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

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    Leuprolide Acetate

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    01 Bachem AG (1)

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    Bachem AG

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    • FDA
    • EDQM
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    Virtual BoothBachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
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    Leuprolide Acetate

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    Application Number
    13822
    R1-CEP 2001-454 - Rev 01
    222MF10137
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LEUPROLIDE ACETATE
    Leuprorelin
    Leuprorelin acetate at Hauptstrasse...
    Issue/Submission Date
    1998-11-06
    2009-02-18
    2010-04-14
    Bachem company banner

    CPhI Japan

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    Aspen API

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    Application Number
    28808
    R1-CEP 2016-199 - Rev 00
    224MF10165
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LEUPRORELIN HIGHLY PURIFIED
    Leuprorelin
    Leuprorelin acetate at Kloosterstra...
    Issue/Submission Date
    2014-11-06
    2022-08-26
    2012-08-16
    Aspen API Comapny Banner

    CPhI Japan

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    Sanofi

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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    Leuprolide Acetate

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    Application Number
    14440
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    LEUPROLIDE ACETATE
    Issue/Submission Date
    1999-10-08
    Sanofi Company Banner

    CPhI Japan

    Not Confirmed

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    HRV Global Life Sciences

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      Leuprolide Acetate

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      HRV Global Life Sciences Company Banner

      CPhI Japan

      Not Confirmed

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      Aspen API

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      Leuprolide Acetate

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      Application Number
      R0-CEP 2021-472 - Rev 00
      Status
      Valid
       
      Filing Details
      Leuprorelin, NR
      Issue/Submission Date
      2022-02-28
      Aspen API Comapny Banner

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      ReaLi Tide Biological Technology

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        Leuprolide Acetate

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        Application Number
        33765
        Status
        Active
        Fees Unpaid
        N/A
         
        Filing Details
        LEUPROLIDE ACETATE
        Issue/Submission Date
        2019-08-27
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        Anygen

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          Application Number
          25878
          Status
          Active
          Fees Unpaid
          N/A
           
          Filing Details
          LEUPRORELIN ACETATE
          Issue/Submission Date
          2011-12-12
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          Zhejiang Peptites Biotech Co.,Ltd

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            Application Number
            35071
            R0-CEP 2020-305 - Rev 00
            Status
            Active
            Fees Unpaid
            N/A
            Valid
             
            Filing Details
            LEUPROLIDE ACETATE
            Leuprorelin
            Issue/Submission Date
            2020-09-14
            2022-03-04
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            PolyPeptide Group

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            Application Number
            13150
            R1-CEP 2003-045 - Rev 00
            231MF10082
            Indian CDSCO WC-0047a3
            Status
            Active
            Fees Paid
            N/A
            Valid
             
            Expired
            2022-06-27
            Filing Details
            LEUPROLIDE
            Leuprorelin
            Leuprorelin Acetate at Ho(¨)geruds...
            Leuprolide Acetate USP/EP
            Issue/Submission Date
            1998-08-21
            2009-02-13
            2019-04-03
            2020-01-28
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            PolyPeptide Group

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            Leuprolide Acetate

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            Application Number
            26832
            R1-CEP 2011-321 - Rev 02
            Status
            Active
            Fees Paid
            Reviewed
            Valid
             
            Filing Details
            LEUPROLIDE ACETATE
            Leuprorelin, Process F
            Issue/Submission Date
            2013-02-20
            2023-01-26
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            Sun Pharmaceutical Industries Limit...

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            Leuprolide Acetate

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            Application Number
            27832
            R1-CEP 2014-278 - Rev 00
            Indian CDSCO WC-0159
            Status
            Active
            Fees Paid
            Reviewed
            Valid
             
            Valid
            2025-07-25
            Filing Details
            LEUPROLIDE ACETATE USP
            Leuprorelin
            Leuprolide Acetate (USP)
            Issue/Submission Date
            2014-01-24
            2021-02-26
            2022-06-08
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            ALP Pharm

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              Application Number
              34847
              Status
              Active
              Fees Unpaid
              N/A
               
