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    Irbesartan

    APIs // Active Pharmaceutical Ingredients

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    EUROAPI

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    Application Number
    19690
    R0-CEP 2020-101 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    IRBESARTAN DRUG SUBSTANCE
    Irbesartan, CHINOIN
    Issue/Submission Date
    2006-08-15
    2021-12-16
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    Tenatra Chemie

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    Jai Radhe Sales

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      Octavius Pharma Pvt. Ltd

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        Zeon Pharma Industries India Pvt Lt...

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          Sanofi

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          Application Number
          10310
          CEP 2017-160 - Rev 01
          225MF10180
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          Filing Details
          IRBESARTAN DRUG SUBSTANCE
          Irbesartan
          Irbesartan at 82 Avenue Raspail 942...
          Issue/Submission Date
          1993-06-30
          2024-02-14
          2013-09-18
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          LGM Pharma

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          HRV Global Life Sciences

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            Sigmak Lifesciences

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              USV Private Limited

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              Application Number
              Indian CDSCO WC-0012
              Status
               
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              2025-06-02
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              Irbesartan Ph. EurllH/USP
              Issue/Submission Date
              2022-06-27
              USV Private Limited

              CPhI Worldwide, Milan

              Booth #10F41

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              Cipla

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              Application Number
              20176
              Status
              Inactive
              Fees Paid
              N/A
               
              Filing Details
              IRBESARTAN
              Issue/Submission Date
              2008-12-03
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              Alembic Pharmaceuticals Limited

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              Application Number
              20378
              R1-CEP 2011-153 - Rev 04
              Indian CDSCO WC-0083
              Status
              Active
              Fees Paid
              N/A
              Valid
               
              Valid
              2025-07-02
              Filing Details
              IRBESARTAN USP
              Irbesartan
              Irbesartan EP
              Issue/Submission Date
              2007-03-19
              2023-03-16
              2022-06-03
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              Ajinomoto Company

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              Application Number
              12870
              Status
              Inactive
              Fees Paid
              N/A
               
              Filing Details
              IRBESARTAN CRUDE
              Issue/Submission Date
              1998-02-20
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              Lupin Ltd

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              Application Number
              20198
              228MF10172
              Status
              Inactive
              Fees Paid
              N/A
               
              Filing Details
              IRBESARTAN USP
              Irbesartan at Kalpataru Inspire, 3r...
              Issue/Submission Date
              2007-01-19
              2016-08-29
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              Lupin Ltd

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              Application Number
              23398
              Status
              Inactive
              Fees Paid
              N/A
               
              Filing Details
              IRBESARTAN USP (PROCESS B)
              Issue/Submission Date
              2010-03-12
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              Zhejiang Apeloa Jiayuan Pharmaceuti...

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              Application Number
              24752
              Status
              Active
              Fees Paid
              Reviewed
               
              Filing Details
              IRBESARTAN API
              Issue/Submission Date
              2011-03-08
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              Zhuhai Rundu Pharmaceutical

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                Application Number
                25509
                301MF10035
                Status
                Inactive
                Fees Unpaid
                N/A
                 
                Filing Details
                IRBESARTAN
                Irbesartan at No. 6, North Airport ...
                Issue/Submission Date
                2011-11-14
                2019-07-31
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                  Application Number
                  32803
                  Status
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                  Fees Unpaid
                  Reviewed
                   
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                  IRBESARTAN, NON-STERILE BULK DRUG S...
                  Issue/Submission Date
                  2019-11-12
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                  Macleods Pharmaceuticals Limited

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                  Application Number
                  23449
                  CEP 2011-046 - Rev 05
                  Indian CDSCO WC-0079A2
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                  N/A
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                  Expired
                  2022-07-02
                  Filing Details
                  IRBESARTAN
                  Irbesartan
                  Irbesartan EP/USP
                  Issue/Submission Date
                  2010-01-11
                  2023-11-07
                  2021-04-09
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                  Hetero Drugs

