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    Huzhou Zhanwang Pharmaceutical

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AIChE Annual Meeting
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    Huzhou Zhanwang Pharmaceutical

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    AIChE Annual Meeting
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37745

    Submission : 2022-11-29

    Status : Active

    Type : IV

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    02

    MLA Group

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AIChE Annual Meeting
    Not Confirmed
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    MLA Group

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    AIChE Annual Meeting
    Not Confirmed
    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37656

    Submission : 2022-11-05

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    03

    Lipidchem Sdn

    Malaysia

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AIChE Annual Meeting
    Not Confirmed
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    Lipidchem Sdn

    Malaysia

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    AIChE Annual Meeting
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23613

    Submission : 2010-03-08

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    04

    BASF

    Germany

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AIChE Annual Meeting
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    BASF

    Germany

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    AIChE Annual Meeting
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17763

    Submission : 2004-09-28

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    05

    Hemo Asia

    Malaysia

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AIChE Annual Meeting
    Not Confirmed
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    Hemo Asia

    Malaysia

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    AIChE Annual Meeting
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17995

    Submission : 2004-12-30

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    06

    Anmol Chemicals

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AIChE Annual Meeting
    Not Confirmed
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    Anmol Chemicals

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    AIChE Annual Meeting
    Not Confirmed
    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37199

    Submission : 2022-06-17

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    07

    Ambrogio Pagani SpA IT 24126 Berga...

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AIChE Annual Meeting
    Not Confirmed
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    Ambrogio Pagani SpA IT 24126 Berga...

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    AIChE Annual Meeting
    Not Confirmed
    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2000-269 - Rev 00

    Issue Date : 2006-02-13

    Type : TSE

    Substance Number : 1474

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    08

    Union Derivan S.A. ES 08840 Vilade...

    Spain

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AIChE Annual Meeting
    Not Confirmed
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    Union Derivan S.A. ES 08840 Vilade...

    Spain

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    AIChE Annual Meeting
    Not Confirmed
    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2001-081 - Rev 02

    Issue Date : 2015-07-10

    Type : TSE

    Substance Number : 1474

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    09

    PMC Biogenix

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AIChE Annual Meeting
    Not Confirmed
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    PMC Biogenix

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    AIChE Annual Meeting
    Not Confirmed
    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2001-001 - Rev 01

    Issue Date : 2008-05-16

    Type : TSE

    Substance Number : 1474

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    10

    Mallinckrodt Pharmaceuticals

    Ireland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AIChE Annual Meeting
    Not Confirmed
    arrow

    Mallinckrodt Pharmaceuticals

    Ireland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AIChE Annual Meeting
    Not Confirmed
    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2000-222 - Rev 00

    Issue Date : 2006-08-01

    Type : TSE

    Substance Number : 1474

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    USDMF

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    01

    Anmol Chemicals

    India

    USDMF

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    AIChE Annual Meeting
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    01

    Anmol Chemicals

    India
    arrow
    AIChE Annual Meeting
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37199

    Submission : 2022-06-17

    Status : Active

    Type : IV

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    02

    Basf Se

    Germany

    USDMF

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    02

    Basf Se

    Germany
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    AIChE Annual Meeting
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17763

    Submission : 2004-09-28

    Status : Active

    Type : IV

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    03

    Hesego Industry Sdn Bhd

    Malaysia

    USDMF

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    AIChE Annual Meeting
    Not Confirmed

    03

    Hesego Industry Sdn Bhd

    Malaysia
    arrow
    AIChE Annual Meeting
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17995

    Submission : 2004-12-30

    Status : Active

    Type : IV

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    04

    AIChE Annual Meeting
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    04

    Huzhou Zhanwang Pharmaceutical Co Lt...

    China
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    AIChE Annual Meeting
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37745

    Submission : 2022-11-29

    Status : Active

    Type : IV

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    05

    AIChE Annual Meeting
    Not Confirmed

    05

    Lipidchem Sendirian Berhad

    Malaysia
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    AIChE Annual Meeting
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23613

    Submission : 2010-03-08

    Status : Active

    Type : IV

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    06

    Mla Industries

    India

    USDMF

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    AIChE Annual Meeting
    Not Confirmed

    06

    Mla Industries

    India
    arrow
    AIChE Annual Meeting
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37656

    Submission : 2022-11-05

    Status : Active

    Type : IV

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    CEP/COS

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    Ambrogio Pagani SpA Bergamo IT

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      Stearic acid

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      R1-CEP 2000-269 - Rev 00
      Valid
      TSE
      2006-02-13
      1474
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      01

      Ambrogio Pagani SpA Bergamo IT

      Italy
      AIChE Annual Meeting
      Not Confirmed
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      Ambrogio Pagani SpA Bergamo IT

      Italy
      arrow
      AIChE Annual Meeting
      Not Confirmed
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      Stearic Acid

