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    05 1Aficamten

    06 10Amlodipine Besylate

    07 2Apalutamide

    08 2Apixaban

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    27 16Clopidogrel

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    29 1Dapagliflozin

    30 2Dapagliflozin Propanediol Monohydrate

    31 1Darolutamide

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    35 1Dimethyl Fumarate

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    01

    Capecitabine

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 22479

    Submission : 2009-01-30

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2014-109 - Rev 02

    Issue Date : 2022-09-13

    Type : Chemical

    Substance Number : 2762

    Status : Valid

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    Registration Number : 304MF10153

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2022-12-07

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    Date of Issue : 2025-07-15

    Valid Till : 2028-07-07

    Written Confirmation Number : WC-0067

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    NDC Package Code : 55111-893

    Start Marketing Date : 2012-07-30

    End Marketing Date : 2026-12-31

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    Registrant Name : Pamirae Co., Ltd.

    Registration Date : 2024-04-09

    Registration Number : 20240409-209-J-1615

    Manufacturer Name : Dr. Reddy's Laboratories Limited

    Manufacturer Address : CTO Unit-VI, APIIC Industrial Estate, Pydibhimavaram Village, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh - 532 409, India

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    02

    Cetirizine Dihydrochloride

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-06-16

    Pay. Date : 2014-06-06

    DMF Number : 18395

    Submission : 2005-05-27

    Status : Active

    Type : II

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    Certificate Number : R1-CEP 2003-049 - Rev 07

    Issue Date : 2018-10-01

    Type : Chemical

    Substance Number : 1084

    Status : Valid

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    Registration Number : 218MF10306

    Registrant's Address : 8-2-337, Road No. 3,Banjara Hills,Hyderabad 500 034,TELANGANA,INDIA

    Initial Date of Registration : 2006-04-20

    Latest Date of Registration :

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    Date of Issue : 2025-06-20

    Valid Till : 2028-07-07

    Written Confirmation Number : WC-0039

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    Registrant Name : Pamirae Co., Ltd.

    Registration Date : 2022-09-16

    Registration Number : 20050831-40-C-145-06(4)

    Manufacturer Name : Dr. Reddy's Laboratories Limited

    Manufacturer Address : Plot No. 137 & 138, 145 & 146, Sri Venkateswara Co-operative industrial estate,Bollaram, Jinnaram Mandal, Sangareddy District, Telangana state, INDIA

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    03

    Clopidogrel

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-30

    Pay. Date : 2013-01-04

    DMF Number : 16090

    Submission : 2002-08-07

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R0-CEP 2021-052 - Rev 01

    Issue Date : 2023-02-20

    Type : Chemical

    Substance Number : 2531

    Status : Valid

     JDMF arrow-down
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    Registration Number : 304MF10059

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2022-03-30

    Latest Date of Registration :

    EU-WCarrow-down
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    Date of Issue : 2025-06-20

    Valid Till : 2028-07-07

    Written Confirmation Number : WC-0039

    Address of the Firm :

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    NDC Package Code : 71796-027

    Start Marketing Date : 2020-12-30

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Agerson Bio Co., Ltd.

    Registration Date : 2025-02-05

    Registration Number : 20110225-129-H-88-15(17)

    Manufacturer Name : Dr. Reddy's Laboratories Limited

    Manufacturer Address : CTO - Unit-I, Plot Nos. 137,138,145 & 146, SV Co-Op, Industrial Estate, Bollaram Village, Jinnaram Mandal, Sangareddy District, Telangana - 502 325, INDIA

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    04

    Fexofenadine Hydrochloride

    India

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2020-12-12

    Pay. Date : 2020-12-04

    DMF Number : 15757

    Submission : 2001-12-05

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R0-CEP 2021-067 - Rev 00

    Issue Date : 2023-07-06

    Type : Chemical

    Substance Number : 2280

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 302MF10124

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2020-10-05

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-07-25

    Valid Till : 2028-06-04

    Written Confirmation Number : WC-0043

    Address of the Firm :

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    NDC Package Code : 71796-015

    Start Marketing Date : 2020-03-12

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Sangjin Trading Co., Ltd.

    Registration Date : 2022-10-06

    Registration Number : 20221006-209-J-1373

    Manufacturer Name : Dr. Reddy's Laboratories Ltd.

    Manufacturer Address : Peddadevulapalli Village, Tripuraram Mandal, Nalgonda District, Telangana State, India - 508207

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    05

    Gemcitabine

    India

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    Booth #5D18
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-06-27

    Pay. Date : 2016-06-06

    DMF Number : 18857

    Submission : 2005-10-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-075 - Rev 06

    Issue Date : 2021-06-18

    Type : Chemical

    Substance Number : 2306

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 220MF10243

    Registrant's Address : 8-2-337, Road No. 3,Banjara Hills,Hyderabad 500 034,TELANGANA,INDIA

    Initial Date of Registration : 2008-12-04

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-06-20

    Valid Till : 2028-07-07

    Written Confirmation Number : WC-0039

    Address of the Firm :

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    Registrant Name : Korea United Pharmaceutical Co., Ltd.

