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

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    Bicalutamide

    APIs // Active Pharmaceutical Ingredients

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    01 Fareva (1)

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    Fareva

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    • FDA
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    Virtual BoothFareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
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    Bicalutamide

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    Application Number
    21863
    R1-CEP 2012-270 - Rev 02
    220MF10252
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BICALUTAMIDE MILLED Z
    Bicalutamide, Milled, Milled (Z)
    Bicalutamide at NUERNBERGER STRASSE...
    Issue/Submission Date
    2008-08-04
    2021-08-26
    2008-12-12
    Fareva Company Banner

    CPhI Japan

    Exhibiting

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    Aarti Pharmalabs

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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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    Found JDMF

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    Found WC

    Application Number
    20502
    R1-CEP 2012-223 - Rev 01
    227MF10159
    Indian CDSCO WC-0099
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-29
    Filing Details
    BICALUTAMIDE
    Bicalutamide
    Bicalutamide at 71, UDYOG KSHETRA, ...
    Bicalutamide Ph.Eur./USP
    Issue/Submission Date
    2007-05-01
    2022-11-21
    2015-06-18
    2023-01-06
    Aarti Industries Company Banner

    CPhI China

    Booth #E1C28

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    Zeon Pharma Industries India Pvt Lt...

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      Zeon Pharma Industries India Pvt Ltd Company Banner

      In-cosmetics Global

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      CF Pharma

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      Virtual BoothCF Pharma- skilled & highly experienced European API producer based in Hungary.
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      Bicalutamide

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      Application Number
      22158
      Status
      Inactive
      Fees Paid
      N/A
       
      Filing Details
      BICALUTAMIDE ADSORBATE
      Issue/Submission Date
      2008-11-04
      CF Pharma

      CPhI Japan

      Booth #5P-27

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      LGM Pharma

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

      CPhI North America

      Booth #642

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      HRV Global Life Sciences

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        Bicalutamide

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        HRV Global Life Sciences Company Banner

        In-cosmetics Global

        Not Confirmed

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        USV Private Limited

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        • FDA
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        Virtual BoothUSV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
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        Bicalutamide

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        Application Number
        219MF10379
        Indian CDSCO WC-0012
        Status
         
        Valid
        2025-06-02
        Filing Details
        Bicalutamide at Arvind Vithal Gandh...
        Bicalutamide IH/Ph . Eur.
        Issue/Submission Date
        2007-12-19
        2022-06-27
        USV Private Limited

        CPhI Worldwide, Milan

        Booth #10F41

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        Shilpa Medicare

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        Application Number
        24690
        225MF10084
        Indian CDSCO WC-0147
        Status
        Active
        Fees Paid
        Reviewed
         
        Expired
        2022-07-02
        Filing Details
        BICALUTAMIDE USP
        Bicalutamide at Shilpa House, #12-6...
        Bicalutamide (IH)
        Issue/Submission Date
        2011-05-11
        2013-04-23
        2019-07-05
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        Cipla

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        Application Number
        18723
        R1-CEP 2014-191 - Rev 00
        Indian CDSCO WC-0113
        Status
        Active
        Fees Paid
        N/A
        Valid
         
        Valid
        2025-08-08
        Filing Details
        BICALUTAMIDE USP
        Bicalutamide
        Bicalutamide (USP/BP)
        Issue/Submission Date
        2005-08-31
        2021-08-03
        2022-06-20
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        UQUIFA

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        Application Number
        21103
        Status
        Active
        Fees Paid
        N/A
         
        Filing Details
        Bicalutamide
        Issue/Submission Date
        2007-11-30
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        Hetero Drugs

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        Application Number
        18496
        R1-CEP 2012-254 - Rev 02
        226MF10046
        Indian CDSCO WC-0041
        Status
        Active
        Fees Paid
        N/A
        Valid
         
        Valid
        2025-08-08
        Filing Details
        BICALUTAMIDE (FORM-H1)
        Bicalutamide, Form-H1
        Bicalutamide "BT" at 7-2-A2,Hetero ...
        Bicalutamide (USP & Ph Eur)
        Issue/Submission Date
        2005-07-07
        2023-01-09
        2014-02-20
        2022-09-16
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        Sun Pharmaceutical Industries Limit...

