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    Ami Lifesciences Submits US DMF for Tegoprazan

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    02 Aug 2024

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    01 2Acebrophylline

    02 2Alpha Lipoic Acid

    03 2Ambroxol Hydrochloride

    04 2Azilsartan

    05 1Bempedoic Acid

    06 10Benfotiamine

    07 1Benzonatate

    08 2Betahistine Dihydrochloride

    09 1Bilastine

    10 4Bisbentiamine

    11 1Brivaracetam

    12 1Choline Fenofibrate

    13 1Dapagliflozin

    14 1Dapagliflozin Propanediol Monohydrate

    15 1Dapoxetine Hydrochloride

    16 1Daprodustat

    17 1Desvenlafaxine Succinate

    18 1Deucravacitinib

    19 7Diacerein

    20 1Dicyclomine Hydrochloride

    21 3Doxofylline

    22 1Edoxaban Tosylate

    23 1Empagliflozin

    24 1Eslicarbazepine Acetate

    25 1Febuxostat

    26 1Fenofibrate

    27 1Fexofenadine Hydrochloride

    28 2Fimasartan

    29 1Finerenone

    30 1Flavoxate

    31 1Fursultiamine

    32 1Gliclazide

    33 1Hydralazine Hydrochloride

    34 1Imeglimin Hydrochloride

    35 5Itopride Hydrochloride

    36 1Levocloperastine Fendizoate

    37 1Mirabegron

    38 1Mirogabalin Besylate

    39 1Obeticholic Acid

    40 1Oxcarbazepine

    41 1Pamabrom

    42 1Pemafibrate

    43 1Resmetirom

    44 1Rivaroxaban

    45 1Roxadustat

    46 1Rutin

    47 1Sacubitril Sodium

    48 1Sacubitril-Valsartan

    49 1Sevelamer Carbonate

    50 1Sevelamer Hydrochloride

    51 1Sitagliptin Hydrochloride

    52 2Sitagliptin Phosphate

    53 1Tadalafil

    54 1Tapentadol

    55 1Tapentadol Phosphate

    56 2Tegoprazan

    57 1Teneligliptin Hydrobromide

    58 1Tolvaptan

    59 1Tranexamic Acid

    60 1Trelagliptin Succinate

    61 1Vadadustat

    62 1Venlafaxine Hydrochloride

    63 1Vibegron

    64 1Vildagliptin

    65 1Vonoprazan Fumarate

    66 1Xanthinol Nicotinate

    67 5Blank

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    01

    Ambroxol Hydrochloride

    India

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

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    USDMF CEP/COS arrow-down
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    Certificate Number : R0-CEP 2023-168 - Rev 00

    Issue Date : 2023-08-23

    Type : Chemical

    Substance Number : 1489

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 305MF10118

    Registrant's Address : 2nd Floor, Prestige Plaza-40, Urmi Society, Near Urmi Cross Road, BPC Road, Akota, Vadodara-390 020, Gujarat, India

    Initial Date of Registration : 2023-11-01

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-11

    Valid Till : 2025-06-26

    Written Confirmation Number : WC-0054

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Hanmi Pharmaceutical Co., Ltd.

    Registration Date : 2023-02-27

    Registration Number : 20221028-45-B-470-06(1)

    Manufacturer Name : Ami Lifesciences Private Limited

    Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Dist : Vadodara, Gujarat State India

     VMF CN, MX arrow-down
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    02

    Diacerein

    India

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

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38766

    Submission : 2023-09-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2015-173 - Rev 03

    Issue Date : 2024-12-03

    Type : Chemical

    Substance Number : 2409

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-11

    Valid Till : 2025-06-26

    Written Confirmation Number : WC-0054

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 59680-014

    Start Marketing Date : 2024-04-09

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Huseeed Co., Ltd.

    Registration Date : 2021-11-30

    Registration Number : 20180515-209-J-27(6)

    Manufacturer Name : Ami Lifesciences Pvt. Ltd.

    Manufacturer Address : Block No. 82/B, ECP Road, At & Post. Karakhadi-391 450, Taluka:Padra, Dist.Vadodara, Gujarat, India

     VMF Others AUDIT
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    03

    Tadalafil

    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 : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37995

    Submission : 2023-02-10

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2014-339 - Rev 03

    Issue Date : 2024-02-14

    Type : Chemical

    Substance Number : 2606

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-11

    Valid Till : 2025-06-26

    Written Confirmation Number : WC-0054

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 59680-018

    Start Marketing Date : 2024-11-30

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Gapi Bio Co., Ltd.

