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    Ami Secures Key CEP Approval For Sitagliptin Phosphate Monohydrate

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    01 2Acebrophylline

    02 2Alpha Lipoic Acid

    03 2Ambroxol Hydrochloride

    04 2Azilsartan

    05 1Bempedoic Acid

    06 10Benfotiamine

    07 1Benserazide Hydrochloride

    08 1Benzonatate

    09 2Betahistine Dihydrochloride

    10 1Bilastine

    11 4Bisbentiamine

    12 1Brivaracetam

    13 1Choline Fenofibrate

    14 1Colesevelam Hydrochloride

    15 1Dapagliflozin

    16 1Dapagliflozin Propanediol Monohydrate

    17 1Dapoxetine Hydrochloride

    18 1Daprodustat

    19 1Desvenlafaxine Benzoate

    20 1Desvenlafaxine Fumarate

    21 1Desvenlafaxine Succinate

    22 1Deucravacitinib

    23 7Diacerein

    24 1Dicyclomine Hydrochloride

    25 3Doxofylline

    26 2Edoxaban Tosylate

    27 1Empagliflozin

    28 1Eslicarbazepine Acetate

    29 1Febuxostat

    30 1Fenofibrate

    31 1Fexofenadine Hydrochloride

    32 1Fezolinetant

    33 2Fimasartan

    34 2Finerenone

    35 1Flavoxate

    36 1Fursultiamine

    37 1Gliclazide

    38 5Itopride Hydrochloride

    39 1Levocloperastine Fendizoate

    40 2Mirabegron

    41 2Mirogabalin Besylate

    42 1Oxcarbazepine

    43 1Pamabrom

    44 1Pemafibrate

    45 1Resmetirom

    46 1Rivaroxaban

    47 1Roxadustat

    48 1Sacubitril Sodium

    49 1Sacubitril-Valsartan

    50 1Salcaprozate Sodium

    51 1Sevelamer Carbonate

    52 1Sevelamer Hydrochloride

    53 1Sitagliptin Hydrochloride

    54 2Sitagliptin Phosphate

    55 2Tadalafil

    56 1Tapentadol

    57 1Tapentadol Phosphate

    58 2Tegoprazan

    59 1Teneligliptin Hydrobromide

    60 1Tolvaptan

    61 1Tranexamic Acid

    62 1Trelagliptin Succinate

    63 1Vadadustat

    64 1Vibegron

    65 1Vildagliptin

    66 1Vonoprazan Fumarate

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    01

    Tranexamic Acid

    India

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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
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    Certificate Number : CEP 2019-250 - Rev 03

    Issue Date : 2025-01-02

    Type : Chemical

    Substance Number : 875

    Status : Valid

     JDMF arrow-down
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    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

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    Date of Issue : 2022-08-18

    Valid Till : 2025-06-26

    Written Confirmation Number : WC-0054

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    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

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    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

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    02

    Ambroxol Hydrochloride

    India

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    USDMF CEP/COS arrow-down
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    Certificate Number : CEP 2014-135 - Rev 03

    Issue Date : 2024-03-25

    Type : Chemical

    Substance Number : 1489

    Status : Valid

     JDMF arrow-down
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    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

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    EU-WCInactive-api
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    Date of Issue : 2022-08-18

    Valid Till : 2025-06-26

    Written Confirmation Number : WC-0054

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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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    03

    Diacerein

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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-WCInactive-api
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    Date of Issue : 2022-08-18

    Valid Till : 2025-06-26

    Written Confirmation Number : WC-0054

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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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    04

    Tadalafil

    India

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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
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    Certificate Number : CEP 2014-339 - Rev 03

    Issue Date : 2024-02-14

    Type : Chemical

    Substance Number : 2606

    Status : Valid

     JDMF EU-WCInactive-api
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    Date of Issue : 2022-08-18

    Valid Till : 2025-06-26

    Written Confirmation Number : WC-0054

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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

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    Registrant Name : Hochem Corporation

    Registration Date : 2025-05-19

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

    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

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    05

    Oxcarbazepine

    India

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2025-03-04

    Pay. Date : 2025-01-30

    DMF Number : 38017

    Submission : 2023-03-15

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2022-108 - Rev 02

    Issue Date : 2025-01-30

    Type : Chemical

    Substance Number : 2577

    Status : Valid

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    06

    Rivaroxaban

    India

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37173

    Submission : 2022-06-06

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2022-215 - Rev 01

    Issue Date : 2025-03-12

    Type : Chemical

    Substance Number : 2932

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Pharmapia Co., Ltd.

    Registration Date : 2025-02-13

    Registration Number : Su258-29-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

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    07

    Sitagliptin Phosphate

    India

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37030

    Submission : 2022-05-02

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2022-340 - Rev 00

    Issue Date : 2024-05-06

    Type : Chemical

    Substance Number : 2778

    Status : Valid

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    08

    Sitagliptin Phosphate

    India

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39354

    Submission : 2024-01-20

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2024-249 - Rev 00

    Issue Date : 2024-12-19

    Type : Chemical

    Substance Number : 2778

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    09

    Benzonatate

    India

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39002

    Submission : 2023-12-04

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-08-18

    Valid Till : 2025-06-26

    Written Confirmation Number : WC-0054

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    NDC KDMF VMF Others AUDIT
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    10

    Betahistine Dihydrochloride

    India

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    USDMF CEP/COS arrow-down
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    Certificate Number : CEP 2011-101 - Rev 04

    Issue Date : 2024-07-31

    Type : Chemical

    Substance Number : 1665

    Status : Valid

     JDMF EU-WCInactive-api
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    Date of Issue : 2022-08-18

    Valid Till : 2025-06-26

    Written Confirmation Number : WC-0054

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    NDC KDMF arrow-down
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    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

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    Contact Ami Lifesciences Private Limited and get a quotation

    Ami Lifesciences Private Limited is a supplier offers 73 products (APIs, Excipients or Intermediates).

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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    Find a price of Mirogabalin Besylate bulk with DMF 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 Alpha Lipoic Acid 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 Bilastine bulk offered by Ami Lifesciences Private Limited

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

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

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