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        Bicalutamide

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        Found JDMF

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        Application Number
        20263
        226MF10195
        Indian CDSCO WC-0159
        Status
        Active
        Fees Paid
        N/A
         
        Valid
        2025-07-25
        Filing Details
        BICALUTAMIDE USP
        Bicalutamide at SUN HOUSE, Plot No....
        Bicalutamide (USP)
        Issue/Submission Date
        2007-02-10
        2014-10-27
        2022-06-08
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        Mac-Chem Products (India) Pvt.Ltd

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        Application Number
        26355
        R0-CEP 2019-329 - Rev 00
        Indian CDSCO WC-0275
        Status
        Active
        Fees Unpaid
        N/A
        Suspended by EDQM GMP non-compliance
         
        Expired
        2023-08-01
        Filing Details
        BICALUTAMIDE USP
        Bicalutamide
        Bicalutamide USP/IP
        Issue/Submission Date
        2012-08-27
        2021-06-11
        2021-01-22
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        Teva API

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        Application Number
        17008
        R1-CEP 2012-303 - Rev 01
        Status
        Active
        Fees Paid
        N/A
        Valid
         
        Filing Details
        BICALUTAMIDE
        Bicalutamide
        Issue/Submission Date
        2003-12-05
        2021-11-23
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        MSN Laboratories

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        Application Number
        25730
        R1-CEP 2012-283 - Rev 01
        Indian CDSCO WC-0349
        Status
        Active
        Fees Paid
        N/A
        Valid
         
        Valid
        2025-05-05
        Filing Details
        BICALUTAMIDE USP [ROUTE CODE - "BL"...
        Bicalutamide
        Bicalutamide (Ph.Eur/USP)
        Issue/Submission Date
        2012-01-24
        2023-08-10
        2022-09-02
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        Zhejiang Hisun Pharmaceutical

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        Application Number
        17878
        R0-CEP 2013-195 - Rev 00
        Status
        Active
        Fees Paid
        Reviewed
        Withdrawn by Holder
         
        Filing Details
        BICALUTAMIDE USP
        Bicalutamide
        Issue/Submission Date
        2004-12-03
        2014-09-19
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        Olon S.p.A

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        Application Number
        19624
        219MF10221
        Status
        Active
        Fees Paid
        N/A
         
        Filing Details
        BICALUTAMIDE DRUG SUBSTANCE
        Bicalutamide at Strada Rivoltana, k...
        Issue/Submission Date
        2006-07-10
        2007-07-06
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        COSMA S.p.A

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        Application Number
        19410
        Status
        Inactive
        Fees Paid
        N/A
         
        Filing Details
        BICALUTAMIDE
        Issue/Submission Date
        2006-04-21
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        Gedeon Richter

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          Bicalutamide

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          Application Number
          18776
          Status
          Inactive
          Fees Unpaid
          N/A
           
          Filing Details
          BICALUTAMIDE (MICRONIZED)
          Issue/Submission Date
          2005-09-15
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          Apotex Pharmachem

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          Bicalutamide

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          Application Number
          22784
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          BICALUTAMIDE USP
          Issue/Submission Date
          2009-05-15
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          Tai Heng Industry Co., Ltd

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          Application Number
          19546
          Status
          Inactive
          Fees Unpaid
          N/A
           
          Filing Details
          BICALUTAMIDE
          Issue/Submission Date
          2006-04-30
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          Lupin Ltd

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          Application Number
          19587
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          BICALUTAMIDE
          Issue/Submission Date
          2006-06-30
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          Emcure Pharmaceuticals

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          Application Number
          24922
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          BICALUTAMIDE USP
          Issue/Submission Date
          2011-06-08
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          Kekule Pharma

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          Bicalutamide

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          USDMF

          Caution USDMF

          CEP/COS

          Found CEP/COS

          Japanese DMF

          Found JDMF

          Written Confirmation

          Caution WC

          Application Number
          20785
          R1-CEP 2012-413 - Rev 00
          221MF10073
          Indian CDSCO WC-0194A1
          Status
          Inactive
          Fees Paid
          N/A
          Valid
           
          Expired
          2022-07-02
          Filing Details
          BICALUTAMIDE
          Bicalutamide
          Bicalutamide at A-4, Madhura Nagar,...
          Bicalutamide EP
          Issue/Submission Date
          2007-08-01
          2019-07-10
          2009-04-14
          2020-06-18
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          GENESEN LABS LTD

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            USDMF

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            Application Number
            21333
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            BICALUTAMIDE
            Issue/Submission Date
            2007-09-03
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            Arevipharma

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            Application Number
            21670
            Status
            Inactive
            Fees Paid
            N/A
             
            Filing Details
            BICALUTAMIDE
            Issue/Submission Date
            2008-05-13
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            Sumitomo Chemical

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            Application Number
            19311
            222MF10219
            Status
            Inactive
            Fees Paid
            N/A
             
