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    List of all Manufacturers, Suppliers & Exporters of Apalutamide API listed on PharmaCompass with details of regulatory filings

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    Apalutamide

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    01 Aarti Pharmalabs (1)

    02 Dr. Reddy's Laboratories (2)

    03 Shandong Chenghui Shuangda Pharmaceutical (1)

    04 Beijing Mesochem Technology (1)

    05 Alembic Pharmaceuticals Limited (1)

    06 Aurobindo Pharma Limited (1)

    07 Beijing Hope Pharmaceutical (1)

    08 BrightGene Bio-Medical Technology Co.,Ltd (1)

    09 Cipla (1)

    10 Egis Pharmaceuticals PLC (1)

    11 Fujian South Pharmaceutical (1)

    12 Hetero Drugs (1)

    13 Laurus Labs (1)

    14 MSN Laboratories (1)

    15 Olon S.p.A (1)

    16 Prajna Generics (1)

    17 Shandong Haohong Biotechnology Co.,ltd (1)

    18 Shanghai Hope Chem (1)

    19 Shenzhen HwaGen Pharmaceutical (1)

    20 Sichuan Qingmu Pharmaceutical (1)

    21 Teva API (1)

    22 Vannsh Life Sciences (1)

    23 Viatris (1)

    24 Zhejiang Tianyu Pharmaceutical Co., Ltd (1)

    25 Zydus Lifesciences (1)

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    01 China (10)

    02 Hungary (1)

    03 India (12)

    04 Israel (1)

    05 Italy (1)

    06 U.S.A (1)

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    02 WC-0390 (1)

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    Aarti Pharmalabs

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    • FDA
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    Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
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    Apalutamide

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    Aarti Industries Company Banner

    DDL 2023

    Not Confirmed

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    Dr. Reddy's Laboratories

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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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    Application Number
    34667
    Indian CDSCO WC-0390
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-11-30
    Filing Details
    APALUTAMIDE
    Apalutamide IH
    Issue/Submission Date
    2020-03-24
    2022-07-28
    Dr Reddy Company Banner

    DDL 2023

    Not Confirmed

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    Shandong Chenghui Shuangda Pharmace...

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      Virtual BoothShuangda Pharmaceutical has a world-class first-class production line, having GMP, FDA and other regulatory certifications.
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      Shandong Chenghui Shuangda Pharmaceutical

      CPhI China 2024

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      Beijing Mesochem Technology

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        Virtual BoothMesochem is focused on incessant innovation along with the R&D of new APIs.
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        Apalutamide

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        Beijing Mesochem Technology CB

        DDL 2023

        Not Confirmed

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        Dr. Reddy's Laboratories

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        Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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        Application Number
        35740
        Status
        Active
        Fees Paid
        N/A
         
        Filing Details
        APALUTAMIDE (AMORPHOUS)
        Issue/Submission Date
        2021-03-25
        Dr Reddy Company Banner

        DDL 2023

        Not Confirmed

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        Alembic Pharmaceuticals Limited

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        Application Number
        36028
        Status
        Active
        Fees Paid
        Reviewed
         
        Filing Details
        APALUTAMIDE
        Issue/Submission Date
        2021-09-22
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        MSN Laboratories

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        Application Number
        34711
        Indian CDSCO WC-0349A12
        Status
        Active
        Fees Paid
        Reviewed
         
        Expired
        2022-05-05
        Filing Details
        APALUTAMIDE
        Apalutamide IH
        Issue/Submission Date
        2020-03-31
        2021-04-23
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        Zydus Lifesciences

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        Application Number
        36264
        Status
        Active
        Fees Paid
        Reviewed
         
        Filing Details
        APALUTAMIDE
        Issue/Submission Date
        2021-09-09
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        Laurus Labs

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