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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 1Amifampridine

    02 1Cerliponase Alpha

    03 1Elosulfase Alpha

    04 1Galsulfase

    05 3Pegvaliase

    06 2Sapropterin

    07 1Sapropterin Dihydrochloride

    08 1Sapropterina

    09 1Valoctocogen Roxaparvovec

    10 3Vosoritide

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    Brand Name : Firdapse

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    Brand Name : Firdapse

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    Regulatory Info :

    Registration Country : Norway

    Amifampridine

    BioMarin Pharmaceutical

    Dosage Form : Antic-calc Tablet

    Dosage Strength : 10 mg

    Packaging : Blister

    Brand Name : Firdapse

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    Registration Country : Norway

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    Brand Name : Kuvan

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    Brand Name : Kuvan

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    Regulatory Info :

    Registration Country : Norway

    Sapropterin Dihydrochloride

    BioMarin Pharmaceutical

    Dosage Form : Soluble Antic-Calc tablet

    Dosage Strength : 100 mg

    Packaging : Bottle

    Brand Name : Kuvan

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    Registration Country : Norway

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    03

    Brand Name : KUVAN

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    Regulatory Info :

    Registration Country : Italy

    Sapropterin

    BioMarin Pharmaceutical

    Dosage Form : Soluble Tablets

    Dosage Strength : 100mg

    Packaging : 120 UNITS 100 MG -...

    Brand Name : KUVAN

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    Registration Country : Italy

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    Regulatory Info :

    Registration Country : Italy

    Sapropterin

    BioMarin Pharmaceutical

    Dosage Form : Soluble Tablets

    Dosage Strength : 100mg

    Packaging : 30 UNITS 100 MG - ...

    Brand Name : KUVAN

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    Registration Country : Italy

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    05

    Brand Name : Brineura

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    Brand Name : Brineura

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    Regulatory Info : Authorized

    Registration Country : Spain

    Cerliponase Alpha

    BioMarin Pharmaceutical

    Dosage Form : Solution For Perfusion

    Dosage Strength : 150MG

    Packaging :

    Brand Name : Brineura

    Approval Date : 2019-06-21

    Application Number : 1171192001

    Regulatory Info : Authorized

    Registration Country : Spain

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    06

    Brand Name : Vimizim

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    Brand Name : Vimizim

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    Regulatory Info : Authorized

    Registration Country : Spain

    Elosulfase Alpha

    BioMarin Pharmaceutical

    Dosage Form : Concentrate For Infusion Solut...

    Dosage Strength : 1MG

    Packaging :

    Brand Name : Vimizim

    Approval Date : 2015-03-23

    Application Number : 114914001

    Regulatory Info : Authorized

    Registration Country : Spain

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    07

    Brand Name : Palynziq

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    Brand Name : Palynziq

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    Regulatory Info : Authorized

    Registration Country : Spain

    Pegvaliase

    BioMarin Pharmaceutical

    Dosage Form : Injectable Solution In Pre-Fil...

    Dosage Strength : 2.5MG

    Packaging :

    Brand Name : Palynziq

    Approval Date : 2019-12-16

    Application Number : 1191362001

    Regulatory Info : Authorized

    Registration Country : Spain

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    Brand Name : Palynziq

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    Brand Name : Palynziq

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    Regulatory Info : Authorized

    Registration Country : Spain

    Pegvaliase

    BioMarin Pharmaceutical

    Dosage Form : Injectable Solution In Pre-Fil...

    Dosage Strength : 20MG

    Packaging :

    Brand Name : Palynziq

    Approval Date : 2020-04-07

    Application Number : 1191362004

    Regulatory Info : Authorized

    Registration Country : Spain

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    09

    Brand Name : Naglazyme

    U.S.A
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    Brand Name : Naglazyme

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    Regulatory Info : Authorized

    Registration Country : Spain

    Galsulfase

    BioMarin Pharmaceutical

    Dosage Form : Concentrate For Infusion Solut...

    Dosage Strength : 1MG

    Packaging :

    Brand Name : Naglazyme

    Approval Date : 2006-06-19

    Application Number : 05324001

    Regulatory Info : Authorized

    Registration Country : Spain

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    10

    Brand Name : Palynziq

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    Brand Name : Palynziq

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    Regulatory Info : Authorized

    Registration Country : Spain

    Pegvaliase

    BioMarin Pharmaceutical

    Dosage Form : Injectable Solution In Pre-Fil...

    Dosage Strength : 10MG

    Packaging :

    Brand Name : Palynziq

    Approval Date : 2020-03-10

    Application Number : 1191362002

    Regulatory Info : Authorized

    Registration Country : Spain

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