
    Active
    BALSALAZIDE DISODIUM
    2003-02-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0102
    Valid
    Balsalazide Disodium USP
    2022-06-24
    Application Number
    16425
    Indian CDSCO WC-0102
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    BALSALAZIDE DISODIUM
    Balsalazide Disodium USP
    Issue/Submission Date
    2003-02-17
    2022-06-24
    Axplora CB

    Iran Expo

    Not Confirmed

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    Beclomethasone Dipropionate

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    USDMF

    Found USDMF

    12813
    Active
    BECLOMETHASONE DIPROPIONATE
    1998-01-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-315 - Rev 02
    Valid
    Beclometasone dipropionate, Microni...
    2017-06-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12813
    R1-CEP 2001-315 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BECLOMETHASONE DIPROPIONATE
    Beclometasone dipropionate, Microni...
    Issue/Submission Date
    1998-01-05
    2017-06-28
    Axplora CB

    Iran Expo

    Not Confirmed

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    Betamethasone Dipropionate

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    USDMF

    Found USDMF

    23118
    Active
    BETAMETHASONE DIPROPIONATE MICRONIZ...
    2009-09-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-232 - Rev 03
    Valid
    Betamethasone dipropionate, Microni...
    2023-02-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23118
    R1-CEP 2003-232 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BETAMETHASONE DIPROPIONATE MICRONIZ...
    Betamethasone dipropionate, Microni...
    Issue/Submission Date
    2009-09-16
    2023-02-08
    Axplora CB

    Iran Expo

    Not Confirmed

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    Budesonide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    18910
    Active
    BUDESONIDE
    2005-10-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-051 - Rev 02
    Valid
    Budesonide, micronised
    2010-05-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18910
    R1-CEP 2000-051 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BUDESONIDE
    Budesonide, micronised
    Issue/Submission Date
    2005-10-26
    2010-05-04
    Axplora CB

    Iran Expo

    Not Confirmed

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    Budesonide

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    USDMF

    Found USDMF

    25615
    Active
    BUDESONIDE MICRONIZED STERILE
    2011-12-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-174 - Rev 01
    Valid
    Budesonide, Micronised, grades 21, ...
    2017-07-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25615
    R1-CEP 2005-174 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    BUDESONIDE MICRONIZED STERILE
    Budesonide, Micronised, grades 21, ...
    Issue/Submission Date
    2011-12-20
    2017-07-25
    Axplora CB

    Iran Expo

    Not Confirmed

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    Busulfan

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25933
    Active
    BUSULFAN
    2012-03-27
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-265 - Rev 00
    Valid
    Busulfan
    2020-03-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25933
    R0-CEP 2018-265 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BUSULFAN
    Busulfan
    Issue/Submission Date
    2012-03-27
    2020-03-24
    Axplora CB

    Iran Expo

    Not Confirmed

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    Celecoxib

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26356
    Active
    CELECOXIB USP
    2012-08-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0019
    Valid
    Celecoxib (USP/Ph. Eur.)
    2022-03-18
    Application Number
    26356
    Indian CDSCO WC-0019
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-05-28
    Filing Details
    CELECOXIB USP
    Celecoxib (USP/Ph. Eur.)
    Issue/Submission Date
    2012-08-20
    2022-03-18
    Axplora CB

    Iran Expo

    Not Confirmed

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    Cyproterone Acetate

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    USDMF

    Found USDMF

    18043
    Active
    CYPROTERONE ACETATE
    2005-02-01
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-270 - Rev 00
    Valid
    Cyproterone acetate, Micronised
    2020-08-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18043
    R0-CEP 2018-270 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CYPROTERONE ACETATE
    Cyproterone acetate, Micronised
    Issue/Submission Date
    2005-02-01
    2020-08-03
    Axplora CB

    Iran Expo

    Not Confirmed

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    Cystine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2002-037 - Rev 02
    Valid
    Cystine
    2017-01-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0102
    Valid
    Cystine BP/Ph.Eur
    2022-06-24
    Application Number
    R1-CEP 2002-037 - Rev 02
    Indian CDSCO WC-0102
    Status
    Valid
     
    Valid
    2025-07-02
    Filing Details
    Cystine
    Cystine BP/Ph.Eur
    Issue/Submission Date
    2017-01-23
    2022-06-24
    Axplora CB

