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    LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    Sharp is a leader in commercial packaging, clinical services, and sterile manufacturing.

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    As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

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    Hainan Poly Pharm

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    01 1Calcobutrol Sodium

    02 1Calteridol Calcium

    03 1DOTA

    04 1Salcaprozate Sodium

    05 1Sulfobutylether-β-Cydodextrin (SBECD)

    06 1Blank

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    01

    Sulfobutylether-β-Cydodextrin (SBE...

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

    RDD
    Not Confirmed
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    Sulfobutylether-β-Cydodextrin (SBE...

    China

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

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    RDD
    Not Confirmed
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    • WHO-GMP
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37814

    Submission : 2022-12-28

    Status : Active

    Type : IV

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-504 - Rev 00

    Issue Date : 2024-07-03

    Type :

    Substance Number :

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    02

    Calcobutrol Sodium

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

    RDD
    Not Confirmed
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    Calcobutrol Sodium

    China

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

    arrow
    RDD
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39309

    Submission : 2023-12-29

    Status : Active

    Type : IV

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

    Calteridol Calcium

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

    RDD
    Not Confirmed
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    Calteridol Calcium

    China

    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 : 38106

    Submission : 2023-02-28

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    04

    DOTA

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

    RDD
    Not Confirmed
    arrow

    DOTA

    China

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

    arrow
    RDD
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37073

    Submission : 2022-05-31

    Status : Active

    Type : IV

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

    Salcaprozate Sodium

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

    RDD
    Not Confirmed
    arrow

    Salcaprozate Sodium

    China

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

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    RDD
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39651

    Submission : 2024-03-14

    Status : Active

    Type : IV

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

    SM-102 (HEPTADECAN-9-YL 8-((2-HYDRO...

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

    RDD
    Not Confirmed
    arrow

    SM-102 (HEPTADECAN-9-YL 8-((2-HYDRO...

    China

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

    arrow
    RDD
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 40905

    Submission : 2024-11-29

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Contact Hainan Poly Pharm and get a quotation

    Hainan Poly Pharm is a supplier offers 42 products (APIs, Excipients or Intermediates).

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    • Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.