    Registration Date : 2012-05-18

    Registration Number : 20070928-86-D-51-03(3)

    Manufacturer Name : Dr. Reddy's Laboratories Limited

    Manufacturer Address : CTO - Unit-I, Plot Nos. 137,138,145 & 146, SV Co-Op, Industrial Estate, Bollaram Village, Jinnaram Mandal, Sangareddy District, Telangana - 502 325, INDIA

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    06

    Montelukast Sodium

    India

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-02-18

    Pay. Date : 2012-12-31

    DMF Number : 24516

    Submission : 2010-12-31

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2012-115 - Rev 03

    Issue Date : 2023-07-12

    Type : Chemical

    Substance Number : 2583

    Status : Valid

     JDMF arrow-down
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    Registration Number : 307MF10039

    Registrant's Address : 8-2-337, Road No. 3,Banjara Hills,Hyderabad 500 034,TELANGANA,INDIA

    Initial Date of Registration : 2025-02-26

    Latest Date of Registration :

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    Date of Issue : 2025-07-25

    Valid Till : 2028-06-04

    Written Confirmation Number : WC-0043

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    NDC Package Code : 55111-084

    Start Marketing Date : 2010-12-31

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Pamirae Co., Ltd.

    Registration Date : 2022-06-29

    Registration Number : 20220629-209-J-1272

    Manufacturer Name : Dr. Reddy's Laboratories Ltd.

    Manufacturer Address : Chemical Technical Operations-Unit-Ⅴ, Peddadevulapally Village, Tripuraram Mandal, Nalgonda District, 508 207, Telangana State, India

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    07

    Nizatidine

    India

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-09-04

    Pay. Date : 2013-08-23

    DMF Number : 14036

    Submission : 1999-03-16

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2002-027 - Rev 06

    Issue Date : 2023-04-24

    Type : Chemical

    Substance Number : 1453

    Status : Valid

     JDMF arrow-down
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    Registration Number : 218MF10215

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2006-02-16

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-07-15

    Valid Till : 2028-07-07

    Written Confirmation Number : WC-0067

    Address of the Firm :

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    NDC Package Code : 55111-011

    Start Marketing Date : 2012-07-13

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Bansen Co., Ltd.

    Registration Date : 2021-05-28

    Registration Number : 20121220-144-I-186-02(14)

    Manufacturer Name : Dr. Reddy's Laboratories Limited

    Manufacturer Address : APIIC Industrial Estate, Pydibhimavaram, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh, India

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    08

    Ondansetron Hydrochloride

    India

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-09-23

    Pay. Date : 2015-09-09

    DMF Number : 15436

    Submission : 2001-05-15

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2005-071 - Rev 06

    Issue Date : 2023-05-23

    Type : Chemical

    Substance Number : 2016

    Status : Valid

     JDMF arrow-down
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    Registration Number : 302MF10019

    Registrant's Address : 8-2-337, Road No. 3,Banjara Hills,Hyderabad 500 034,TELANGANA,INDIA

    Initial Date of Registration : 2020-01-31

    Latest Date of Registration :

    EU-WCarrow-down
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    Date of Issue : 2025-07-25

    Valid Till : 2028-06-04

    Written Confirmation Number : WC-0043

    Address of the Firm :

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    NDC Package Code : 55111-017

    Start Marketing Date : 2010-01-01

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Sangjin Trading Co., Ltd.

    Registration Date : 2021-06-22

    Registration Number : 20210426-47-B-440-20(1)

    Manufacturer Name : Dr. Reddy's Laboratories Ltd.

    Manufacturer Address : Peddadevulapally Village, Tripuraram Mandal, Nalgonda District - 508 207, Telangana State, India

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    09

    Quetiapine Hemifumarate

    India

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    Booth #5D18
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17122

    Submission : 2004-01-29

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2014-200 - Rev 01

    Issue Date : 2024-03-15

    Type : Chemical

    Substance Number : 2541

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 306MF10157

    Registrant's Address : 8-2-337, Road No. 3,Banjara Hills,Hyderabad 500 034,TELANGANA,INDIA

    Initial Date of Registration : 2024-12-11

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-07-15

    Valid Till : 2028-07-07

    Written Confirmation Number : WC-0067

    Address of the Firm :

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    NDC Package Code : 55111-053

    Start Marketing Date : 2004-01-29

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Sangjin Trading Co., Ltd.

    Registration Date : 2012-06-28

    Registration Number : 20120628-172-I-86-04

    Manufacturer Name : Dr. Reddy's Laboratories Limited

    Manufacturer Address : Chemical Technical Operations, Unit-VI, APIIC Industrial Estate, Pydibhimavaram, Ranasthalam Mandal, Srikakulam District - 532409, Andhra Pradesh, India.

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    Rabeprazole Sodium

    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 : 16747

    Submission : 2003-08-04

    Status : Active

    Type : II

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    Certificate Number : R0-CEP 2021-023 - Rev 00

    Issue Date : 2023-01-10

    Type : Chemical

    Substance Number : 2868

    Status : Valid

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    Registration Number : 303MF10057

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2021-04-02

    Latest Date of Registration :

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    Date of Issue : 2025-05-28

    Valid Till : 2028-06-25

    Written Confirmation Number : WC-0035

    Address of the Firm :

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    NDC Package Code : 55111-055

    Start Marketing Date : 2010-01-30

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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