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    Ami Lifesciences Submits US DMF for Tegoprazan

    08 Oct 2024

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    Ami Lifesciences Gets CADIFA Approval for Vonoprazan

    02 Aug 2024

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    Oxcarbazepine Receives CEP Approval from EDQM

    02 Aug 2024

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    01 1Acebrophylline

    02 1Alpha Lipoic Acid

    03 2Ambroxol Hydrochloride

    04 1Azilsartan

    05 1Bempedoic Acid

    06 1Benfotiamine

    07 1Benzonatate

    08 1Betahistine Dihydrochloride

    09 1Bilastine

    10 1Bisbentiamine

    11 1Brivaracetam

    12 1Choline Fenofibrate

    13 1Dapagliflozin

    14 1Dapagliflozin Propanediol Monohydrate

    15 1Dapoxetine Hydrochloride

    16 1Daprodustat

    17 1Desvenlafaxine Succinate

    18 1Deucravacitinib

    19 1Diacerein

    20 1Dicyclomine Hydrochloride

    21 1Doxofylline

    22 1Edoxaban Tosylate

    23 1Empagliflozin

    24 1Eslicarbazepine Acetate

    25 1Febuxostat

    26 1Fenofibrate

    27 1Fexofenadine Hydrochloride

    28 1Fimasartan

    29 1Finerenone

    30 1Flavoxate

    31 1Fursultiamine

    32 1Gliclazide

    33 1Imeglimin Hydrochloride

    34 1Itopride Hydrochloride

    35 1Levocloperastine Fendizoate

    36 1Mirabegron

    37 1Mirogabalin Besylate

    38 1Obeticholic Acid

    39 1Oxcarbazepine

    40 1Pamabrom

    41 1Pemafibrate

    42 1Resmetirom

    43 1Rivaroxaban

    44 1Roxadustat

    45 1Rutin

    46 1Sacubitril Sodium

    47 1Sacubitril-Valsartan

    48 1Salcaprozate Sodium

    49 1Sevelamer Carbonate

    50 1Sevelamer Hydrochloride

    51 1Sitagliptin Hydrochloride

    52 2Sitagliptin Phosphate

    53 1Tadalafil

    54 1Tapentadol

    55 1Tapentadol Phosphate

    56 1Tegoprazan

    57 1Teneligliptin Hydrobromide

    58 1Tranexamic Acid

    59 1Trelagliptin Succinate

    60 1Vadadustat

    61 1Venlafaxine Hydrochloride

    62 1Vibegron

    63 1Vildagliptin

    64 1Vonoprazan Fumarate

    65 1Xanthinol Nicotinate

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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
    ✖

    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
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    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

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    Available Reg. Filing : CN, MX
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    02

    Diacerein

    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 : 38766

    Submission : 2023-09-15

    Status : Active

    Type : II

     CEP/COS arrow-down
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    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 :

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    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

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    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

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