              Filing Details
              LEUPROLIDE ACETATE
              Issue/Submission Date
              2020-04-28
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              Auro Peptides Limited

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                Application Number
                31170
                Indian CDSCO WC-0443-A1-2
                Status
                Active
                Fees Unpaid
                Reviewed
                 
                Expired
                2019-07-22
                Filing Details
                LEUPROLIDE ACETATE USP
                Leuprolide Acetate IH
                Issue/Submission Date
                2016-11-30
                2022-06-10
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                Chemi SpA

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                Leuprolide Acetate

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                Application Number
                14763
                R1-CEP 2008-115 - Rev 04
                224MF10177
                Status
                Active
                Fees Paid
                Reviewed
                Valid
                 
                Filing Details
                LEUPROLIDE ACETATE
                Leuprorelin
                Leuprorelin acetate at Via dei Labo...
                Issue/Submission Date
                2000-03-07
                2022-03-10
                2012-08-17
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                Takeda Pharmaceutical

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                Leuprolide Acetate

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                Application Number
                9365
                Status
                Active
                Fees Unpaid
                N/A
                 
                Filing Details
                TAP-144-SR (3M) (22.5MG.)
                Issue/Submission Date
                1991-09-30
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                Takeda Pharmaceutical

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                Leuprolide Acetate

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                Application Number
                10416
                Status
                Active
                Fees Unpaid
                N/A
                 
                Filing Details
                LEUPROLIDE ACETATE
                Issue/Submission Date
                1993-08-13
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                Takeda Pharmaceutical

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                Application Number
                11395
                Status
                Active
                Fees Unpaid
                N/A
                 
                Filing Details
                TAP-144-SR (1M)
                Issue/Submission Date
                1995-03-24
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                Piramal Pharma Solutions

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                Application Number
                25128
                Indian CDSCO WC-0237
                Status
                Active
                Fees Paid
                N/A
                 
                Expired
                2022-09-02
                Filing Details
                LEUPROLIDE ACETATE
                Leuproreline BP/EP
                Issue/Submission Date
                2011-06-30
                2019-09-03
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                BCN Peptides

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                Application Number
                26716
                R1-CEP 2000-078 - Rev 04
                302MF10043
                Status
                Active
                Fees Paid
                Reviewed
                Valid
                 
                Filing Details
                LEUPROLIDE (LEUPRORELIN)
                Leuprorelin, sterile
                Leuprorelin Acetate at Poligono ind...
                Issue/Submission Date
                2012-12-11
                2017-04-19
                2020-04-02
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                Chinese Peptide Company

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                Application Number
                29355
                Status
                Inactive
                Fees Unpaid
                N/A
                 
                Filing Details
                LEUPROLIDE ACETATE
                Issue/Submission Date
                2015-04-29
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                AmbioPharm

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                Application Number
                26380
                Status
                Inactive
                Fees Paid
                N/A
                 
                Filing Details
                LEUPROLIDE, NON-STERILE, BULK DRUG ...
                Issue/Submission Date
                2012-09-05
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                Mallinckrodt Pharmaceuticals

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                Application Number
                12052
                R1-CEP 2001-323 - Rev 02
                Status
                Inactive
                Fees Paid
                N/A
                Withdrawn by Holder
                 
                Filing Details
                LEUPROLIDE ACETATE
                Leuprorelin
                Issue/Submission Date
                1996-07-18
                2012-07-20
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                Mallinckrodt Pharmaceuticals

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                Application Number
                24845
                Status
                Inactive
                Fees Paid
                N/A
                 
                Filing Details
                LEUPROLIDE ACETATE (SPECIAL)
                Issue/Submission Date
                2013-05-29
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                Teva API

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                Application Number
                15189
                R1-CEP 2006-028 - Rev 01
                Status
                Inactive
                Fees Paid
                N/A
                Withdrawn by Holder
                 
                Filing Details
                LEUPROLIDE ACETATE
                Leuprorelin
                Issue/Submission Date
                2000-12-11
                2015-07-15
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                Takeda Pharmaceutical

