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    01 16-Aminopenicillanic Acid

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    03 1Acalabrutinib

    04 1Adapalene

    05 1Afatinib

    06 1Agomelatine

    07 1Alendronate Sodium

    08 1Alogliptin Benzoate

    09 1Amantadine Hydrochloride

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    01

    Azithromycin Dihydrate

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

    FNCE
    Not Confirmed
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    Azithromycin Dihydrate

    India

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

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    FNCE
    Not Confirmed
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-02-12

    Pay. Date : 2016-01-28

    DMF Number : 20754

    Submission : 2007-07-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-165 - Rev 04

    Issue Date : 2022-04-06

    Type : Chemical

    Substance Number : 1649

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 306MF10146

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2024-11-20

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-22

    Valid Till : 2028-08-21

    Written Confirmation Number : WC-0082

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 46708-866

    Start Marketing Date : 2011-01-03

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    02

    Fenofibrate

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

    FNCE
    Not Confirmed
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    Fenofibrate

    India

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

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    FNCE
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-11

    Pay. Date : 2012-12-05

    DMF Number : 16208

    Submission : 2002-10-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-017 - Rev 00

    Issue Date : 2021-11-19

    Type : Chemical

    Substance Number : 1322

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10151

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2016-08-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-22

    Valid Till : 2028-08-21

    Written Confirmation Number : WC-0082

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Seongwoo Chemical Co., Ltd.

    Registration Date : 2024-09-05

    Registration Number : 20240116-209-J-1595(1)

    Manufacturer Name : Alembic Pharmaceuticals Limited (API Unit-1)

    Manufacturer Address : AT-Panelav, Tal-Halol, City: Panelav, Dist: Panchmahal, Gujarat State, 389 350, India

     VMF Others AUDIT
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    03

    Lamotrigine

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

    FNCE
    Not Confirmed
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    Lamotrigine

    India

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

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    FNCE
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-03-15

    Pay. Date : 2013-02-26

    DMF Number : 18732

    Submission : 2005-09-09

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2011-010 - Rev 05

    Issue Date : 2025-02-03

    Type : Chemical

    Substance Number : 1756

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10012

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2017-01-23

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-08

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0081

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    04

    Olmesartan Medoxomil

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

    FNCE
    Not Confirmed
    arrow

    Olmesartan Medoxomil

    India

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

    arrow
    FNCE
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-10-07

    Pay. Date : 2013-09-26

    DMF Number : 24671

    Submission : 2011-02-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2013-297 - Rev 01

    Issue Date : 2023-05-12

    Type : Chemical

    Substance Number : 2600

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 227MF10284

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2015-12-15

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-01

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0083

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Seongwoo Chemical Co., Ltd.

    Registration Date : 2014-03-18

    Registration Number : Su4579-2-ND

    Manufacturer Name : Alembic Pharmaceuticals Limited@[Manufacturer of starting material (Trityl Olmesartan Medoxomil)] Zhejiang Huahai Pharmaceutical Co., Ltd.

    Manufacturer Address : AT-Panelav, Tal-Halol, City : Panelav, Dist : Panchmahal, India.@Chuannan, Duqiao, Linhai, Zhejiang, China

     VMF Others AUDIT
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    05

    Ropinirole Hydrochloride

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

    FNCE
    Not Confirmed
    arrow

    Ropinirole Hydrochloride

    India

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

    arrow
    FNCE
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19780

    Submission : 2006-09-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2022-227 - Rev 00

    Issue Date : 2023-08-09

    Type : Chemical

    Substance Number : 2604

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10173

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2016-08-29

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-22

    Valid Till : 2028-08-21

    Written Confirmation Number : WC-0082

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2023-10-25

    Registration Number : 20190104-209-J-175(1)

    Manufacturer Name : Alembic Pharmaceuticals Limited (API Unit-I).