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                  Application Number
                  17507
                  CEP 2017-104 - Rev 04
                  228MF10007
                  Indian CDSCO WC-0041
                  Status
                  Active
                  Fees Paid
                  Reviewed
                  Valid
                   
                  Valid
                  2025-08-08
                  Filing Details
                  IRBESARTAN (FORM A) PROCESS I
                  Irbesartan
                  Irbesartan at 7-2-A2,Hetero Corpora...
                  Irbesartan (USP/Ph. Eur)
                  Issue/Submission Date
                  2004-07-02
                  2024-03-25
                  2016-01-08
                  2022-09-16
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                  Hetero Drugs

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                  Application Number
                  24665
                  Status
                  Inactive
                  Fees Paid
                  N/A
                   
                  Filing Details
                  IRBESARTAN (FORM A) PROCESS II
                  Issue/Submission Date
                  2011-02-23
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                  Calyx Chemicals & Pharmaceuticals L...

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                  Application Number
                  24017
                  Status
                  Active
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                  N/A
                   
                  Filing Details
                  IRBESARTAN
                  Issue/Submission Date
                  2010-07-26
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                  ULKAR KIMYA SANAYII VE TICARET

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                  Application Number
                  25861
                  R0-CEP 2012-156 - Rev 00
                  Status
                  Active
                  Fees Unpaid
                  N/A
                  Expired
                   
                  Filing Details
                  IRBESARTAN USP
                  Irbesartan
                  Issue/Submission Date
                  2012-03-07
                  2015-05-21
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                  Unichem Laboratories Limited

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                  Application Number
                  23835
                  R1-CEP 2011-151 - Rev 02
                  Indian CDSCO WC-0062A3
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                  Expired
                  2022-07-21
                  Filing Details
                  IRBESARTAN USP
                  Irbesartan
                  Irbesartan EP
                  Issue/Submission Date
                  2010-06-04
                  2022-03-01
                  2019-10-03
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                  Quimica Sintetica S.A.

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                  Application Number
                  18746
                  Status
                  Inactive
                  Fees Paid
                  N/A
                   
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                  IRBESARTAN
                  Issue/Submission Date
                  2005-09-08
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                  Zhejiang Huahai Pharmaceutical

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                  Application Number
                  21754
                  R1-CEP 2010-033 - Rev 03
                  228MF10003
                  Status
                  Inactive
                  Fees Paid
                  N/A
                  Valid
                   
                  Filing Details
                  IRBESARTAN
                  Irbesartan
                  Irbesartan at Xunqiao, Linhai, Zhej...
                  Issue/Submission Date
                  2008-06-27
                  2021-05-05
                  2016-01-08
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                  Zhejiang Huahai Pharmaceutical

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                  Application Number
                  21780
                  Status
                  Active
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                  IRBESARTAN USP
                  Issue/Submission Date
                  2008-05-28
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                  HEC Pharm

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                  Application Number
                  26802
                  Status
                  Inactive
                  Fees Paid
                  N/A
                   
                  Filing Details
                  IRBESARTAN NON-STERILE BULK DRUG SU...
                  Issue/Submission Date
                  2013-01-05
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                  Bristol Myers Squibb

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                  Application Number
                  12882
                  Status
                  Inactive
                  Fees Unpaid
                  N/A
                   
                  Filing Details
                  IRBESARTAN
                  Issue/Submission Date
                  1998-02-27
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                  Bristol Myers Squibb

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                  Application Number
                  13265
                  Status
                  Inactive
                  Fees Unpaid
                  N/A
                   
                  Filing Details
                  IRBESARTAN
                  Issue/Submission Date
                  1998-10-08
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                  Piramal Pharma Solutions

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                  Application Number
                  26684
                  Status
                  Active
                  Fees Paid
                  N/A
                   
                  Filing Details
                  IRBESARTAN
                  Issue/Submission Date
                  2012-12-04
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                  Siegfried AG

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                  Application Number
                  15406
                  Status
                  Inactive
                  Fees Paid
                  N/A
                   