    Iran Expo

    Not Confirmed

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    Difluprednate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25228
    Active
    DIFLUPREDNATE (MICRONIZED)
    2011-08-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    301MF10046
    Difluprednate at Via Pavia, 1-27027...
    2019-08-20
    Written Confirmation

    Close WC

    Application Number
    25228
    301MF10046
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DIFLUPREDNATE (MICRONIZED)
    Difluprednate at Via Pavia, 1-27027...
    Issue/Submission Date
    2011-08-23
    2019-08-20
    Axplora CB

    Iran Expo

    Not Confirmed

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    Esmolol Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    6868
    Active
    ESMOLOL HYDROCHLORIDE
    1987-01-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0019A3
    Valid
    Esmolol Hydrochloride IH
    2022-07-15
    Application Number
    6868
    Indian CDSCO WC-0019A3
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-05-28
    Filing Details
    ESMOLOL HYDROCHLORIDE
    Esmolol Hydrochloride IH
    Issue/Submission Date
    1987-01-20
    2022-07-15
    Axplora CB

    Iran Expo

    Not Confirmed

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    Exemestane

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26291
    Active
    EXEMESTANE MICRONIZED USP
    2012-07-26
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-274 - Rev 00
    Valid
    Exemestane, micronized, non microni...
    2020-12-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26291
    R0-CEP 2018-274 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    EXEMESTANE MICRONIZED USP
    Exemestane, micronized, non microni...
    Issue/Submission Date
    2012-07-26
    2020-12-18
    Axplora CB

    Iran Expo

    Not Confirmed

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    Fludrocortisone Acetate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    14136
    Active
    FLUDROCORTISONE ACETATE
    1999-05-12
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-084 - Rev 00
    Valid
    Fludrocortisone acetate, Micronised
    2020-11-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14136
    R0-CEP 2019-084 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FLUDROCORTISONE ACETATE
    Fludrocortisone acetate, Micronised
    Issue/Submission Date
    1999-05-12
    2020-11-18
    Axplora CB

    Iran Expo

    Not Confirmed

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    Fluocinonide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    21430
    Active
    FLUOCINONIDE, MICRONIZED BP/USP
    2008-03-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10444
    Fluocinonide at Via Pavia, 1-27027 ...
    2006-04-27
    Written Confirmation

    Close WC

    Application Number
    21430
    218MF10444
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FLUOCINONIDE, MICRONIZED BP/USP
    Fluocinonide at Via Pavia, 1-27027 ...
    Issue/Submission Date
    2008-03-13
    2006-04-27
    Axplora CB

    Iran Expo

    Not Confirmed

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    Flurandrenolone

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    16492
    Active
    FLURANDRENOLIDE
    2003-03-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    220MF10142
    Flurandrenolide at Via Pavia, 1-270...
    2008-06-10
    Written Confirmation

    Close WC

    Application Number
    16492
    220MF10142
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FLURANDRENOLIDE
    Flurandrenolide at Via Pavia, 1-270...
    Issue/Submission Date
    2003-03-26
    2008-06-10
    Axplora CB

    Iran Expo

    Not Confirmed

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    Fluticasone Propionate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20463
    Active
    FLUTICASONE PROPIONATE USP/PH.EUR. ...
    2007-04-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-117 - Rev 01
    Valid
    Fluticasone propionate, Micronised ...
    2016-12-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20463
    R1-CEP 2008-117 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FLUTICASONE PROPIONATE USP/PH.EUR. ...
    Fluticasone propionate, Micronised ...
    Issue/Submission Date
    2007-04-24
    2016-12-09
    Axplora CB

    Iran Expo

    Not Confirmed

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    Formoterol Fumarate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    32936
    Active
    FORMOTEROL FUMARATE
    2018-07-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-132 - Rev 01
    Valid
    Formoterol fumarate dihydrate, Micr...
    2017-08-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32936
    R1-CEP 2010-132 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FORMOTEROL FUMARATE
    Formoterol fumarate dihydrate, Micr...
    Issue/Submission Date
    2018-07-27
    2017-08-11
    Axplora CB

    Iran Expo

    Not Confirmed

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    Fulvestrant

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    32949
    Active
    FULVESTRANT
    2018-07-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-169 - Rev 00
    Valid
    Fulvestrant
    2023-02-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32949
    R1-CEP 2016-169 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FULVESTRANT
    Fulvestrant
    Issue/Submission Date
    2018-07-27
    2023-02-22
    Axplora CB

