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    01

    Amlodipine Besylate

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

    CPhI WW Frankfurt
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    Amlodipine Besylate

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-03-17

    Pay. Date : 2017-03-06

    DMF Number : 17032

    Submission : 2003-12-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2006-067 - Rev 01

    Issue Date : 2014-07-28

    Type : Chemical

    Substance Number : 1491

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 221MF10131

    Registrant's Address : Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400 013, INDIA

    Initial Date of Registration : 2009-06-30

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-26

    Valid Till : 2028-08-08

    Written Confirmation Number : WC-0113

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 53104-7561

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (35kg/35kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Boehringer Ingelheim Korea Co., Ltd.

    Registration Date : 2021-11-05

    Registration Number : 20101029-130-H-18-03(4)

    Manufacturer Name : Cipla Limited

    Manufacturer Address : Virgonagar Post, Old Madras Road, Bangalore-560 049, India

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    02

    Celecoxib

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

    CPhI WW Frankfurt
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    Celecoxib

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-09-28

    Pay. Date : 2013-09-20

    DMF Number : 16671

    Submission : 2003-06-30

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2014-186 - Rev 01

    Issue Date : 2023-05-30

    Type : Chemical

    Substance Number : 2591

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 230MF10110

    Registrant's Address : Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400 013, INDIA

    Initial Date of Registration : 2018-08-20

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-12

    Valid Till : 2028-09-08

    Written Confirmation Number : WC-0144

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 53104-7533

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Ildong Pharmaceutical Co., Ltd.

    Registration Date : 2020-09-08

    Registration Number : 20190104-209-J-128(4)

    Manufacturer Name : Cipla Limited

    Manufacturer Address : D-7, MIDC, Industrial Area, Kurkumbh, Taluka Daund, Pune 413 802, Maharashtra State, India

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    03

    Etoposide

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

    CPhI WW Frankfurt
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    India

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10642

    Submission : 1993-12-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2007-061 - Rev 06

    Issue Date : 2024-09-17

    Type : Chemical

    Substance Number : 823

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10214

    Registrant's Address : Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400 013, INDIA

    Initial Date of Registration : 2010-08-05

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-26

    Valid Till : 2028-08-08

    Written Confirmation Number : WC-0113

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 53104-7514

    Start Marketing Date : 2018-07-13

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (4kg/4kg)

    Marketing Category : BULK INGREDIENT

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    04

    Abacavir Sulfate

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

    CPhI WW Frankfurt
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    Abacavir Sulfate

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-07-29

    Pay. Date : 2013-03-13

    DMF Number : 26299

    Submission : 2012-08-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2014-187 - Rev 00

    Issue Date : 2021-01-20

    Type : Chemical

    Substance Number : 2589

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-06-20

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0140

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 53104-7558

    Start Marketing Date : 2018-04-05

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

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    05

    Alendronate Sodium

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

    CPhI WW Frankfurt
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    Alendronate Sodium

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-12-15

    Pay. Date : 2019-12-11

    DMF Number : 14334

    Submission : 1999-08-06

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2005-126 - Rev 04

    Issue Date : 2018-08-29

    Type : Chemical

    Substance Number : 1564

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-12

    Valid Till : 2028-09-08

    Written Confirmation Number : WC-0144

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 53104-7525

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

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    06

    Bicalutamide

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

    CPhI WW Frankfurt
    Attending
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    Bicalutamide

    India

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

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18723

    Submission : 2005-08-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2014-191 - Rev 00

    Issue Date : 2021-08-03

    Type : Chemical

    Substance Number : 2196

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-26

    Valid Till : 2028-08-08

    Written Confirmation Number : WC-0138

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 53104-7664

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (30kg/30kg)

    Marketing Category : BULK INGREDIENT

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    07

    Budesonide

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

    CPhI WW Frankfurt
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    Budesonide

    India

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

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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-06-01

    Pay. Date : 2014-11-12

    DMF Number : 27461

    Submission : 2014-03-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2006-061 - Rev 03

    Issue Date : 2024-06-21

    Type : Chemical

    Substance Number : 1075

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-12

    Valid Till : 2028-09-08

    Written Confirmation Number : WC-0144

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 53104-7617

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

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    08

    Cetirizine Dihydrochloride

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

    CPhI WW Frankfurt
    Attending
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    Cetirizine Dihydrochloride

    India

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

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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-03-25

    Pay. Date : 2016-03-08

    DMF Number : 15145

    Submission : 2000-11-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2000-081 - Rev 07

    Issue Date : 2019-08-09

    Type : Chemical

    Substance Number : 1084

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-29

    Valid Till : 2028-08-28

    Written Confirmation Number : WC-0142

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 53104-7528

    Start Marketing Date : 2018-12-07

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (20kg/20kg)

    Marketing Category : BULK INGREDIENT

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    Registrant Name : HanAll Biopharma Co., Ltd.

    Registration Date : 2011-11-18

    Registration Number : 20080829-40-C-239-12(6)

    Manufacturer Name : Cipla Limited

    Manufacturer Address : A-33& A-37/2/2, MIDC, Patalganga-410 220, District:Raigad, Maharashtra State

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    Efinaconazole

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-04-20

    Pay. Date : 2018-02-23

    DMF Number : 32317

    Submission : 2018-02-09

    Status : Active

    Type : II

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    Registration Number : 302MF10122

    Registrant's Address : Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400 013, INDIA

    Initial Date of Registration : 2020-10-05

    Latest Date of Registration :

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    Date of Issue : 2025-08-29

    Valid Till : 2028-08-28

    Written Confirmation Number : WC-0142

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    Registrant Name : Dongwha Pharmaceutical Co., Ltd.

    Registration Date : 2022-08-03

    Registration Number : Su496-27-ND(2)

    Manufacturer Name : Cipla Limited.

    Manufacturer Address : Plot NOS. A-2, A-33 & A-37/2/2, MIDC, Patalganga, Raigad 410220 Maharashtra State, India

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    Esomeprazole Magnesium

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

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    India

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-04-10

    Pay. Date : 2013-04-03

    DMF Number : 18821

    Submission : 2005-09-28

    Status : Active

    Type : II

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    Certificate Number : R1-CEP 2015-320 - Rev 00

    Issue Date : 2022-08-22

    Type : Chemical

    Substance Number : 2372

    Status : Valid

     JDMF EU-WCarrow-down
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    Date of Issue : 2025-08-26

    Valid Till : 2028-08-08

    Written Confirmation Number : WC-0113

    Address of the Firm :

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    NDC Package Code : 53104-7554

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (20kg/20kg)

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Chong Kun Dang Co., Ltd.

    Registration Date : 2015-08-17

    Registration Number : 20101230-127-H-10-04(1)

    Manufacturer Name : Cipla Limited

    Manufacturer Address : Virgonagar Post, Old Madras Road, Bangalore - 560 049, India

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