menu
    • menu

    Company profile for Ami Lifesciences Private Limited

    AMI-Lifesciences-PSE
    News
    Ami Secures Key CEP Approval For Sitagliptin Phosphate Monohydrate

    17 Mar 2025

    // PRESS RELEASE

    Ami Lifesciences at J.P. Morgan Healthcare Conference 2025

    17 Mar 2025

    // PRESS RELEASE

    Ami is redefining API excellence through precision manufacturing

    17 Mar 2025

    // PRESS RELEASE

    DATA COMPILATION
    #PharmaFlow

    AMI Lifesciences

    Contact Supplier

    Website

    CPhI China

    Booth #E1F57

    Book a meeting

    envelop Contact Supplier

    Latest Content

    radio-compass-blog/excipient-market-overview-roquette-announces-restructuring-post-iff-pharma-buyout-who-fda-advance-regulatory-frameworks

    EVENTS

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    Key Products KEY PRODUCTS

    SERVICES

    EXCIPIENTS

    INSPECTIONS & REGISTRATIONS

    PharmaCompass

    AMI Lifesciences is Driven by Chemistry. Powered by People.

    Related CompaniesRelated Companies

    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.

    CONTACT DETAILS

    Click the arrow to open the dropdown
    Contact SupplierContact
    Google MapGoogle Map
    Full View ScreenFull View Screen
    Ami Lifesciences Private Limitedindia-flag Flag
    Country
    Country
    India
    Address
    Address
    701 to 710, 7th Floor, 1038 Lilleria, Gotri-Sevasi Road, New Alkapuri, Vadodar...
    Telephone
    Telephone
    +91 2652323046
    Client Email
    Email
    info@amilifesciences.com
    Client Website
    Website
    http://amilifesciences.com/
    Linkedin
    Linkedin
    https://www.linkedin.com/company/amilifesciences/
    youtube
    YouTube
    Twitter
    Twitter
    Contact Info
    Others

    Events

    Webinars & Exhibitions

    Request a meetingRequest a meeting
    Full Screen ViewFull Screen View
    Default Event

    CPhI China

    Booth #E1F57

    envelop Contact Supplier

    CPhI China

    Contact Supplier

    Meeting

    Digital content read-more

    Explore the latest content creation from this company

    CORPORATE CONTENT #SupplierSpotlight

    Product List 2025

    read-more

      https://www.pharmacompass.com/pdf/party/content/ami-lifesciences-private-limited-party-content-13735.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    Corporate Presentation

    read-more

      https://www.pharmacompass.com/pdf/party/content/ami-lifesciences-private-limited-party-content-98165.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    GMP Certificate 2019

    read-more

      https://www.pharmacompass.com/pdf/party/content/ami-lifesciences-private-limited-party-content-9928.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    DATA COMPILATION #PharmaFlow

    read-more
    read-more
    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.   
    subscribeSubscribe
    ExcelExcel Download

    Impressions: 7639

    https://www.pharmacompass.com/radio-compass-blog/dmf-filings-hit-all-time-high-in-q3-2024-china-tops-list-with-58-increase-in-type-ii-submissions

    #PharmaFlow by PHARMACOMPASS
    24 Oct 2024
    Share Share

    NEWS #PharmaBuzz

    read-more
    read-more
    Ami Secures Key CEP Approval For Sitagliptin Phosphate Monohydrate
    Ami Secures Key CEP Approval For Sitagliptin Phosphate Monohydrate

    17 Mar 2025

    // PRESS RELEASE

    https://amilifesciences.com/media.php

    PRESS RELEASE
    17 Mar 2025
    Share Share
    Ami Lifesciences at J.P. Morgan Healthcare Conference 2025
    Ami Lifesciences at J.P. Morgan Healthcare Conference 2025

    17 Mar 2025

    // PRESS RELEASE

    https://amilifesciences.com/media.php

    PRESS RELEASE
    17 Mar 2025
    Share Share
    Ami is redefining API excellence through precision manufacturing
    Ami is redefining API excellence through precision manufacturing

    17 Mar 2025

    // PRESS RELEASE

    https://amilifesciences.com/media1.php

    PRESS RELEASE
    17 Mar 2025
    Share Share
    Ami Lifesciences Submits US DMF for Tegoprazan
    Ami Lifesciences Submits US DMF for Tegoprazan

    08 Oct 2024

    // PRESS RELEASE

    https://amilifesciences.com/media.php

    PRESS RELEASE
    08 Oct 2024
    Share Share
    Ami Lifesciences Gets CADIFA Approval for Vonoprazan
    Ami Lifesciences Gets CADIFA Approval for Vonoprazan

    02 Aug 2024

    // PRESS RELEASE

    https://amilifesciences.com/media.php

    PRESS RELEASE
    02 Aug 2024
    Share Share
    Oxcarbazepine Receives CEP Approval from EDQM
    Oxcarbazepine Receives CEP Approval from EDQM

    02 Aug 2024

    // PRESS RELEASE

    https://amilifesciences.com/media.php

    PRESS RELEASE
    02 Aug 2024
    Share Share

    KEY PRODUCTS

    read-more
    read-more
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view

    Services

    Discover the service capabilities from this company

    API Manufacturing

    Discover their expertise for : API Manufacturing

    API & Drug Product Development

    Discover their expertise for : API & Drug Product Development

    Excipients

    Discover the DDS // excipients from this company

    Inspections and registrations

    Check the inspections & registration from this company

    ABOUT THIS PAGE

    Contact Ami Lifesciences Private Limited and get a quotation

    Ami Lifesciences Private Limited is a supplier offers 74 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 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 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

    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 Azilsartan bulk with WC 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 Bilastine bulk with WC 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Find a price of FINERENONE (PROCESS-II) bulk with DMF offered by Ami Lifesciences Private Limited

    Find a price of MIROGABALIN BESYLATE (PROCESS-II) bulk with DMF offered by Ami Lifesciences Private Limited

    Find a price of TEGOPRAZAN (CRYSTALLINE) bulk with DMF offered by Ami Lifesciences Private Limited

    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 Betahistine Dihydrochloride bulk offered by Ami Lifesciences Private Limited

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

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

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

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

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

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

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

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

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

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

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

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

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

    Find a price of Trelagliptin Succinate bulk offered by Ami Lifesciences Private Limited

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

    Find a price of Facebook Start bulk offered by Ami Lifesciences Private Limited

    Find a price of Sea Doo Start bulk offered by Ami Lifesciences Private Limited

    Ask Us for Pharmaceutical Supplier and Partner
    Ask Us, Find A Supplier / Partner
    No Commissions, No Strings Attached, Get Connected for FREE

    What are you looking for?

    How can we help you?

    The request can't be empty

    Please read our Privacy Policy carefully

    You must agree to the privacy policy

    The name can't be empty
    The company can't be empty.
    The email can't be empty Please enter a valid email.
    The mobile can't be empty

    Market Place

    Market Place

    PharmaCompass

    Home

    Market Place

    Menu

    Post Enquiry

    Post Enquiry

    Market Place

    Market Place

    Search