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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

    • Balsalazide Disodium

    • Beclomethasone Dipropionate

    • Carbocisteine

    • Carbocysteine Lysine

    • Lysine

    • Lysine Acetate

    • Lysine Hydrochloride

    • Mesalazine

    • Methylene Blue

    • Olaparib

    • Propafenone Hydrochloride

    • Triamcinolone

    • Triamcinolone Acetonide

    • Triamcinolone Diacetate

    • Triamcinolone Hexacetonide

    • Ursodeoxycholic Acid

    • Zavegepant HCl

    INTERMEDIATES

    SERVICES

    Key Products KEY SERVICES

    • Complex API Development Services

    • CDMO for Small Molecule APIs

    • API Custom Synthesis

    • Hazardous Chemistry

    • Flow Chemistry

    • Industrial Chromatography

    • Contract Development & Manufacturing for ADCs

    EXCIPIENTS

    INSPECTIONS & REGISTRATIONS

    PharmaCompass
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    • FDA
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    Mesalazine

    PDF Supplier PDF
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    Other DMF EU, CA, TW, BR, TH
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    USDMF

    Found USDMF

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

    Found CEP/COS

    CEP 2003-203 - Rev 03
    Valid
    Mesalazine
    2023-11-08
    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
    CEP 2003-203 - Rev 03
    219MF10036
    Indian CDSCO WC-0019
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-05-28
    Filing Details
    5-AMINOSALICYLIC ACID (MESALAZINE/M...
    Mesalazine
    Mesalazine at ROSENHEIMER STR. 43 D...
    Mesalazine Ph. Eur & Mesalamine USP...
    Issue/Submission Date
    1989-05-09
    2023-11-08
    2007-02-13
    2022-03-18
    Axplora CB

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    Acetylcysteine

    PDF Supplier PDF
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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

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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

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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 at Plot No....
    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 at Plot No....
    Issue/Submission Date
    2017-05-19
    2013-11-14
    2022-06-24
    Axplora CB

    ChemOutsourcing

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    Celecoxib

    PDF Supplier PDF
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    Other DMF EU, CA
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    See Less

    USDMF

    Found USDMF

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

    Found CEP/COS

    CEP 2012-151 - Rev 02
    Valid
    Celecoxib
    2023-11-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0019
    Valid
    Celecoxib (USP/Ph. Eur.) at Plot No...
    2022-03-18
    Application Number
    26356
    CEP 2012-151 - Rev 02
    Indian CDSCO WC-0019
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-05-28
    Filing Details
    CELECOXIB USP
    Celecoxib
    Celecoxib (USP/Ph. Eur.) at Plot No...
    Issue/Submission Date
    2012-08-20
    2023-11-09
    2022-03-18
    Axplora CB

    ChemOutsourcing

    Booth #58

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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

    ChemOutsourcing

    Booth #58

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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

    ChemOutsourcing

    Booth #58

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    Medroxyprogesterone Acetate

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    USDMF

    Found USDMF

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

    Found CEP/COS

    R1-CEP 2002-191 - Rev 03
    Valid
    Medroxyprogesterone acetate, Micron...
    2023-07-03
    Japanese DMF

    Found JDMF

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

    Close WC

    Application Number
    12695
    R1-CEP 2002-191 - Rev 03
    222MF10098
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MEDROXYPROGESTERONE ACETATE
    Medroxyprogesterone acetate, Micron...
    Medroxyprogesterone acetate at Via ...
    Issue/Submission Date
    1997-10-15
    2023-07-03
    2010-03-17
    Axplora CB

    ChemOutsourcing

    Booth #58

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    Propafenone Hydrochloride

    PDF Supplier PDF
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    Other DMF EU, CA, BR, TH, ID
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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

    ChemOutsourcing

    Booth #58

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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

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

    Found JDMF

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

    Close WC

    Application Number
    14693
    R0-CEP 2021-315 - Rev 00
    305MF10085
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TRIAMCINOLONE ACETONIDE
    Triamcinolone acetonide, Process 2,...
    Triamcinolone Acetonide at Via Pavi...
    Issue/Submission Date
    2000-02-01
    2021-12-21
    2023-07-19
    Axplora CB