    Registration Date : 2019-10-14

    Registration Number : 20191014-203-I-583-16

    Manufacturer Name : Ami Lifesciences Private Limited

    Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Dist : Vadodara, Gujarat State India

     VMF MX, CN arrow-down
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    Available Reg. Filing : MX, CN
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    04

    Tranexamic Acid

    India

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

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    RDD 2025
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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2023-11-13

    Pay. Date : 2023-11-01

    DMF Number : 36336

    Submission : 2021-10-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2019-250 - Rev 03

    Issue Date : 2025-01-02

    Type : Chemical

    Substance Number : 875

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-11

    Valid Till : 2025-06-26

    Written Confirmation Number : WC-0054

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 59680-012

    Start Marketing Date : 2023-07-14

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Aging Life Science Co., Ltd.

    Registration Date : 2024-10-23

    Registration Number : 20241023-210-J-1706

    Manufacturer Name : Ami Lifesciences Private Limited

    Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Dist : Vadodara, Gujarat State, India

     VMF MX, CN arrow-down
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    05

    Benzonatate

    India

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

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    RDD 2025
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39002

    Submission : 2023-12-04

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-11

    Valid Till : 2025-06-26

    Written Confirmation Number : WC-0054

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    AMI Lifesciences

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    06

    Betahistine Dihydrochloride

    India

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

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    RDD 2025
    Not Confirmed
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2011-101 - Rev 04

    Issue Date : 2024-07-31

    Type : Chemical

    Substance Number : 1665

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-11

    Valid Till : 2025-06-26

    Written Confirmation Number : WC-0054

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Medipoem Co., Ltd.

    Registration Date : 2025-03-14

    Registration Number : 20250205-211-J-1756(1)

    Manufacturer Name : Ami Lifesciences Private Limited

    Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Dist : Vadodara, Gujarat State, India

     VMF MX, CN arrow-down
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    Available Reg. Filing : MX, CN
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    07

    Brivaracetam

    India

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

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    RDD 2025
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36655

    Submission : 2022-01-08

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-11

    Valid Till : 2025-06-26

    Written Confirmation Number : WC-0054

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Aging Life Science Co., Ltd.

    Registration Date : 2023-10-05

    Registration Number : Su434-60-ND

    Manufacturer Name : Ami Lifesciences Private Limited

    Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Dist : Vadodara, Gujarat State, India

     VMF Others AUDIT
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    08

    Desvenlafaxine Succinate

    India

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

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    RDD 2025
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    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38066

    Submission : 2023-03-03

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-11

    Valid Till : 2025-06-26

    Written Confirmation Number : WC-0054

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Aging Life Science Co., Ltd.

    Registration Date : 2021-06-24

    Registration Number : Su434-40-ND

    Manufacturer Name : Ami Lifesciences Private Limited

    Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Dist : Vadodara, Gujarat State India

     VMF CN, MX arrow-down
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    Available Reg. Filing : CN, MX
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    09

    Eslicarbazepine Acetate

    India

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

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    RDD 2025
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    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38309

    Submission : 2023-04-25

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-11

    Valid Till : 2025-06-26

    Written Confirmation Number : WC-0054

    Address of the Firm :

    NDC KDMF VMF ASMF, CN... arrow-down
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    Available Reg. Filing : ASMF, CN, MX
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    10

    Febuxostat

    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 : 37996

    Submission : 2023-02-03

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-11

    Valid Till : 2025-06-26

    Written Confirmation Number : WC-0054

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 59680-016

    Start Marketing Date : 2024-09-14

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    Contact Ami Lifesciences Private Limited and get a quotation

    Ami Lifesciences Private Limited is a supplier offers 81 products (APIs, Excipients or Intermediates).

    Find a price of Ambroxol Hydrochloride bulk with CEP, JDMF, WC offered by Ami Lifesciences Private Limited

    Find a price of Diacerein bulk with DMF, CEP, WC offered by Ami Lifesciences Private Limited

    Find a price of Tadalafil bulk with DMF, CEP, WC offered by Ami Lifesciences Private Limited

    Find a price of Tranexamic Acid bulk with DMF, CEP, WC offered by Ami Lifesciences Private Limited

    Find a price of Benzonatate bulk with DMF, WC offered by Ami Lifesciences Private Limited

    Find a price of Betahistine Dihydrochloride bulk with CEP, WC offered by Ami Lifesciences Private Limited

    Find a price of Brivaracetam bulk with DMF, WC offered by Ami Lifesciences Private Limited

    Find a price of Desvenlafaxine Succinate bulk with DMF, WC offered by Ami Lifesciences Private Limited

    Find a price of Eslicarbazepine Acetate bulk with DMF, WC offered by Ami Lifesciences Private Limited

    Find a price of Febuxostat bulk with DMF, WC offered by Ami Lifesciences Private Limited

    Find a price of Oxcarbazepine bulk with DMF, CEP offered by Ami Lifesciences Private Limited

    Find a price of Rivaroxaban bulk with DMF, CEP offered by Ami Lifesciences Private Limited

    Find a price of Sacubitril-Valsartan bulk with DMF, WC offered by Ami Lifesciences Private Limited

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