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    Ami Lifesciences files Brivaracetam with TGA, expands

    04 Aug 2025

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    Ami Secures Key CEP Approval For Sitagliptin Phosphate Monohydrate

    17 Mar 2025

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    01 3Acebrophylline

    02 1Alpha Lipoic Acid

    03 2Ambroxol Hydrochloride

    04 2Azilsartan

    05 1Bempedoic Acid

    06 10Benfotiamine

    07 1Benserazide Hydrochloride

    08 2Benzonatate

    09 2Betahistine Dihydrochloride

    10 1Bilastine

    11 4Bisbentiamine

    12 2Brivaracetam

    13 1Choline Fenofibrate

    14 1Colesevelam Hydrochloride

    15 1Dapagliflozin

    16 1Dapagliflozin Propanediol Monohydrate

    17 1Dapoxetine Hydrochloride

    18 1Daprodustat

    19 1Deoxycholic Acid

    20 1Desvenlafaxine Benzoate

    21 1Desvenlafaxine Fumarate

    22 1Desvenlafaxine Succinate

    23 1Deucravacitinib

    24 7Diacerein

    25 1Dicyclomine Hydrochloride

    26 3Doxofylline

    27 2Edoxaban Tosylate

    28 1Empagliflozin

    29 1Eslicarbazepine Acetate

    30 1Febuxostat

    31 1Fenofibrate

    32 1Fexofenadine Hydrochloride

    33 1Fezolinetant

    34 3Fimasartan

    35 2Finerenone

    36 1Flavoxate

    37 1Fursultiamine

    38 1Gliclazide

    39 5Itopride Hydrochloride

    40 1Levocloperastine Fendizoate

    41 2Mirabegron

    42 2Mirogabalin Besylate

    43 1Oxcarbazepine

    44 1Pamabrom

    45 1Pemafibrate

    46 1Resmetirom

    47 1Rifaximin

    48 1Rivaroxaban

    49 1Roxadustat

    50 1Sacubitril Sodium

    51 1Sacubitril-Valsartan

    52 1Salcaprozate Sodium

    53 1Semaglutide

    54 1Sevelamer Carbonate

    55 1Sevelamer Hydrochloride

    56 1Sitagliptin Hydrochloride

    57 2Sitagliptin Phosphate

    58 3Tadalafil

    59 1Tapentadol

    60 1Tapentadol Phosphate

    61 2Tegoprazan

    62 1Teneligliptin Hydrobromide

    63 1Timolol Maleate

    64 1Tolvaptan

    65 1Tranexamic Acid

    66 1Trelagliptin Succinate

    67 1Vadadustat

    68 1Vibegron

    69 1Vildagliptin

    70 2Vonoprazan Fumarate

    71 4Blank

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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 : CEP 2023-168 - Rev 01

    Issue Date : 2025-04-28

    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 : 2025-08-05

    Valid Till : 2028-06-25

    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
    ✖
    Available Reg. Filing : CN, MX
    AUDIT arrow-down
    AMI Lifesciences

    02

    Tadalafil

    India

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

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    Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.
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    USDMF arrow-down
    ✖

    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 : 2025-08-05

    Valid Till : 2028-06-25

    Written Confirmation Number : WC-0054

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 59680-018

    Start Marketing Date : 2024-11-30

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Taewang Trading Co., Ltd.

    Registration Date : 2025-10-29

    Registration Number : 20191014-203-I-583-16(B)

    Manufacturer Name : Ami Lifesciences Pvt. Ltd.

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

     VMF BR, CN, ... arrow-down
    ✖
    Available Reg. Filing : BR, CN, MX
    AUDIT arrow-down
    AMI Lifesciences

    03

    Tranexamic Acid

    India

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

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    USDMF arrow-down
    ✖

    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 JDMF arrow-down
    ✖

    Registration Number : 307MF10056

    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 : 2025-04-23

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-05

    Valid Till : 2028-06-25

    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 : 2026-12-31

    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 BR, CN, ... arrow-down
    ✖
    Available Reg. Filing : BR, CN, MX
    AUDIT arrow-down
    AMI Lifesciences

    04

    Benzonatate

    India

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

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    BIO Partnering at JPM
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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 : 2025-08-05

    Valid Till : 2028-06-25

    Written Confirmation Number : WC-0054

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
    AMI Lifesciences

    05

    Betahistine Dihydrochloride

    India

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

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    BIO Partnering at JPM
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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 : 2025-08-05

    Valid Till : 2028-06-25

    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 BR, MX arrow-down
    ✖
    Available Reg. Filing : BR, MX
    AUDIT arrow-down
    AMI Lifesciences

    06

    Brivaracetam

    India

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

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    BIO Partnering at JPM
    Not Confirmed
    • fda
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    Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.
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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 : 2025-08-05

    Valid Till : 2028-06-25

    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 ASMF arrow-down
    ✖
    Available Reg. Filing : ASMF
    AUDIT arrow-down
    AMI Lifesciences

