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    01 2Bromfenac

    02 2Capecitabine

    03 1Choline

    04 5Choline Alfoscerate

    05 1Choline Chloride

    06 1Citicoline Sodium

    07 3Cytarabine

    08 1Diacerein

    09 1Dihydralazine Sulfate

    10 2Disopyramide

    11 1Favipiravir

    12 1Glycerophosphorylethanolamine

    13 2Hydralazine Hydrochloride

    14 2Hydroxyurea

    15 2Lithium Carbonate

    16 2Mianserin Hydrochloride

    17 2Oxcarbazepine

    18 3Pirenzepine

    19 2Sucralfate

    20 1Sucrose Octasulfate

    21 2Sulfapyridine

    22 1Sulfathiazole Sodium

    23 1Thenyldiamine

    24 1Tolmetin

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    01

    Cytarabine

    Italy

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

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    PEGS Boston Summit
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    • fda
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    Virtual BoothArchimica: Excellence in complex chemical technologies, regulatory-approved manufacturing, and API innovation.
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    USDMF arrow-down Click Us! arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-12-18

    Pay. Date : 2013-01-15

    DMF Number : 25267

    Submission : 2011-09-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-289 - Rev 00

    Issue Date : 2024-02-06

    Type : Chemical

    Substance Number : 760

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    02

    Hydroxyurea

    Italy

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

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    PEGS Boston Summit
    Not Confirmed
    • fda
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    Virtual BoothArchimica: Excellence in complex chemical technologies, regulatory-approved manufacturing, and API innovation.
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-02-13

    Pay. Date : 2019-02-08

    DMF Number : 12754

    Submission : 1997-11-14

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2003-120 - Rev 03

    Issue Date : 2020-09-18

    Type : Chemical

    Substance Number : 1616

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    03

    Bromfenac

    Italy

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-07-31

    Pay. Date : 2013-07-18

    DMF Number : 23704

    Submission : 2010-04-12

    Status : Active

    Type : II

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    04

    Capecitabine

    Italy

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

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25266

    Submission : 2011-09-07

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
    CB

    05

    Cytarabine

    Italy

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

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    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
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    Virtual BoothArchimica: Excellence in complex chemical technologies, regulatory-approved manufacturing, and API innovation.
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2000-048 - Rev 04

    Issue Date : 2020-10-16

    Type : Chemical

    Substance Number : 760

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    06

    Diacerein

    Italy

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

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    PEGS Boston Summit
    Not Confirmed
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    Virtual BoothArchimica: Excellence in complex chemical technologies, regulatory-approved manufacturing, and API innovation.
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2014-247 - Rev 01

    Issue Date : 2026-05-18

    Type : Chemical

    Substance Number : 2409

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
    CB

    07

    Disopyramide

    Italy

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

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    PEGS Boston Summit
    Not Confirmed
    • fda
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    Virtual BoothArchimica: Excellence in complex chemical technologies, regulatory-approved manufacturing, and API innovation.
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14204

    Submission : 1999-06-11

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    08

    Favipiravir

    India

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

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35933

    Submission : 2021-05-22

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    09

    Hydralazine Hydrochloride

    Italy

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

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    PEGS Boston Summit
    Not Confirmed
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    Virtual BoothArchimica: Excellence in complex chemical technologies, regulatory-approved manufacturing, and API innovation.
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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-02-27

    Pay. Date : 2014-04-25

    DMF Number : 22169

    Submission : 2008-10-31

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
    CB

    10

    Lithium Carbonate

    Italy

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
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    Virtual BoothArchimica: Excellence in complex chemical technologies, regulatory-approved manufacturing, and API innovation.
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    Flag India
    Virtual Booth Virtual Booth
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-07-08

    Pay. Date : 2013-03-25

    DMF Number : 23175

    Submission : 2009-10-07

    Status : Active

    Type : II

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    Contact Pi Health Sciences and get a quotation

    Pi Health Sciences is a supplier offers 23 products (APIs, Excipients or Intermediates).

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