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

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    ALKERMES PLC

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    Alkermes Plc
    Ireland Flag
    Country
    Country
    Ireland
    Address
    Address
    Connaught House, 1 Burlington Road, Dublin 4, Ireland
    Telephone
    Telephone
    +353 1 772 8000
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.alkermes.com/
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    Linkedin
    https://www.linkedin.com/company/alkermes/?originalSubdomain=in
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    Sirolimus

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    USDMF

    Found USDMF

    12571
    Active
    RAPAMYCIN NANOCRYSTAL COLLOIDAL DIS...
    1997-07-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10176
    Rapamycin NanoCrystal Colloidal Dis...
    2013-09-18
    Written Confirmation

    Close WC

    Application Number
    12571
    225MF10176
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    RAPAMYCIN NANOCRYSTAL COLLOIDAL DIS...
    Rapamycin NanoCrystal Colloidal Dis...
    Issue/Submission Date
    1997-07-09
    2013-09-18
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    Dead On Polystyrene

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    USDMF

    Found USDMF

    29273
    Active
    POLYMILL ® POLYSTYRENE MILLING MED...
    2015-07-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    29273
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    POLYMILL ® POLYSTYRENE MILLING MED...
    Issue/Submission Date
    2015-07-15
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    Dimethyl Sulfoxide

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    USDMF

    Found USDMF

    22739
    Active
    MICROSPHERE DILUENT
    2009-05-05
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    22739
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    MICROSPHERE DILUENT
    Issue/Submission Date
    2009-05-05
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    Glycolide - lactide copolymer

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    223MF20001
    Medisorb 5050 DL 4AP at 852 Winter ...
    2011-03-10
    Written Confirmation

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    Application Number
    223MF20001
    Status
     
    Filing Details
    Medisorb 5050 DL 4AP at 852 Winter ...
    Issue/Submission Date
    2011-03-10
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    Meloxicam

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    USDMF

    Found USDMF

    29935
    Active
    NCD MELOXICAM BULK INTERMEDIATE
    2015-12-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    29935
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    NCD MELOXICAM BULK INTERMEDIATE
    Issue/Submission Date
    2015-12-07
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    Dl-Threo-3,4-Dihydroxyphenylserine

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    USDMF

    Caution USDMF

    22903
    Inactive
    ELN-CT-105G
    2009-06-23
    CEP/COS

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    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    22903
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ELN-CT-105G
    Issue/Submission Date
    2009-06-23
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    Fluvoxamine

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    USDMF

    Caution USDMF

    13957
    Inactive
    FLUVOXAMINE MALEATE CR CAPSULES
    1999-01-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    13957
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    FLUVOXAMINE MALEATE CR CAPSULES
    Issue/Submission Date
    1999-01-22
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    Meloxicam

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    USDMF

    Caution USDMF

    18805
    Inactive
    MELOXICAM NANOCRYSTAL® TABLETS
    2005-09-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18805
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    MELOXICAM NANOCRYSTAL® TABLETS
    Issue/Submission Date
    2005-09-26
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    Morphine Sulfate

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    USDMF

    Caution USDMF

    16433
    Inactive
    AVINZA((R) (MORPHINE SULFATE EXTEND...
    2003-02-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    16433
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    AVINZA((R) (MORPHINE SULFATE EXTEND...
    Issue/Submission Date
    2003-02-21
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    • FDA
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    PROLEASE DILUENT USED FOR SUSPENSION OF PROLEASE MICROS...

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    USDMF

    Caution USDMF

    14028
    Inactive
    PROLEASE DILUENT USED FOR SUSPENSIO...
    1999-03-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14028
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    PROLEASE DILUENT USED FOR SUSPENSIO...
    Issue/Submission Date
    1999-03-18
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    ELND-005

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    USDMF

    Caution USDMF

    20561
    Inactive
    ELND-005
    2007-06-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20561
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ELND-005
    Issue/Submission Date
    2007-06-25
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    • FDA
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    N1679 NANOCRYSTAL CAPSULE

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    USDMF

    Caution USDMF

    22755
    Inactive
    N1679 NANOCRYSTAL CAPSULE
    2009-05-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22755
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    N1679 NANOCRYSTAL CAPSULE
    Issue/Submission Date
    2009-05-01
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    N1714 TABLETS

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    USDMF

    Caution USDMF

    24632
    Inactive
    N1714 TABLETS
    2011-02-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24632
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    N1714 TABLETS
    Issue/Submission Date
    2011-02-14
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    • FDA
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    N1752 EXTENDED RELEASE TABLETS, 18MG

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    USDMF

    Caution USDMF

    26361
    Inactive
    N1752 EXTENDED RELEASE TABLETS, 18M...
    2012-08-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26361
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    N1752 EXTENDED RELEASE TABLETS, 18M...
    Issue/Submission Date
    2012-08-28
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