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    Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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    BioMarin Pharmaceutical

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    01 1CERLIPONASE ALFA

    02 1ELOSULFASE ALFA

    03 1GALSULFASE

    04 1LARONIDASE

    05 3PEGVALIASE-PQPZ

    06 3SAPROPTERIN DIHYDROCHLORIDE

    07 3VOSORITIDE

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    01

    Brand Name : BRINEURA

    U.S.A
    OPRD
    Not Confirmed
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    02

    Brand Name : VIMIZIM

    U.S.A
    OPRD
    Not Confirmed
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    03

    Brand Name : NAGLAZYME

    U.S.A
    OPRD
    Not Confirmed
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    Brand Name : NAGLAZYME

    U.S.A
    OPRD
    Not Confirmed
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    RLD :

    TE Code :

    GALSULFASE

    BioMarin Pharmaceutical

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : NAGLAZYME

    Dosage Strength : 5MG/5ML

    Approval Date :

    Application Number : 125117

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    04

    Brand Name : ALDURAZYME

    U.S.A
    OPRD
    Not Confirmed
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    05

    Brand Name : PALYNZIQ

    U.S.A
    OPRD
    Not Confirmed
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    Brand Name : PALYNZIQ

    U.S.A
    OPRD
    Not Confirmed
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    RLD :

    TE Code :

    PEGVALIASE-PQPZ

    BioMarin Pharmaceutical

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : PALYNZIQ

    Dosage Strength : 2.5MG/O.5ML

    Approval Date :

    Application Number : 761079

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    06

    Brand Name : PALYNZIQ

    U.S.A
    OPRD
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    Brand Name : PALYNZIQ

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    RLD :

    TE Code :

    PEGVALIASE-PQPZ

    BioMarin Pharmaceutical

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : PALYNZIQ

    Dosage Strength : 10MG/0.5ML

    Approval Date :

    Application Number : 761079

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    07

    Brand Name : PALYNZIQ

    U.S.A
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    08

    Brand Name : KUVAN

    U.S.A
    OPRD
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    09

    Brand Name : KUVAN

    U.S.A
    OPRD
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    Brand Name : KUVAN

    U.S.A
    OPRD
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    RLD : Yes

    TE Code : AB

    SAPROPTERIN DIHYDROCHLORIDE

    BioMarin Pharmaceutical

    Dosage Form : POWDER; ORAL

    Proprietary Name : KUVAN

    Dosage Strength : 100MG/PACKET

    Approval Date : 2013-12-19

    Application Number : 205065

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    10

    Brand Name : KUVAN

    U.S.A
    OPRD
    Not Confirmed
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    Brand Name : KUVAN

    U.S.A
    OPRD
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    • EDQM
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    RLD : Yes

    TE Code : AB

    SAPROPTERIN DIHYDROCHLORIDE

    BioMarin Pharmaceutical

    Dosage Form : POWDER; ORAL

    Proprietary Name : KUVAN

    Dosage Strength : 500MG/PACKET

    Approval Date : 2015-10-27

    Application Number : 205065

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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