    Iran Expo

    Not Confirmed

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    L-Cysteine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1997-014 - Rev 03
    Valid
    Cysteine Hydrochloride Monohydrate
    2014-04-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0102
    Valid
    L-Cysteine HCl Monohydrate Ph. Eur
    2022-06-24
    Application Number
    R1-CEP 1997-014 - Rev 03
    Indian CDSCO WC-0102
    Status
    Valid
     
    Valid
    2025-07-02
    Filing Details
    Cysteine Hydrochloride Monohydrate
    L-Cysteine HCl Monohydrate Ph. Eur
    Issue/Submission Date
    2014-04-24
    2022-06-24
    Axplora CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
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    Medroxyprogesterone Acetate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    12695
    Active
    MEDROXYPROGESTERONE ACETATE
    1997-10-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10098
    Medroxyprogesterone acetate at Via ...
    2010-03-17
    Written Confirmation

    Close WC

    Application Number
    12695
    222MF10098
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MEDROXYPROGESTERONE ACETATE
    Medroxyprogesterone acetate at Via ...
    Issue/Submission Date
    1997-10-15
    2010-03-17
    Axplora CB

    Iran Expo

    Not Confirmed

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    Megestrol Acetate

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    USDMF

    Found USDMF

    12662
    Active
    MEGESTROL ACETATE
    1997-09-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-154 - Rev 05
    Valid
    Megestrol acetate, Fine powder
    2019-02-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12662
    R1-CEP 2002-154 - Rev 05
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MEGESTROL ACETATE
    Megestrol acetate, Fine powder
    Issue/Submission Date
    1997-09-20
    2019-02-11
    Axplora CB

    Iran Expo

    Not Confirmed

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    Mometasone Furoate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22319
    Active
    MOMETASONE FUROATE
    2008-12-18
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-111 - Rev 00
    Valid
    Mometasone furoate, Micronised
    2018-08-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22319
    R1-CEP 2012-111 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MOMETASONE FUROATE
    Mometasone furoate, Micronised
    Issue/Submission Date
    2008-12-18
    2018-08-27
    Axplora CB

    Iran Expo

    Not Confirmed

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    Paclitaxel

    PDF Supplier PDF
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    USDMF

    Found USDMF

    12294
    Active
    PACLITAXEL
    1996-12-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-327 - Rev 00
    Valid
    Paclitaxel, Produced by a semi-synt...
    2014-09-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12294
    R1-CEP 2008-327 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PACLITAXEL
    Paclitaxel, Produced by a semi-synt...
    Issue/Submission Date
    1996-12-27
    2014-09-02
    Axplora CB

    Iran Expo

    Not Confirmed

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    Prednisolone Acetate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    32896
    Active
    STERILE PREDNISOLONE-21-ACETATE MIC...
    2018-07-16
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-109 - Rev 00
    Valid
    Prednisolone acetate
    2020-06-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32896
    R0-CEP 2019-109 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    STERILE PREDNISOLONE-21-ACETATE MIC...
    Prednisolone acetate
    Issue/Submission Date
    2018-07-16
    2020-06-02
    Axplora CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
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    Teriflunomide

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    30220
    Active
    TERIFLUNOMIDE
    2016-03-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0019A3
    Valid
    Teriflunomide IH
    2022-07-15
    Application Number
    30220
    Indian CDSCO WC-0019A3
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-05-28
    Filing Details
    TERIFLUNOMIDE
    Teriflunomide IH
    Issue/Submission Date
    2016-03-10
    2022-07-15
    Axplora CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
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    Triamcinolone Hexacetonide

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    17758
    Active
    TRIAMCINOLONE HEXACETONIDE
    2004-10-15
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-282 - Rev 02
    Valid
    Triamcinolone hexacetonide, Microni...
    2022-05-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17758
    R0-CEP 2018-282 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    TRIAMCINOLONE HEXACETONIDE
    Triamcinolone hexacetonide, Microni...
    Issue/Submission Date
    2004-10-15
    2022-05-30
    Axplora CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
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    Virtual BoothAxplora- The partner of choice for complex APIs.

