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    DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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    Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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    Chemistry

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    Also known as:
    Molecular Formula
    C14H8N2Na2O6
    Molecular Weight
    346.20  g/mol
    InChI Key
    QQWFSVYVHLECFP-UHFFFAOYSA-L
    Olsalazine
    1 2D Structure

    Olsalazine

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    disodium;5-[2-(3-carboxy-4-oxocyclohexa-2,5-dien-1-ylidene)hydrazinyl]-2-oxidobenzoate
    2.1.2 InChI
    InChI=1S/C14H10N2O6.2Na/c17-11-3-1-7(5-9(11)13(19)20)15-16-8-2-4-12(18)10(6-8)14(21)22;;/h1-6,15,17H,(H,19,20)(H,21,22);;/q;2*+1/p-2
    2.1.3 InChI Key
    QQWFSVYVHLECFP-UHFFFAOYSA-L
    2.1.4 Canonical SMILES
    C1=CC(=C(C=C1NN=C2C=CC(=O)C(=C2)C(=O)O)C(=O)[O-])[O-].[Na+].[Na+]
    2.1.5 Isomeric SMILES
    C1=CC(=C(C=C1NN=C2C=CC(=O)C(=C2)C(=O)O)C(=O)[O-])[O-].[Na+].[Na+]
    2.2 Create Date
    2011-12-27
    3 Chemical and Physical Properties
    Molecular Weight 346.20 g/mol
    Molecular Formula C14H8N2Na2O6
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count3
    Exact Mass346.01777454 g/mol
    Monoisotopic Mass346.01777454 g/mol
    Topological Polar Surface Area142 A^2
    Heavy Atom Count24
    Formal Charge0
    Complexity587
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count1
    Covalently Bonded Unit Count3

    API SUPPLIERS

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    01

    Emcure Pharmaceuticals

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Antibody Engineering
    Not Confirmed
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    Emcure Pharmaceuticals

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Antibody Engineering
    Not Confirmed
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 27618

    Submission : 2013-12-27

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    02

    DOTTIKON EXCLUSIVE SYNTHESIS AG

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Antibody Engineering
    Not Confirmed
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    DOTTIKON EXCLUSIVE SYNTHESIS AG

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Antibody Engineering
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17677

    Submission : 2004-09-13

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    03

    Viatris

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Antibody Engineering
    Not Confirmed
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    Viatris

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Antibody Engineering
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39269

    Submission : 2023-12-20

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 65015-901

    Start Marketing Date : 2024-03-26

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    04

    Pfizer Inc

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Antibody Engineering
    Not Confirmed
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    Pfizer Inc

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Antibody Engineering
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 6443

    Submission : 1986-06-23

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    05

    Corden Pharma Bergamo S.p.A

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Antibody Engineering
    Not Confirmed
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    Corden Pharma Bergamo S.p.A

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Antibody Engineering
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21981

    Submission : 2008-09-08

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    06

    Emcure Pharmaceuticals

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Antibody Engineering
    Not Confirmed
    arrow

    Emcure Pharmaceuticals

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Antibody Engineering
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21633

    Submission : 2008-05-19

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2019-10-07

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0226

    Address of the Firm :

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    07

    Hengdian Group

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Antibody Engineering
    Not Confirmed
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