    07

    Desvenlafaxine Succinate

    India

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

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    BIO Partnering at JPM
    Not Confirmed
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    Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.
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    USDMF arrow-down
    ✖

    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 : 2025-08-05

    Valid Till : 2028-06-25

    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 BR, MX arrow-down
    ✖
    Available Reg. Filing : BR, MX
    AUDIT arrow-down
    AMI Lifesciences

    08

    Diacerein

    India

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

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    BIO Partnering at JPM
    Not Confirmed
    • fda
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    Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.
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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 JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-05

    Valid Till : 2028-06-25

    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 : 2026-12-31

    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 CN, MX arrow-down
    ✖
    Available Reg. Filing : CN, MX
    AUDIT arrow-down
    AMI Lifesciences

    09

    Empagliflozin

    India

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

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    BIO Partnering at JPM
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38200

    Submission : 2023-03-29

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-05

    Valid Till : 2028-06-25

    Written Confirmation Number : WC-0054

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Taewang Trading Co., Ltd.

    Registration Date : 2025-09-17

    Registration Number : Su197-1-ND

    Manufacturer Name : Ami Lifesciences Private Limited

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

     VMF Others AUDIT arrow-down
    AMI Lifesciences

    10

    Eslicarbazepine Acetate

    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 : 38309

    Submission : 2023-04-25

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-05

    Valid Till : 2028-06-25

    Written Confirmation Number : WC-0054

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Huseeed Co., Ltd.

    Registration Date : 2025-06-24

    Registration Number : Su928-1-ND

    Manufacturer Name : Ami Lifesciences Private Limited

    Manufacturer Address : Block No. 82/B, ECP Road, At & Post: Karakhadi-391450, Taluka: Padra, District: Vadodara, Gujarat, India

     VMF ASMF, MX arrow-down
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    Available Reg. Filing : ASMF, MX
    AUDIT arrow-down
    AMI Lifesciences
    Contact Ami Lifesciences Private Limited and get a quotation

    Ami Lifesciences Private Limited is a supplier offers 87 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 Tadalafil bulk with DMF, CEP, WC offered by Ami Lifesciences Private Limited

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

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

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

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

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

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

    Find a price of Vildagliptin bulk with JDMF, WC offered by Ami Lifesciences Private Limited

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

    Find a price of Acebrophylline bulk with WC offered by Ami Lifesciences Private Limited

    Find a price of Alpha Lipoic Acid bulk with WC offered by Ami Lifesciences Private Limited

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

    Find a price of Bempedoic Acid bulk with DMF offered by Ami Lifesciences Private Limited

    Find a price of Benfotiamine bulk with WC offered by Ami Lifesciences Private Limited

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

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

    Find a price of Choline Fenofibrate bulk with WC offered by Ami Lifesciences Private Limited

    Find a price of Dapagliflozin bulk with DMF offered by Ami Lifesciences Private Limited

    Find a price of Dapagliflozin Propanediol Monohydrate bulk with DMF offered by Ami Lifesciences Private Limited

    Find a price of Dapoxetine Hydrochloride bulk with WC offered by Ami Lifesciences Private Limited

    Find a price of Daprodustat bulk with DMF offered by Ami Lifesciences Private Limited

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    Find a price of Doxofylline bulk with WC offered by Ami Lifesciences Private Limited

    Find a price of Edoxaban Tosylate bulk with DMF offered by Ami Lifesciences Private Limited

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    Find a price of Gliclazide bulk with CEP offered by Ami Lifesciences Private Limited

    Find a price of Itopride Hydrochloride bulk with WC offered by Ami Lifesciences Private Limited

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    Find a price of Mirabegron bulk with DMF offered by Ami Lifesciences Private Limited

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    Find a price of Tapentadol Phosphate bulk with WC offered by Ami Lifesciences Private Limited

    Find a price of Tegoprazan bulk with DMF offered by Ami Lifesciences Private Limited

    Find a price of Teneligliptin Hydrobromide bulk with WC offered by Ami Lifesciences Private Limited

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    Find a price of Acebrophylline bulk offered by Ami Lifesciences Private Limited

    Find a price of Azilsartan bulk offered by Ami Lifesciences Private Limited

    Find a price of Benfotiamine bulk offered by Ami Lifesciences Private Limited

    Find a price of Benserazide Hydrochloride bulk offered by Ami Lifesciences Private Limited

    Find a price of Betahistine Dihydrochloride bulk offered by Ami Lifesciences Private Limited

    Find a price of Bilastine bulk offered by Ami Lifesciences Private Limited

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    Find a price of Desvenlafaxine Benzoate bulk offered by Ami Lifesciences Private Limited

    Find a price of Desvenlafaxine Fumarate bulk offered by Ami Lifesciences Private Limited

    Find a price of Deucravacitinib bulk offered by Ami Lifesciences Private Limited

    Find a price of Diacerein bulk offered by Ami Lifesciences Private Limited

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