    ChemOutsourcing

    Booth #58

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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

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

    Found JDMF

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

    Close WC

    Application Number
    21591
    R1-CEP 2000-075 - Rev 07
    223MF10049
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TRIAMCINOLONE ACETONIDE MICRONIZED ...
    Triamcinolone acetonide, Micronised...
    Triamcinolone acetonide sterile at ...
    Issue/Submission Date
    2008-05-01
    2021-02-25
    2011-04-12
    Axplora CB

    ChemOutsourcing

    Booth #58

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    Balsalazide Disodium

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    See all info for this product

    See Less

    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 at Plot No...
    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 at Plot No...
    Issue/Submission Date
    2003-02-17
    2022-06-24
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
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    Beclomethasone Dipropionate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF CN, SAU
    See all info for this product

    See Less

    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

    ChemOutsourcing

    Booth #58

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    Betamethasone Dipropionate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    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

    ChemOutsourcing

    Booth #58

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    Budesonide

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF SAU
    See all info for this product

    See Less

    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

    ChemOutsourcing

    Booth #58

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    Budesonide

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

    See Less

    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

    ChemOutsourcing

    Booth #58

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    Busulfan

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF SAU
    See all info for this product

    See Less

    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

    ChemOutsourcing

    Booth #58

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    Chlormadinone Acetate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2018-122 - Rev 03
    Valid
    Chlormadinone acetate, Micronised (...
    2023-09-07
    Japanese DMF

    Found JDMF

    218MF10991
    Chlormadinone Acetate at Via Pavia,...
    2006-12-18
    Written Confirmation

    Close WC

    Application Number
    CEP 2018-122 - Rev 03
    218MF10991
    Status
    Valid
     
    Filing Details
    Chlormadinone acetate, Micronised (...
    Chlormadinone Acetate at Via Pavia,...
    Issue/Submission Date
    2023-09-07
    2006-12-18
    Axplora CB

    ChemOutsourcing

    Booth #58

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    Cyproterone Acetate

    PDF Supplier PDF
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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

    ChemOutsourcing

    Booth #58

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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 at Plot No.B5 & B...
    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 at Plot No.B5 & B...
    Issue/Submission Date
    2017-01-23
    2022-06-24
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Difluprednate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    See all info for this product

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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

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Esmolol Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, CA
    See all info for this product

    See Less

    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 at Plot No...
    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 at Plot No...
    Issue/Submission Date
    1987-01-20
    2022-07-15
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Exemestane

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

    See Less

    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

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Fludrocortisone Acetate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    See all info for this product

    See Less

    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

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Fluocinonide

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    See all info for this product

    See Less

    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

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Flurandrenolone

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    See all info for this product

    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

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Fluticasone Propionate

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

    See Less

    USDMF

    Found USDMF

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

    Found CEP/COS

    CEP 2008-117 - Rev 02
    Valid
    Fluticasone propionate, Micronised
    2024-05-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20463
    CEP 2008-117 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FLUTICASONE PROPIONATE USP/PH.EUR. ...
    Fluticasone propionate, Micronised
    Issue/Submission Date
    2007-04-24
    2024-05-23
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Formoterol Fumarate

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

    See Less

    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

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Fulvestrant

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

    See Less

    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

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Indapamide

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    See all info for this product

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2007-138 - Rev 02
    Valid
    Indapamide
    2023-11-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0019
    Valid
    Indapamide (Ph. Eur.) at Plot No. 1...
    2022-03-18
    Application Number
    CEP 2007-138 - Rev 02
    Indian CDSCO WC-0019
    Status
    Valid
     
    Valid
    2025-05-28
    Filing Details
    Indapamide
    Indapamide (Ph. Eur.) at Plot No. 1...
    Issue/Submission Date
    2023-11-14
    2022-03-18
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    L-Cysteine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    See all info for this product

    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

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Megestrol Acetate

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

    See Less

    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

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Methylene Blue

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    See all info for this product