                  Filing Details
                  IRBESARTAN(SR47436)
                  Issue/Submission Date
                  2001-04-26
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                  Teva API

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                  Application Number
                  17394
                  CEP 2022-046 - Rev 01
                  Indian CDSCO WC-0001
                  Status
                  Active
                  Fees Paid
                  N/A
                  Valid
                   
                  Valid
                  2025-05-20
                  Filing Details
                  IRBESARTAN
                  Irbesartan, Process 2
                  Irbesartan EP
                  Issue/Submission Date
                  2004-05-18
                  2024-03-04
                  2022-06-22
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                  Teva API

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                  Application Number
                  25483
                  R1-CEP 2010-322 - Rev 02
                  Indian CDSCO WC-0002
                  Status
                  Active
                  Fees Paid
                  Reviewed
                  Valid
                   
                  Expired
                  2022-05-26
                  Filing Details
                  IRBESARTAN USP
                  Irbesartan
                  Irbessartan (IH/USP/EP)
                  Issue/Submission Date
                  2011-11-08
                  2022-03-07
                  2019-06-17
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                  Aurobindo Pharma Limited

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                  Application Number
                  23084
                  CEP 2021-297 - Rev 01
                  228MF10097
                  Indian CDSCO WC-0120
                  Status
                  Active
                  Fees Paid
                  Reviewed
                  Valid
                   
                  Valid
                  2025-07-02
                  Filing Details
                  IRBESARTAN USP (NON-STERILE DRUG SU...
                  Irbesartan, Process II
                  Japanese Pharmacopoeia irbesartan a...
                  Irbesartan Ph.Eur
                  Issue/Submission Date
                  2009-08-31
                  2023-12-13
                  2016-05-16
                  2022-07-15
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                  MSN Laboratories

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                  Application Number
                  36068
                  R0-CEP 2021-351 - Rev 00
                  Status
                  Active
                  Fees Paid
                  Reviewed
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                  Filing Details
                  IRBESARTAN USP
                  Irbesartan
                  Issue/Submission Date
                  2021-07-31
                  2023-01-18
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                  Dynamit Nobel GmbH Explosivstoff- u...

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                  Application Number
                  13004
                  Status
                  Inactive
                  Fees Paid
                  N/A
                   
                  Filing Details
                  SR 47436 (CRUDE)
                  Issue/Submission Date
                  1998-05-27
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                  Jubilant Generics

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                  Application Number
                  19790
                  CEP 2011-087 - Rev 04
                  Status
                  Active
                  Fees Paid
                  Reviewed
                  Valid
                   
                  Filing Details
                  IRBESARTAN USP
                  Irbesartan
                  Issue/Submission Date
                  2006-09-14
                  2024-03-25
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                  Viatris

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                  Application Number
                  17912
                  R1-CEP 2010-124 - Rev 07
                  228MF10138
                  Indian CDSCO WC-0117
                  Status
                  Active
                  Fees Paid
                  N/A
                  Valid
                   
                  Valid
                  2025-07-28
                  Filing Details
                  IRBESARTAN USP
                  Irbesartan
                  Japanese Pharmacopoeia irbesartan a...
                  Irbesartan USP/Ph.Eur
                  Issue/Submission Date
                  2004-12-20
                  2023-04-26
                  2016-07-27
                  2022-06-22
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                  Zydus Lifesciences

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                  Application Number
                  20361
                  Indian CDSCO WC-0084
                  Status
                  Active
                  Fees Paid
                  N/A
                   
                  Expired
                  2022-07-14
                  Filing Details
                  IRBESARTAN USP
                  Itbesartan IH
                  Issue/Submission Date
                  2007-03-22
                  2019-07-15
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                  Divis Laboratories

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                  Application Number
                  26418
                  R1-CEP 2012-339 - Rev 03
                  Indian CDSCO WC-0030
                  Status
                  Active
                  Fees Paid
                  Reviewed
                  Valid
                   
                  Expired
                  2022-06-16
                  Filing Details
                  IRBESARTAN USP
                  Irbesartan
                  Irbesartan (USP/Ph. Eur)
                  Issue/Submission Date
                  2012-09-11
                  2021-11-08
                  2019-06-17
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                  Zydus Lifesciences

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                  Application Number
                  25446
                  Status
                  Inactive
                  Fees Paid
                  N/A
                   
                  Filing Details
                  IRBESARTAN USP
                  Issue/Submission Date
                  2011-11-12
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                  Signa S.A. de C.V.