    Manufacturer Address : AT-Panelav, Tal-Halol, City : Panelav, Dist : Panchmahal, Gujarat State, India_x000D_

     VMF Others AUDIT
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    06

    Telmisartan

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

    FNCE
    Not Confirmed
    arrow

    Telmisartan

    India

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

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    FNCE
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-08

    Pay. Date : 2012-12-21

    DMF Number : 20285

    Submission : 2007-02-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2008-217 - Rev 07

    Issue Date : 2022-05-16

    Type : Chemical

    Substance Number : 2154

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 231MF10053

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2019-02-21

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-22

    Valid Till : 2028-08-21

    Written Confirmation Number : WC-0082

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Leaders Bio Co., Ltd.

    Registration Date : 2019-05-15

    Registration Number : 20180814-209-J-191(3)

    Manufacturer Name : Alembic Pharmaceuticals Limited (API Unit-1)

    Manufacturer Address : AT-Panelav, Tal-Halol, City : Panelav, Dist : Panchmahal, Gujarat State, India

     VMF Others AUDIT
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    07

    Vardenafil Hydrochloride

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

    FNCE
    Not Confirmed
    arrow

    Vardenafil Hydrochloride

    India

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

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    FNCE
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-02-20

    Pay. Date : 2014-12-24

    DMF Number : 28900

    Submission : 2014-12-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-095 - Rev 01

    Issue Date : 2023-06-26

    Type : Chemical

    Substance Number : 2782

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 301MF10002

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2019-05-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-22

    Valid Till : 2028-08-21

    Written Confirmation Number : WC-0082

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Mpeak Korea Co., Ltd.

    Registration Date : 2018-02-22

    Registration Number : 20180222-211-J-181

    Manufacturer Name : Alembic Pharmaceuticals Limited (API Unit-III)

    Manufacturer Address : Plot No. 842-843, Taluka-Padra, City : Karakhadi - 391 450, District-Vadodara Gujarat State, India

     VMF Others AUDIT
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    08

    Venlafaxine Hydrochloride

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

    FNCE
    Not Confirmed
    arrow

    Venlafaxine Hydrochloride

    India

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

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    FNCE
    Not Confirmed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16551

    Submission : 2003-04-29

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2006-225 - Rev 05

    Issue Date : 2024-01-29

    Type : Chemical

    Substance Number : 2119

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 304MF10131

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2022-09-21

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-22

    Valid Till : 2028-08-21

    Written Confirmation Number : WC-0082

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    09

    Apixaban

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

    FNCE
    Not Confirmed
    arrow

    Apixaban

    India

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

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    FNCE
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-12-18

    Pay. Date : 2014-12-24

    DMF Number : 29660

    Submission : 2015-09-30

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 307MF10036

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2025-02-19

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-22

    Valid Till : 2028-08-21

    Written Confirmation Number : WC-0082

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Seongwoo Chemical Co., Ltd.

    Registration Date : 2024-07-25

    Registration Number : Su473-31-ND

    Manufacturer Name : Alembic Pharmaceuticals Limited (API Unit-lll)

    Manufacturer Address : API Division Karakhadi, Plot No. 842-843 Tal-Padra, AT.- Karakhadi-391 450, Dist.- Vadodara, Gujarat State, India

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    10

    Aripiprazole

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

    FNCE
    Not Confirmed
    arrow

    Aripiprazole

    India

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

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-08-28

    Pay. Date : 2013-08-19

    DMF Number : 23300

    Submission : 2009-11-18

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2013-292 - Rev 02

    Issue Date : 2024-08-27

    Type : Chemical

    Substance Number : 2617

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-22

    Valid Till : 2028-08-21

    Written Confirmation Number : WC-0082

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 46708-837

    Start Marketing Date : 2015-05-22

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2022-12-22

    Registration Number : 20221222-209-J-1427

    Manufacturer Name : Alembic Pharmaceuticals Limited

    Manufacturer Address : API Division Karakhadi, Plot No. 842-843 Tal-Padra, City : Karakhadi-391 450, Dist : Vadodara, Gujarat State, India

     VMF Others AUDIT
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    Contact Alembic Pharmaceuticals Limited and get a quotation

    Alembic Pharmaceuticals Limited is a supplier offers 235 products (APIs, Excipients or Intermediates).

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