      Certificate Number : R1-CEP 2000-269 - Rev 00

      Status : Valid

      Issue Date : 2006-02-13

      Type : TSE

      Substance Number : 1474

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      Chemtura Corporation Middlebury US

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        Stearic acid, Industrene® 8718

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        R1-CEP 2001-004 - Rev 00
        Valid
        TSE
        2006-10-17
        1474
        blank

        02

        Chemtura Corporation Middlebury US

        U.S.A
        AIChE Annual Meeting
        Not Confirmed
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        Chemtura Corporation Middlebury US

        U.S.A
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        AIChE Annual Meeting
        Not Confirmed
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        Stearic Acid, Industrene® 8718

        Certificate Number : R1-CEP 2001-004 - Rev 00

        Status : Valid

        Issue Date : 2006-10-17

        Type : TSE

        Substance Number : 1474

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        Chemtura Corporation Middlebury US

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          Stearic acid, Hystrene® 9718

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          R1-CEP 2001-003 - Rev 00
          Valid
          TSE
          2006-10-17
          1474
          blank

          03

          Chemtura Corporation Middlebury US

          U.S.A
          AIChE Annual Meeting
          Not Confirmed
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          Chemtura Corporation Middlebury US

          U.S.A
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          AIChE Annual Meeting
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          Stearic Acid, Hystrene® 9718

          Certificate Number : R1-CEP 2001-003 - Rev 00

          Status : Valid

          Issue Date : 2006-10-17

          Type : TSE

          Substance Number : 1474

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          Chemtura Corporation Middlebury US

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            Stearic acid, Industrene® 7018

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            R1-CEP 2001-009 - Rev 00
            Valid
            TSE
            2006-12-14
            1474
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            04

            Chemtura Corporation Middlebury US

            U.S.A
            AIChE Annual Meeting
            Not Confirmed
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            Chemtura Corporation Middlebury US

            U.S.A
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            AIChE Annual Meeting
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            Stearic Acid, Industrene® 7018

            Certificate Number : R1-CEP 2001-009 - Rev 00

            Status : Valid

            Issue Date : 2006-12-14

            Type : TSE

            Substance Number : 1474

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            Chemtura Corporation Middlebury US

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              Stearic acid, Hystrene® 7018

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              R1-CEP 2001-002 - Rev 00
              Valid
              TSE
              2006-10-17
              1474
              blank

              05

              Chemtura Corporation Middlebury US

              U.S.A
              AIChE Annual Meeting
              Not Confirmed
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              Chemtura Corporation Middlebury US

              U.S.A
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              AIChE Annual Meeting
              Not Confirmed
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              Stearic Acid, Hystrene® 7018

              Certificate Number : R1-CEP 2001-002 - Rev 00

              Status : Valid

              Issue Date : 2006-10-17

              Type : TSE

              Substance Number : 1474

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              EMERY OLEOCHEMICALS CANADA LTD. Tor...

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                Stearic acid, Emersol® 6320, 6332 and 6349

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                R1-CEP 2001-101 - Rev 01
                Valid
                TSE
                2009-08-31
                1474
                blank

                06

                EMERY OLEOCHEMICALS CANADA LTD. Tor...

                U.S.A
                AIChE Annual Meeting
                Not Confirmed
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                Mallinckrodt Inc St Louis US

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                Stearic acid, Code number 2216

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                R1-CEP 2000-222 - Rev 00
                Valid
                TSE
                2006-08-01
                1474
                blank

                07

                Mallinckrodt Inc St Louis US

                Ireland
                AIChE Annual Meeting
                Not Confirmed
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                Mallinckrodt Inc St Louis US

                Ireland
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                AIChE Annual Meeting
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                Stearic Acid, Code Number 2216

                Certificate Number : R1-CEP 2000-222 - Rev 00

                Status : Valid

                Issue Date : 2006-08-01

                Type : TSE

                Substance Number : 1474

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                PMC BIOGENIX, INC. Memphis US

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                Stearic acid, Hystrene® 5016

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                R1-CEP 2001-001 - Rev 01
                Valid
                TSE
                2008-05-16
                1474
                blank

                08

                PMC BIOGENIX, INC. Memphis US

                U.S.A
                AIChE Annual Meeting
                Not Confirmed
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                PMC BIOGENIX, INC. Memphis US

                U.S.A
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                AIChE Annual Meeting
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                Stearic Acid, Hystrene® 5016

                Certificate Number : R1-CEP 2001-001 - Rev 01

                Status : Valid

                Issue Date : 2008-05-16

                Type : TSE

                Substance Number : 1474

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                SO.G.I.S Industria Chimica SpA Sosp...

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                  Stearic acid

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                  R1-CEP 2000-278 - Rev 00
                  Valid
                  TSE
                  2006-04-02
                  1474
                  blank

                  09

                  SO.G.I.S Industria Chimica SpA Sosp...

                  Italy
                  AIChE Annual Meeting
                  Not Confirmed
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                  SO.G.I.S Industria Chimica SpA Sosp...