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                Application Number
                4476
                R1-CEP 2001-441 - Rev 03
                Status
                Inactive
                Fees Unpaid
                N/A
                Valid
                 
                Filing Details
                TAP-144 LEUPROLIDE BULK PRODUCTION ...
                Leuprorelin
                Issue/Submission Date
                1982-01-25
                2022-07-29
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                Takeda Pharmaceutical

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                Leuprolide Acetate

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                USDMF

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                Application Number
                6142
                Status
                Inactive
                Fees Unpaid
                N/A
                 
                Filing Details
                TAP-144-SR INJECTION (EXTENDED-RELE...
                Issue/Submission Date
                1985-12-23
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                Takeda Pharmaceutical

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                Application Number
                7021
                Status
                Inactive
                Fees Unpaid
                N/A
                 
                Filing Details
                LUPRON DEPOT AND LUPRON DEPOT VEHIC...
                Issue/Submission Date
                1987-06-09
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                Peninsula Laboratories

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                  Leuprolide Acetate

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                  Application Number
                  13922
                  Status
                  Inactive
                  Fees Unpaid
                  N/A
                   
                  Filing Details
                  LEUPROLIDE
                  Issue/Submission Date
                  1998-12-29
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                  Application Number
                  15164
                  Status
                  Inactive
                  Fees Unpaid
                  N/A
                   
                  Filing Details
                  LEUPROLIDE ACETATE NON-STERILE BULK...
                  Issue/Submission Date
                  2000-11-27
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                  Application Number
                  CEP 2011-274 - Rev 02
                  Status
                  Valid
                   
                  Filing Details
                  Leuprorelin
                  Issue/Submission Date
                  2024-03-04
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                  Looking for 74381-53-6 / Leuprolide Acetate API manufacturers, exporters & distributors?

                  Leuprolide Acetate manufacturers, exporters & distributors 1

                  34

                  PharmaCompass offers a list of Leuprolide Acetate 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 Leuprolide Acetate manufacturer or Leuprolide Acetate supplier for your needs.

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

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

                  API | Excipient name

                  Leuprolide Acetate

                  Synonyms

                  74381-53-6, Leuprorelin acetate;h-pyr-his-trp-ser-tyr-d-leu-leu-arg-pro-nhet.ch3co2h, Lupron (tn), Mfcd00072080, Fensolvi (tn), Eligard (tn)

                  Cas Number

                  74381-53-6

                  Leuprolide Acetate Manufacturers

                  A Leuprolide Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Leuprolide Acetate, including repackagers and relabelers. The FDA regulates Leuprolide Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Leuprolide Acetate 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 Leuprolide Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

                  Leuprolide Acetate Suppliers

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

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

                  Leuprolide Acetate Manufacturers | Traders | Suppliers

                  Leuprolide Acetate Manufacturers, Traders, Suppliers 1
                  82

                  We have 31 companies offering Leuprolide Acetate

                  Get in contact with the supplier of your choice:

                  1. Bachem AG
                  2. Aspen API
                  3. Sanofi
                  4. HRV Global Life Sciences
                  5. ALP Pharm
                  6. AmbioPharm
                  7. ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LTD
                  8. Anygen
                  9. Auro Peptides Limited
                  10. Aurobindo Pharma Limited
                  11. BCN Peptides
                  12. Chemi SpA
                  13. Chinese Peptide Company
                  14. Guangzhou Tosun Pharmaceutical
                  15. Hybio Pharmaceutical
                  16. Jin Dun Medical
                  17. Mallinckrodt Pharmaceuticals
                  18. Omgene Life Sciences
                  19. Peninsula Laboratories
                  20. Piramal Pharma Solutions
                  21. PolyPeptide Group
                  22. ReaLi Tide Biological Technology
                  23. Savior Lifetec Corporation
                  24. ScinoPharm Taiwan, Ltd
                  25. Smaart Pharmaceutticals
                  26. Sun Pharmaceutical Industries Limited
                  27. Takeda Pharmaceutical
                  28. Teva API
                  29. Teva Pharmaceutical Industries
                  30. Viatris
                  31. Zhejiang Peptites Biotech Co.,Ltd
                  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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