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                  Application Number
                  23347
                  R1-CEP 2010-327 - Rev 03
                  Status
                  Inactive
                  Fees Paid
                  N/A
                  Withdrawn by Holder
                   
                  Filing Details
                  IRBESARTAN USP
                  Irbesartan
                  Issue/Submission Date
                  2009-12-07
                  2020-01-08
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                  Cadila Pharmaceuticals

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                  Application Number
                  21369
                  Status
                  Inactive
                  Fees Paid
                  N/A
                   
                  Filing Details
                  IRBESARTAN (POLYMORPHIC FORM-A)
                  Issue/Submission Date
                  2007-12-31
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                  RANBAXY LABORATORIES LIMITED

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                  Application Number
                  17796
                  Status
                  Inactive
                  Fees Paid
                  N/A
                   
                  Filing Details
                  IRBESARTAN USP
                  Issue/Submission Date
                  2004-10-29
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                  CTX Lifesciences

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                  Application Number
                  24596
                  R1-CEP 2011-139 - Rev 05
                  Indian CDSCO WC-0097
                  Status
                  Active
                  Fees Paid
                  Reviewed
                  Valid
                   
                  Valid
                  2025-07-02
                  Filing Details
                  IRBESARTAN USP
                  Irbesartan
                  Irbesartan(Ph. Eur.)
                  Issue/Submission Date
                  2011-04-19
                  2023-06-16
                  2022-06-24
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                  Micro Labs Limited

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                  Application Number
                  24834
                  CEP 2020-260 - Rev 03
                  Indian CDSCO WC-0225
                  Status
                  Active
                  Fees Paid
                  Reviewed
                  Valid
                   
                  Expired
                  2022-08-15
                  Filing Details
                  IRBESARTAN USP
                  Irbesartan, Process II
                  Irbesartan (Ph. Eur/USP)
                  Issue/Submission Date
                  2011-03-28
                  2023-12-14
                  2019-08-16
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                  Sun Pharmaceutical Industries Limit...

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                  Application Number
                  R1-CEP 2010-195 - Rev 08
                  Indian CDSCO WC-0011
                  Status
                  Valid
                   
                  Valid
                  2025-06-02
                  Filing Details
                  Irbesartan
                  Irbesartan (USP/Ph.Eur.)
                  Issue/Submission Date
                  2023-04-28
                  2022-06-08
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                  Viatris

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                  Application Number
                  R0-CEP 2021-100 - Rev 02
                  Indian CDSCO WC-0117A2
                  Status
                  Valid
                   
                  Expired
                  2022-07-28
                  Filing Details
                  Irbesartan, Process II
                  Irbesartan EP/USP
                  Issue/Submission Date
                  2023-04-28
                  2019-08-13
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                  Zhejiang Tianyu Pharmaceutical Co.,...

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                  Application Number
                  R1-CEP 2012-233 - Rev 02
                  304MF10158
                  Status
                  Valid
                   
                  Filing Details
                  Irbesartan
                  Irbesartan at Jiangkou Development...
                  Issue/Submission Date
                  2021-07-23
                  2022-12-23
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                  Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
                  left grey arrow
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                  • TABLET;ORAL - 150MG
                  • TABLET;ORAL - 300MG
                  • TABLET;ORAL - 75MG
                  • TABLET;ORAL - 12.5MG;150MG
                  • TABLET;ORAL - 12.5MG;300MG
                  • TABLET;ORAL - 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
                  • TABLET;ORAL - 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

                  Looking for 138402-11-6 / Irbesartan API manufacturers, exporters & distributors?

