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    All Manufacturers, Suppliers, Distributors and Exporters of Sapropterin Dihydrochloride with Listed Dossiers of Finished Dosage Form listed on PharmaCompass.com

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    Biophore Sapropterin HCl

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    FAMAR CDMO- From early development to commercial manufacturing.

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    xyz-pharma-m-2024-09-09

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    Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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    Veranova: A CDMO that manages complexity with confidence.

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    xyz-pharma-m-2024-09-09

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    Chemistry

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    Also known as:
    Molecular Formula
    C9H17Cl2N5O3
    Molecular Weight
    314.17  g/mol
    InChI Key
    RKSUYBCOVNCALL-NTVURLEBSA-N
    Sapropterin Hydrochloride
    1 2D Structure

    Sapropterin Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-1H-pteridin-4-one;dihydrochloride
    2.1.2 InChI
    InChI=1S/C9H15N5O3.2ClH/c1-3(15)6(16)4-2-11-7-5(12-4)8(17)14-9(10)13-7;;/h3-4,6,12,15-16H,2H2,1H3,(H4,10,11,13,14,17);2*1H/t3-,4+,6-;;/m0../s1
    2.1.3 InChI Key
    RKSUYBCOVNCALL-NTVURLEBSA-N
    2.1.4 Canonical SMILES
    CC(C(C1CNC2=C(N1)C(=O)N=C(N2)N)O)O.Cl.Cl
    2.1.5 Isomeric SMILES
    C[C@@H]([C@@H]([C@H]1CNC2=C(N1)C(=O)N=C(N2)N)O)O.Cl.Cl
    2.2 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 314.17 g/mol
    Molecular Formula C9H17Cl2N5O3
    Hydrogen Bond Donor Count8
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count2
    Exact Mass313.0708448 g/mol
    Monoisotopic Mass313.0708448 g/mol
    Topological Polar Surface Area132 A^2
    Heavy Atom Count19
    Formal Charge0
    Complexity405
    Isotope Atom Count0
    Defined Atom Stereocenter Count3
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3

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    01

    Biophore India Pharmaceuticals Pvt L...

    India
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    CPhI Worldwide, Milan
    Booth# 24A31
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2021-10-18

    Pay. Date : 2021-09-28

    DMF Number : 36147

    Submission : 2021-07-31

    Status : Active

    Type : II

    Biophore

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    26th North American ISSX
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    Asymchem Laboratories Tianjin Co Ltd

    U.S.A
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    26th North American ISSX
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 28416

    Submission : 2014-06-20

    Status : Active

    Type : II

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    Dipharma Sa

    Italy

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    Dipharma Sa

    Italy
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    26th North American ISSX
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    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-03-04

    Pay. Date : 2013-09-23

    DMF Number : 26682

    Submission : 2012-12-06

    Status : Active

    Type : II

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    Dipharma Sa

    Switzerland

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    Dipharma Sa

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    DMF Review : Complete

    Rev. Date : 2020-08-26

    Pay. Date : 2020-06-15

    DMF Number : 34926

    Submission : 2020-06-17

    Status : Active

    Type : II

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    Honour Lab Ltd

    India

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    26th North American ISSX
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    Honour Lab Ltd

    India
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    26th North American ISSX
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    GDUFA

    DMF Review : Complete

    Rev. Date : 2019-09-20

    Pay. Date : 2019-07-26

    DMF Number : 33928

    Submission : 2019-08-06

    Status : Active

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    Innopharmax Inc

    Taiwan

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    Innopharmax Inc

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2020-06-23

    Pay. Date : 2019-03-22

    DMF Number : 33553

    Submission : 2019-02-19

    Status : Active

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    26th North American ISSX
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    Shiratori Pharmceutical Co Ltd

    Japan
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17569

    Submission : 2004-07-20

    Status : Inactive

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    Solara Active Pharma Sciences Ltd

    India
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    GDUFA

    DMF Review : Complete

    Rev. Date : 2020-03-13

    Pay. Date : 2019-12-13

    DMF Number : 34185

    Submission : 2019-10-03

    Status : Active

    Type : II

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    API Reference Price

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    11-Jan-2021
    29-Jun-2024
    KGS
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    01

    Dipharma Francis S.r.l

    Italy
    26th North American ISSX
    Not Confirmed
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    Dipharma Francis S.r.l

    Italy
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    26th North American ISSX
    Not Confirmed
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    Regulatory Info :

    Registration Country : Italy

    sapropterin 2HCl

    Brand Name : Diterin

    Dosage Form : Tablet

    Dosage Strength : 100mg

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    Regulatory Info :

    Registration Country : Italy

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    01

    Dipharma Francis S.r.l

    Italy
    26th North American ISSX
    Not Confirmed
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    Dipharma Francis S.r.l

    Italy
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    26th North American ISSX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Packaging :

    Regulatory Info :

    sapropterin 2HCl

    Dosage : Tablet

    Dosage Strength : 100mg

    Brand Name : Diterin

    Approval Date :

    Application Number :

    Registration Country : Italy

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