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    Biophore India Pharmaceuticals Pvt ...

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    Application Number
    27484
    Status
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    ISOTRETINOIN
    Issue/Submission Date
    2013-09-27
    Biophore

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    LGM Pharma

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    Kimia Biosciences

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      Cophex 2024

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      EASTMAN KODAK

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        Application Number
        4887
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        Fees Unpaid
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        13-Cis-RETINOIC ACID (ISOTRETINOIN)
        Issue/Submission Date
        1983-03-23
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        Hetero Drugs

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        Application Number
        36857
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        ISOTRETINOIN
        Issue/Submission Date
        2022-03-22
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        Sun Pharmaceutical Industries Limit...

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        Application Number
        32517
        R1-CEP 2002-011 - Rev 06
        Indian CDSCO WC-0159
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        Valid
        2025-07-25
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        ISOTRETINOIN USP
        Isotretinoin
        Isotretinoin (USP/EP/BP)
        Issue/Submission Date
        2018-08-31
        2023-05-25
        2022-06-08
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        Ipca Laboratories

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        Application Number
        22616
        R0-CEP 2009-203 - Rev 00
        Status
        Inactive
        Fees Paid
        N/A
        Withdrawn by Holder
         
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        ISOTRETINOIN USP
        Isotretinoin
        Issue/Submission Date
        2009-06-30
        2010-11-26
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        Catalent Pharma Solutions

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        Application Number
        15275
        Status
        Inactive
        Fees Paid
        N/A
         
        Filing Details
        ACCUTANE (10MG, 40MG)
        Issue/Submission Date
        2001-02-02
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        Siegfried AG

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        Application Number
        4676
        R1-CEP 1999-068 - Rev 07
        Status
        Active
        Fees Paid
        Reviewed
        Valid
         
        Filing Details
        13-CIS-RETINOIC ACID (ISOTRETINOIN)
        Isotretinoin
        Issue/Submission Date
        1982-09-27
        2023-03-10
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        JIANGXI HENGXIANG PHARMACEUTICAL TE...

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          Application Number
          19191
          Status
          Active
          Fees Unpaid
          N/A
           
          Filing Details
          ISOTRETINOIN (NON-STERILE BULK FORM...
          Issue/Submission Date
          2005-10-25
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          RANBAXY LABORATORIES LIMITED

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          Application Number
          15169
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          ISOTRETINOIN USP (NON-STERILE BULK)
          Issue/Submission Date
          2000-11-29
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          RP SCHERER GMBH & CO. KG

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            Application Number
            14493
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            ACCUTANE (ISOTRETINOIN)
            Issue/Submission Date
            1999-10-14
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            Olon S.p.A

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            Application Number
            7485
            R1-CEP 1996-082 - Rev 12
            Status
            Active
            Fees Paid
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            Valid
             
            Filing Details
            ISOTRETINOIN
            Isotretinoin
            Issue/Submission Date
            1988-05-16
            2022-04-12
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            BASF

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            Application Number
            13071
            Status
            Inactive
            Fees Paid
            N/A
             
            Filing Details
            9-Z-ISOTRETINOIN
            Issue/Submission Date
            1998-07-01
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            Helsinn Advanced Synthesis

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            Application Number
            19918
            R1-CEP 2004-281 - Rev 01
            Status
            Active
            Fees Paid
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            Valid
             
            Filing Details
            ISOTRETINOIN
            Isotretinoin
            Issue/Submission Date
            2006-10-30
            2022-03-01
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            Chongqing Huapont Pharmaceutical

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            Application Number
            21653
            R1-CEP 2009-330 - Rev 00
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            Filing Details
            ISOTRETINOIN
            Isotretinoin
            Issue/Submission Date
            2008-05-23
            2016-10-13
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            Chongqing Huapont Pharmaceutical

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            Application Number
            34510
            CEP 2018-219 - Rev 01
            Status
            Active
            Fees Paid
            N/A
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            Filing Details
            ISOTRETINOIN
            Isotretinoin, Process 2
            Issue/Submission Date
            2020-02-12
            2023-12-06
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            Unipex

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            Shanghai New Hualian Pharmaceutical

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              Application Number
              R1-CEP 2008-231 - Rev 02
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              Isotretinoin
              Issue/Submission Date
              2020-06-22
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              Nishchem International Pvt. Ltd

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              Asia Pioneer Pharmaceuticals

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                R L Fine Chem

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                Hangzhou Deli Chemical

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                  Sionc Pharmaceuticals

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                  F. Hoffmann-La Roche

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                  Application Number
                  R1-CEP 2002-034 - Rev 01
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                  Isotretinoin
                  Issue/Submission Date
                  2008-11-25
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                  Srikem Laboratories Pvt. Ltd

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                  Sun Pharmaceutical Industries Limit...

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                  Application Number
                  Indian CDSCO WC-0011
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                  2025-06-02
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                  Isotretinoin (USP/Ph.Eur.)
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                  2022-06-08
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                  SAMEX OVERSEAS

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                    AASraw Biochemical Technology Co., ...

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                      Qingdao Qingmei Biotech

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                        Isotretinoin

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                        • CAPSULE;ORAL - 10MG
                        • CAPSULE;ORAL - 20MG
                        • CAPSULE;ORAL - 25MG
                        • CAPSULE;ORAL - 30MG
                        • CAPSULE;ORAL - 35MG
                        • CAPSULE;ORAL - 40MG

                        Looking for 4759-48-2 / Isotretinoin API manufacturers, exporters & distributors?

                        Isotretinoin manufacturers, exporters & distributors 1

                        17

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

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

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

                        API | Excipient name

                        Isotretinoin

                        Synonyms

                        4759-48-2, 13-cis-retinoic acid, Accutane, Roaccutane, Claravis, Neovitamin a acid

                        Cas Number

                        4759-48-2

                        Unique Ingredient Identifier (UNII)

                        EH28UP18IF

                        About Isotretinoin

                        A topical dermatologic agent that is used in the treatment of ACNE VULGARIS and several other skin diseases. The drug has teratogenic and other adverse effects.

                        Accutane Manufacturers

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

                        Accutane Suppliers

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

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

                        Accutane Manufacturers | Traders | Suppliers

                        Accutane Manufacturers, Traders, Suppliers 1
                        81

                        We have 28 companies offering Accutane

                        Get in contact with the supplier of your choice:

                        1. Biophore India Pharmaceuticals Pvt Ltd
                        2. LGM Pharma
                        3. Kimia Biosciences
                        4. AASraw Biochemical Technology Co., Ltd
                        5. Asia Pioneer Pharmaceuticals
                        6. BASF
                        7. Catalent Pharma Solutions
                        8. Chongqing Huapont Pharmaceutical
                        9. EASTMAN KODAK
                        10. F. Hoffmann-La Roche
                        11. Hangzhou Deli Chemical
                        12. Helsinn Advanced Synthesis
                        13. Hetero Drugs
                        14. Ipca Laboratories
                        15. JIANGXI HENGXIANG PHARMACEUTICAL TECHNOLOGY CO LTD
                        16. Nishchem International Pvt. Ltd
                        17. Olon S.p.A
                        18. Qingdao Qingmei Biotech
                        19. R L Fine Chem
                        20. RANBAXY LABORATORIES LIMITED
                        21. RP SCHERER GMBH & CO. KG
                        22. SAMEX OVERSEAS
                        23. Shanghai New Hualian Pharmaceutical
                        24. Siegfried AG
                        25. Sionc Pharmaceuticals
                        26. Srikem Laboratories Pvt. Ltd
                        27. Sun Pharmaceutical Industries Limited
                        28. Unipex
                        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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