                  Irbesartan manufacturers, exporters & distributors 1

                  89

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

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

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

                  API | Excipient name

                  Irbesartan

                  Synonyms

                  138402-11-6, Avapro, Aprovel, Karvea, Sr-47436, Bms-186295

                  Cas Number

                  138402-11-6

                  Unique Ingredient Identifier (UNII)

                  J0E2756Z7N

                  About Irbesartan

                  A spiro compound, biphenyl and tetrazole derivative that acts as an angiotensin II type 1 receptor antagonist. It is used in the management of HYPERTENSION, and in the treatment of kidney disease.

                  Irbesartan Manufacturers

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

                  Irbesartan Suppliers

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

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

                  Irbesartan Manufacturers | Traders | Suppliers

                  Irbesartan Manufacturers, Traders, Suppliers 1
                  53

                  We have 69 companies offering Irbesartan

                  Get in contact with the supplier of your choice:

                  1. EUROAPI
                  2. Tenatra Chemie
                  3. Jai Radhe Sales
                  4. Octavius Pharma Pvt. Ltd
                  5. Zeon Pharma Industries India Pvt Ltd
                  6. Sanofi
                  7. LGM Pharma
                  8. HRV Global Life Sciences
                  9. Sigmak Lifesciences
                  10. USV Private Limited
                  11. Active Pharma
                  12. Ajinomoto Company
                  13. Alembic Pharmaceuticals Limited
                  14. Amara Labs
                  15. Anwita Drugs & Chemicals Pvt Ltd
                  16. Aspire Lifesciences Pvt Ltd
                  17. Aurobindo Pharma Limited
                  18. Bal Pharma
                  19. Bristol Myers Squibb
                  20. Cadila Pharmaceuticals
                  21. Calyx Chemicals & Pharmaceuticals Limited
                  22. CHEMO
                  23. Cipla
                  24. CTX Lifesciences
                  25. Daito Pharmaceutical Co.,Ltd.
                  26. Divis Laboratories
                  27. Dynamit Nobel GmbH Explosivstoff- und Systemtechnik
                  28. Freemen Nutra
                  29. Guangzhou Topwork Chemical
                  30. Guangzhou Tosun Pharmaceutical
                  31. Hanmi Pharmaceutical
                  32. HEC Pharm
                  33. Hetero Drugs
                  34. Hoventa Pharma
                  35. Jubilant Generics
                  36. Jubilant Pharmova
                  37. Laurus Labs
                  38. Lupin Ltd
                  39. Macleods Pharmaceuticals Limited
                  40. Micro Labs Limited
                  41. MSN Laboratories
                  42. Nanjing Dorra Pharmaceutical Technology Co.,Ltd
                  43. Otto Brandes
                  44. Piramal Pharma Solutions
                  45. Quimica Sintetica S.A.
                  46. RANBAXY LABORATORIES LIMITED
                  47. Shin Poong Pharm Co Ltd
                  48. Sibbiotech
                  49. Siegfried AG
                  50. Signa S.A. de C.V.
                  51. Smilax Laboratories Limited
                  52. Sun Pharmaceutical Industries Limited
                  53. Suvan Lifesciences
                  54. Synergene Active Ingredients Pvt Ltd
                  55. Tecoland Corporation
                  56. Teva API
                  57. Teva Pharmaceutical Industries
                  58. Titan Laboratories
                  59. ULKAR KIMYA SANAYII VE TICARET
                  60. Unichem Laboratories Limited
                  61. Verdant Life Sciences
                  62. Viatris
                  63. Zhejiang Apeloa Jiayuan Pharmaceutical
                  64. Zhejiang Apeloa Tospo Pharmaceutical Co. Ltd
                  65. Zhejiang Huahai Pharmaceutical
                  66. Zhejiang Kinglyuan Pharmaceutical
                  67. Zhejiang Tianyu Pharmaceutical Co., Ltd
                  68. Zhuhai Rundu Pharmaceutical
                  69. Zydus Lifesciences
                  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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                  veranova-m-2024-04-22

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