    See Less

    USDMF

    Found USDMF

    32900
    Active
    METHYLENE BLUE USP
    2023-09-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0019
    Valid
    Methylene Blue USP at Plot No. 115,...
    2022-03-18
    Application Number
    32900
    Indian CDSCO WC-0019
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-05-28
    Filing Details
    METHYLENE BLUE USP
    Methylene Blue USP at Plot No. 115,...
    Issue/Submission Date
    2023-09-21
    2022-03-18
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Methylprednisolone Acetate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    See all info for this product

    See Less

    USDMF

    Found USDMF

    27325
    Active
    METHYLPREDNISOLONE ACETATE STERILE
    2013-07-19
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-429 - Rev 00
    Valid
    Methylprednisolone acetate, Microni...
    2023-06-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27325
    R0-CEP 2021-429 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    METHYLPREDNISOLONE ACETATE STERILE
    Methylprednisolone acetate, Microni...
    Issue/Submission Date
    2013-07-19
    2023-06-23
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Mometasone Furoate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF SAU
    See all info for this product

    See Less

    USDMF

    Found USDMF

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

    Found CEP/COS

    CEP 2018-297 - Rev 02
    Valid
    Mometasone furoate, Micronised, Alt...
    2023-10-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22319
    CEP 2018-297 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MOMETASONE FUROATE
    Mometasone furoate, Micronised, Alt...
    Issue/Submission Date
    2008-12-18
    2023-10-06
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Mometasone Furoate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF SAU
    See all info for this product

    See Less

    USDMF

    Found USDMF

    33446
    Active
    MOMETASONE FUROATE (ALTERNATE PROCE...
    2019-03-11
    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
    33446
    R1-CEP 2012-111 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MOMETASONE FUROATE (ALTERNATE PROCE...
    Mometasone furoate, Micronised
    Issue/Submission Date
    2019-03-11
    2018-08-27
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Paclitaxel

    PDF Supplier PDF
    URL Supplier Web Content
    NA Not Available For Sales
    See all info for this product

    See Less

    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

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Prednisolone Acetate

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

    See Less

    USDMF

    Found USDMF

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

    Found CEP/COS

    R0-CEP 2017-286 - Rev 01
    Valid
    Prednisolone acetate, Micronised, s...
    2020-07-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32896
    R0-CEP 2017-286 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    STERILE PREDNISOLONE-21-ACETATE MIC...
    Prednisolone acetate, Micronised, s...
    Issue/Submission Date
    2018-07-16
    2020-07-29
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Teriflunomide

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

    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 at Plot No. 115, R...
    2022-07-15
    Application Number
    30220
    Indian CDSCO WC-0019A3
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-05-28
    Filing Details
    TERIFLUNOMIDE
    Teriflunomide IH at Plot No. 115, R...
    Issue/Submission Date
    2016-03-10
    2022-07-15
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Triamcinolone Hexacetonide

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

    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

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Ursodeoxycholic Acid

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, BR
    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

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Cefuroxime Sodium

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

    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

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Desonide

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, CN
    See all info for this product

    See Less

    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

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Desoximetasone

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    See all info for this product

    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

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Flumethasone

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    See all info for this product

    See Less

    USDMF

    Found USDMF

    15534
    Active
    FLUMETHASONE
    2001-07-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

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

    ChemOutsourcing

    Booth #58

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    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Flunisolide

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    Other DMF EU
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    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

    ChemOutsourcing

    Booth #58

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    • FDA
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    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Halcinonide

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    Other DMF EU, CN
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    USDMF

    Found USDMF

    18352
    Active
    HALCINONIDE
    2005-05-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

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

    ChemOutsourcing

    Booth #58

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    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Mivacurium Chloride

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    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

    ChemOutsourcing

    Booth #58

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    • FDA
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    • WHO-GMP
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    Triamcinolone Diacetate

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    USDMF

    Found USDMF

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

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

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

    ChemOutsourcing

    Booth #58

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    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Zolpidem Tartrate

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    USDMF

    Found USDMF

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

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

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

    ChemOutsourcing

    Booth #58

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