            Filing Details
            BICALUTAMIDE DRUG SUBSTANCE
            Bicalutamide at 2-7-1 Nihonbashi, C...
            Issue/Submission Date
            2006-03-31
            2010-08-10
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            Fresenius Kabi AB Brunna

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            Application Number
            20099
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            BICALUTAMIDE
            Issue/Submission Date
            2006-12-28
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            Fresenius Kabi Oncology Limited

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            Application Number
            R1-CEP 2012-369 - Rev 00
            Indian CDSCO WC-0115
            Status
            Valid
             
            Expired
            2022-07-07
            Filing Details
            Bicalutamide
            Bicalutamide (USP/IH)
            Issue/Submission Date
            2021-05-20
            2019-07-08
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            Shaanxi Dasheng

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              Application Number
              CEP 2017-174 - Rev 02
              303MF10037
              Status
              Valid
               
              Filing Details
              Bicalutamide
              Bicalutamide at F9 of Jiezuo Square...
              Issue/Submission Date
              2023-11-17
              2021-02-19
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              Looking for 90357-06-5 / Bicalutamide API manufacturers, exporters & distributors?

              Bicalutamide manufacturers, exporters & distributors 1

              76

              PharmaCompass offers a list of Bicalutamide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Bicalutamide manufacturer or Bicalutamide supplier for your needs.

              Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bicalutamide manufacturer or Bicalutamide supplier.

              PharmaCompass also assists you with knowing the Bicalutamide API Price utilized in the formulation of products. Bicalutamide API Price is not always fixed or binding as the Bicalutamide Price is obtained through a variety of data sources. The Bicalutamide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

              API | Excipient name

              Bicalutamide

              Synonyms

              90357-06-5, Casodex, Bicalutamide (cdx), Calutide, Ici 176334, Ici-176334

              Cas Number

              90357-06-5

              Unique Ingredient Identifier (UNII)

              A0Z3NAU9DP

              About Bicalutamide

              Bicalutamide is a synthetic, nonsteroidal antiandrogen. Bicalutamide competitively binds to cytosolic androgen receptors in target tissues, thereby inhibiting the receptor binding of androgens. This agent does not bind to most mutated forms of androgen receptors. (NCI04)

              Bicalutamide Manufacturers

              A Bicalutamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bicalutamide, including repackagers and relabelers. The FDA regulates Bicalutamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bicalutamide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

              click here to find a list of Bicalutamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

              Bicalutamide Suppliers

              A Bicalutamide supplier is an individual or a company that provides Bicalutamide active pharmaceutical ingredient (API) or Bicalutamide finished formulations upon request. The Bicalutamide suppliers may include Bicalutamide API manufacturers, exporters, distributors and traders.

              click here to find a list of Bicalutamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

              Bicalutamide Manufacturers | Traders | Suppliers

              Bicalutamide Manufacturers, Traders, Suppliers 1
              18

              We have 44 companies offering Bicalutamide

              Get in contact with the supplier of your choice:

              1. Fareva
              2. Aarti Pharmalabs
              3. Zeon Pharma Industries India Pvt Ltd
              4. CF Pharma
              5. LGM Pharma
              6. HRV Global Life Sciences
              7. USV Private Limited
              8. Apotex Pharmachem
              9. Arevipharma
              10. Aspen Biopharma Labs
              11. Bo-Chem Pvt Ltd
              12. Cipla
              13. COSMA S.p.A
              14. Emcure Pharmaceuticals
              15. Fresenius Kabi AB Brunna
              16. Fresenius Kabi Oncology Limited
              17. Gedeon Richter
              18. GENESEN LABS LTD
              19. Guangzhou Tosun Pharmaceutical
              20. Hetero Drugs
              21. Kekule Pharma
              22. Lupin Ltd
              23. Mac-Chem Products (India) Pvt.Ltd
              24. MSN Laboratories
              25. NEWEDGE Overseas
              26. Nishchem International Pvt. Ltd
              27. Olon S.p.A
              28. Sakar Healthcare
              29. Shaanxi Dasheng
              30. Shandong Haohong Biotechnology Co.,ltd
              31. Shilpa Medicare
              32. Stason Pharmaceuticals, Inc.
              33. Sumar Biotech
              34. Sumitomo Chemical
              35. Sun Pharmaceutical Industries Limited
              36. Synthon Pharmaceuticals
              37. Tai Heng Industry Co., Ltd
              38. Teva API
              39. Teva Pharmaceutical Industries
              40. Unipex
              41. UQUIFA
              42. Vannsh Life Sciences
              43. Viatris
              44. Zhejiang Hisun Pharmaceutical
              Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
              For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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