                  Italy
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                  Stearic Acid

                  Certificate Number : R1-CEP 2000-278 - Rev 00

                  Status : Valid

                  Issue Date : 2006-04-02

                  Type : TSE

                  Substance Number : 1474

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                  Uniqema GmbH & Co. KG Emmerich DE

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                    Stearic acid

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                    R1-CEP 2000-389 - Rev 01
                    Withdrawn by Holder
                    TSE
                    2010-03-03
                    2011-03-01
                    1474
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                    Uniqema GmbH & Co. KG Emmerich DE

                    Germany
                    AIChE Annual Meeting
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                    Uniqema GmbH & Co. KG Emmerich DE

                    Germany
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                    Stearic Acid

                    Certificate Number : R1-CEP 2000-389 - Rev 01

                    Status : Withdrawn by Holder

                    Issue Date : 2010-03-03

                    Type : TSE

                    Substance Number : 1474

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                    EU WC

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                    01

                    Taurus Chemicals

                    India
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                    Stearic Acid BP/EP/USP-NF

                    Date of Issue : 2022-09-30

                    Valid Till : 2025-02-07

                    Written Confirmation Number : WC-0187

                    Address of the Firm : S.V. Co-operative Industrial Estate, IDA, Bollaram, Bollaram (V), Jinnaram (M), ...

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                    FINISHED DOSAGE FORMULATIONS

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                    FDA Listed Dossiers

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                    01

                    Dosage Form : TABLET

                    STEARIC ACID
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                    Dosage Form : TABLET

                    USA
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                    STEARIC ACID

                    Route : BUCCAL

                    CAS : 57-11-4

                    UNII : 4ELV7Z65AP

                    Potency Amount : 5

                    Potency Unit : MG

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                    02

                    Dosage Form : TABLET

                    STEARIC ACID
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                    STEARIC ACID

                    Route : BUCCAL/SUBLINGUAL

                    CAS : 57-11-4

                    UNII : 4ELV7Z65AP

                    Potency Amount : 6

                    Potency Unit : MG

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                    03

                    Dosage Form : PELLET

                    STEARIC ACID
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                    Dosage Form : PELLET

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                    STEARIC ACID

                    Route : IMPLANTATION

                    CAS : 57-11-4

                    UNII : 4ELV7Z65AP

                    Potency Amount : 0.2

                    Potency Unit : MG

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                    04

                    Dosage Form : CAPSULE

                    STEARIC ACID
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                    STEARIC ACID

                    Route : ORAL

                    CAS : 57-11-4

                    UNII : 4ELV7Z65AP

                    Potency Amount : 52

                    Potency Unit : MG

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                    05

                    Dosage Form : CAPSULE, COATED, SOFT GELATIN

                    STEARIC ACID
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                    Dosage Form : CAPSULE, COATED, SOFT GELATIN

                    USA
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                    STEARIC ACID

                    Route : ORAL

                    CAS : 57-11-4

                    UNII : 4ELV7Z65AP

                    Potency Amount : 3

                    Potency Unit : MG

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                    06

                    Dosage Form : CAPSULE, DELAYED ACTION

                    STEARIC ACID
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                    Dosage Form : CAPSULE, DELAYED ACTION

                    USA
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                    STEARIC ACID

                    Route : ORAL

                    CAS : 57-11-4

                    UNII : 4ELV7Z65AP

                    Potency Amount : 3

                    Potency Unit : MG

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                    07

                    Dosage Form : CAPSULE, EXTENDED RELEASE

                    STEARIC ACID
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                    Dosage Form : CAPSULE, EXTENDED RELEASE

                    USA
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                    STEARIC ACID

                    Route : ORAL

                    CAS : 57-11-4

                    UNII : 4ELV7Z65AP

                    Potency Amount : 3.23

                    Potency Unit : MG

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                    08

                    Dosage Form : CAPSULE, HARD GELATIN

                    STEARIC ACID
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                    Dosage Form : CAPSULE, HARD GELATIN

                    USA
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                    STEARIC ACID

                    Route : ORAL

                    CAS : 57-11-4

                    UNII : 4ELV7Z65AP

                    Potency Amount : 15

                    Potency Unit : MG

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                    09

                    Dosage Form : CAPSULE, SUSTAINED ACTION

                    STEARIC ACID
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                    Dosage Form : CAPSULE, SUSTAINED ACTION

                    USA
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                    STEARIC ACID

                    Route : ORAL

                    CAS : 57-11-4

                    UNII : 4ELV7Z65AP

                    Potency Amount : 21

                    Potency Unit : MG

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                    10

                    Dosage Form : POWDER, FOR SUSPENSION

                    STEARIC ACID
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                    Dosage Form : POWDER, FOR SUSPENSION

                    USA
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                    STEARIC ACID

                    Route : ORAL

                    CAS : 57-11-4

                    UNII : 4ELV7Z65AP

                    Potency Amount : 1203

                    Potency Unit : MG/5ML

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