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

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    01 AMBRISENTAN (1)

    02 ASENAPINE MALEATE (NON-STERILE DRUG SUBSTANCE) (1)

    03 BOSENTAN MONOHYDRATE (NON-STERILE DRUG SUBSTANCE) (1)

    04 CINACALCET HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) (1)

    05 DARIFENACIN HYDROBROMIDE (NON STERILE DRUG SUBSTANCE) (1)

    06 DONEPEZIL HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) (1)

    07 MEMANTINE HYDROCHLORIDE USP (1)

    08 MIRABEGRON DRUG SUBSTANCE (1)

    09 MIRTAZAPINE ANHYDROUS USP (NON-STERILE DRUG SUBSTANCE) (1)

    10 MIRTAZAPINE HEMIHYDRATE USP (NON STERILE DRUG SUBSTANCE) (1)

    11 PALIPERIDONE USP (NON- STERILE DRUG SUBSTANCE) (1)

    12 PRASUGREL HYDROCHLORIDE (1)

    13 PYRANTEL PAMOATE USP (NON STERILE DRUG SUBSTANCE) (1)

    14 QUETIAPINE HEMIFUMARATE USP (1)

    15 RIVAROXABAN (NON-STERILE DRUG SUBSTANCE) (1)

    16 SOLIFENACIN SUCCINATE (1)

    17 TERIFLUNOMIDE DRUG SUBSTANCE (1)

    18 VENLAFAXINE HYDROCHLORIDE USP (1)

    19 ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP (NON STERILE DRUG SUBSTANCE) (1)

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    01 MEGAFINE PHARMA P LTD (19)

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    01 India (19)

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    01 Active (19)

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    01 Complete (16)

    02 Blank (3)

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    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
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    AMBRISENTAN

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    Other DMF CN, RU, EU
    MEGAFINE PHARMA P LTD
    Active
    29792
    Complete
    2015-12-18
    2015-09-28
    2015-09-09
    II
    Megafine Pharma CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    ASENAPINE MALEATE (NON-STERILE DRUG...

    PDF Supplier PDF
    URL Supplier Web Content
    MEGAFINE PHARMA P LTD
    Active
    27292
    Complete
    2013-08-28
    2013-07-30
    2013-06-30
    II
    Megafine Pharma CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    BOSENTAN MONOHYDRATE (NON-STERILE D...

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, CA, AU, BR, CN
    MEGAFINE PHARMA P LTD
    Active
    25354
    Complete
    2014-08-20
    2013-09-26
    2011-09-30
    II
    Megafine Pharma CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    CINACALCET HYDROCHLORIDE (NON-STERI...

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, CA, AU, BR, CN
    MEGAFINE PHARMA P LTD
    Active
    24881
    Complete
    2013-02-23
    2012-12-24
    2011-04-22
    II
    Megafine Pharma CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    DARIFENACIN HYDROBROMIDE (NON STERI...

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, BR
    MEGAFINE PHARMA P LTD
    Active
    26533
    Complete
    2013-07-23
    2013-03-20
    2012-09-30
    II
    Megafine Pharma CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    DONEPEZIL HYDROCHLORIDE USP (NON-ST...

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF CA, AU, BR, CN
    MEGAFINE PHARMA P LTD
    Active
    22379
    Complete
    2013-10-07
    2013-09-26
    2008-12-25
    II
    Megafine Pharma CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    MEMANTINE HYDROCHLORIDE USP

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, CA, BR, MX, CN, RU
    MEGAFINE PHARMA P LTD
    Active
    25402
    Complete
    2013-08-22
    2013-04-15
    2011-10-14
    II
    Megafine Pharma CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    MIRABEGRON DRUG SUBSTANCE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, BR, CN
    MEGAFINE PHARMA P LTD
    Active
    29773
    Complete
    2016-02-05
    2015-09-30
    2015-09-25
    II
    Megafine Pharma CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    MIRTAZAPINE ANHYDROUS USP (NON-STER...

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF CA, AU, BR, MX
    MEGAFINE PHARMA P LTD
    Active
    20570
    N/A
    2007-05-28
    II
    Megafine Pharma CB

    Iran Expo

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    MIRTAZAPINE HEMIHYDRATE USP (NON ST...

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF CA, AU, BR, MX
    MEGAFINE PHARMA P LTD
    Active
    23003
    Complete
    2013-10-07
    2013-09-26
    2009-07-30
    II
    Megafine Pharma CB

    Iran Expo

    Not Confirmed

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