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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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    About

    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.

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    Ami Lifesciences Private Limitedindia-flag Flag
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    701 to 710, 7th Floor, 1038 Lilleria, Gotri-Sevasi Road, New Alkapuri, Vadodar...
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    +91 2652323046
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    info@amilifesciences.com
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    http://amilifesciences.com/
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    Product List 2024

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    Corporate Presentation

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    GMP Certificate 2019

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    DATA COMPILATION #PharmaFlow

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    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   
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    Ami Lifesciences Submits US DMF for Tegoprazan
    Ami Lifesciences Submits US DMF for Tegoprazan

    08 Oct 2024

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    08 Oct 2024
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    Ami Lifesciences Gets CADIFA Approval for Vonoprazan
    Ami Lifesciences Gets CADIFA Approval for Vonoprazan

    02 Aug 2024

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    Oxcarbazepine Receives CEP Approval from EDQM
    Oxcarbazepine Receives CEP Approval from EDQM

    02 Aug 2024

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    02 Aug 2024
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    Ami Have Received Cep Approval For Rivaroxaban,Used An Anti-Coagulating Agent
    Ami Have Received Cep Approval For Rivaroxaban,Used An Anti-Coagulating Agent

    08 Apr 2024

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    08 Apr 2024
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    Ami received CEP approval Gliclazide. With this approval, we're one step closer
    Ami received CEP approval Gliclazide. With this approval, we're one step closer

    01 Mar 2024

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    01 Mar 2024
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    Ami successful filing of the USDMF for Sitagliptin Phosphate Monohydrate
    Ami successful filing of the USDMF for Sitagliptin Phosphate Monohydrate

    23 Jan 2024

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    23 Jan 2024
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    ALL APIs

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    01

    Ambroxol Hydrochloride

    India

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

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    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.
    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
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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

    Latest Date of Registration :

    EU-WCarrow-down
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    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

     VMF CN, MX arrow-down
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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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    USDMF arrow-down
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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 : R1-CEP 2015-173 - Rev 02

    Issue Date : 2022-04-04

    Type : Chemical

    Substance Number : 2409

    Status : Valid

     JDMF EU-WCarrow-down
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    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 : 59680-014

    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
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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

     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
    ✖

    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-WCarrow-down
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    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 : 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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    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
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    Certificate Number : R0-CEP 2019-250 - Rev 02

    Issue Date : 2022-04-04

    Type : Chemical

    Substance Number : 875

    Status : Valid

     JDMF EU-WCarrow-down
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    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 : 59680-012

    Start Marketing Date : 2023-07-14

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF MX, CN arrow-down
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    Available Reg. Filing : MX, CN
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    05

    Brivaracetam

    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 : 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
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    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
    AMI Lifesciences

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    06

    Febuxostat

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

    Product
    Web Link

    Stock Recap
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    07

    Rivaroxaban

    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 : 37173

    Submission : 2022-06-06

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-215 - Rev 00

    Issue Date : 2024-03-28

    Type : Chemical

    Substance Number : 2932

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
    AMI Lifesciences

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    08

    Sacubitril-Valsartan

    India

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

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    Not Confirmed
    • fda
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    Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37994

    Submission : 2023-03-09

    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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

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    09

    Sevelamer Carbonate

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
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    Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37981

    Submission : 2023-01-25

    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 Others AUDIT
    AMI Lifesciences

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
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    10

    Sitagliptin Phosphate

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37030

    Submission : 2022-05-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-340 - Rev 00

    Issue Date : 2024-05-06

    Type : Chemical

    Substance Number : 2778

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
    AMI Lifesciences

    Product
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    Stock Recap
    #PipelineProspector

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    01

    Ambroxol Hydrochloride

    India
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    Ami Lifesciences Private Limited

    Registration Number : 305MF10118

    Registrant's Address : 2nd Floor, Prestige Plaza-40, Urmi Society, Near Urmi Cross Road, BPC Road, Akota, Va...

    Initial Date of Registration : 2023-11-01

    Latest Date of Registration : 2023-11-01

    AMI Lifesciences

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    02

    Vildagliptin

    India
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    Ami Lifesciences Private Limited

    Registration Number : 305MF10086

    Registrant's Address : 2nd Floor, Prestige Plaza-40, Urmi Society, Near Urmi Cross Road, BPC Road, Akota, Va...

    Initial Date of Registration : 2023-07-19

    Latest Date of Registration : 2023-07-19

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    LISTED APIs

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    Acebrophylline

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    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujara...
    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.
    AMI Lifesciences

    01

    Acebrophylline

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    Ami Lifesciences Private Limited

    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.

    About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, ...

    AMI Lifesciences

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    Alpha Lipoic Acid

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    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujara...
    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.
    AMI Lifesciences

    02

    Alpha Lipoic Acid

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    Ami Lifesciences Private Limited

    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.

    About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, ...

    AMI Lifesciences

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    Ambroxol Hydrochloride

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    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujara...
    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.
    AMI Lifesciences

    03

    Ambroxol Hydrochloride

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    Ami Lifesciences Private Limited

    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.

    About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, ...

    AMI Lifesciences

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    Azilsartan

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    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujara...
    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.
    AMI Lifesciences

    04

    Azilsartan

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    Ami Lifesciences Private Limited

    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.

    About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, ...

    AMI Lifesciences

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    Bempedoic Acid

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    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujara...
    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.
    AMI Lifesciences

    05

    Bempedoic Acid

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    Ami Lifesciences Private Limited

    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.

    About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, ...

    AMI Lifesciences

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    Benfotiamine

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    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujara...
    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.
    AMI Lifesciences

    06

    Benfotiamine

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    Ami Lifesciences Private Limited

    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.

    About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, ...

    AMI Lifesciences

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    Benzonatate

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    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujara...
    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.
    AMI Lifesciences

    07

    Benzonatate

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    Ami Lifesciences Private Limited

    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.

    About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, ...

    AMI Lifesciences

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    Betahistine Dihydrochloride

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    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujara...
    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.
    AMI Lifesciences

    08

    Betahistine Dihydrochloride

    India
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    Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

    Ami Lifesciences Private Limited

    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.

    About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, ...

    AMI Lifesciences

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    Bilastine

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    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujara...
    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.
    AMI Lifesciences

    09

    Bilastine

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    Ami Lifesciences Private Limited

    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.

    About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, ...

    AMI Lifesciences

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    Bisbentiamine

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    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujara...
    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.
    AMI Lifesciences

    10

    Bisbentiamine

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    Ami Lifesciences Private Limited

    Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.

    About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, ...

    AMI Lifesciences

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    Contact Ami Lifesciences Private Limited and get a quotation

    Ami Lifesciences Private Limited is a supplier offers 67 products (APIs, Excipients or Intermediates).

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

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