    Ursodeoxycholic Acid

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2009-212 - Rev 00
    Valid
    Ursodeoxycholic acid
    2015-10-26
    Japanese DMF

    Found JDMF

    303MF10073
    Ursodeoxycholic acid URSODEOXYCHOLI...
    2021-04-27
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2009-212 - Rev 00
    303MF10073
    Status
    Valid
     
    Filing Details
    Ursodeoxycholic acid
    Ursodeoxycholic acid URSODEOXYCHOLI...
    Issue/Submission Date
    2015-10-26
    2021-04-27
    Axplora CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
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    Virtual BoothAxplora- The partner of choice for complex APIs.

    Beclomethasone Dipropionate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    21972
    Active
    BECLOMETASONE DIPROPIONATE MONOHYDR...
    2008-09-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21972
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BECLOMETASONE DIPROPIONATE MONOHYDR...
    Issue/Submission Date
    2008-09-11
    Axplora CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
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    Virtual BoothAxplora- The partner of choice for complex APIs.

    Cefuroxime Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    18722
    Active
    CEFUROXIME SODIUM STERILE USP
    2005-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18722
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CEFUROXIME SODIUM STERILE USP
    Issue/Submission Date
    2005-09-01
    Axplora CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
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    Clocortolone Pivalate

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    22421
    Active
    CLOCORTOLONE PIVALATE (MICRONIZED)
    2009-01-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22421
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CLOCORTOLONE PIVALATE (MICRONIZED)
    Issue/Submission Date
    2009-01-21
    Axplora CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
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    Desonide

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    19574
    Active
    DESONIDE DRUG SUBSTANCE
    2006-07-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19574
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DESONIDE DRUG SUBSTANCE
    Issue/Submission Date
    2006-07-06
    Axplora CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
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    Desoximetasone

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    17759
    Active
    DESOXIMETASONE
    2004-10-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17759
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DESOXIMETASONE
    Issue/Submission Date
    2004-10-18
    Axplora CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
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    Flumethasone

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    15534
    Active
    FLUMETHASONE
    2001-07-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15534
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FLUMETHASONE
    Issue/Submission Date
    2001-07-18
    Axplora CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
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    Flunisolide

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    19477
    Active
    FLUNISOLIDE ANHYDROUS USP
    2006-05-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19477
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FLUNISOLIDE ANHYDROUS USP
    Issue/Submission Date
    2006-05-31
    Axplora CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
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    Flunisolide

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    26148
    Active
    FLUNISOLIDE HEMIHYDRATE (MICRONIZED...
    2012-06-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26148
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FLUNISOLIDE HEMIHYDRATE (MICRONIZED...
    Issue/Submission Date
    2012-06-12
    Axplora CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
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    Halcinonide

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    18352
    Active
    HALCINONIDE
    2005-05-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18352
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    HALCINONIDE
    Issue/Submission Date
    2005-05-13
    Axplora CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
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    Melphalan Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    25791
    Active
    MELPHALAN HYDROCHLORIDE
    2012-02-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25791
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MELPHALAN HYDROCHLORIDE
    Issue/Submission Date
    2012-02-14
    Axplora CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
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    Methyl Testosterone

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    25593
    Active
    METHYLTESTOSTERONE (MICRONIZED)
    2011-12-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25593
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    METHYLTESTOSTERONE (MICRONIZED)
    Issue/Submission Date
    2011-12-15
    Axplora CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
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    Mivacurium Chloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    20232
    Active
    MIVACURIUM CHLORIDE
    2007-01-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20232
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MIVACURIUM CHLORIDE
    Issue/Submission Date
    2007-01-31
    Axplora CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
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    Triamcinolone Diacetate

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    USDMF

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    17561
    Active
    TRIAMCINOLONE DIACETATE
    2004-07-23
    CEP/COS

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    Japanese DMF

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    Application Number
    17561
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TRIAMCINOLONE DIACETATE
    Issue/Submission Date
    2004-07-23
    Axplora CB

    Iran Expo

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    Zolpidem Tartrate

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    USDMF

    Found USDMF

    11764
    Active
    ZOLPIDEM TARTRATE MODIFIED SYNTHESI...
    1995-12-05
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    11764
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ZOLPIDEM TARTRATE MODIFIED SYNTHESI...
    Issue/Submission Date
    1995-12-05
    Axplora CB

    Iran Expo

    Not Confirmed

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