menu
    • menu

    List of Drug Master Files (JDMF) of Active Pharmaceutical Ingredients (APIs) submitted by Megafine Pharma (P) Limited to the Review Authority in Japan (PMDA). Original Data : PMDA

    Megafine-PSE
    News
    USFDA issues warning letter to Megafine Pharma

    01 Jun 2016

    // ECONOMICTIMES

    BMS pays Prime $110M to form T-cell therapy pact

    01 Oct 2024

    // PRESS RELEASE

    Pfizer to sell about $3.25 bln stake in Sensodyne-maker Haleon

    01 Oct 2024

    // Shanima A REUTERS

    DATA COMPILATION
    #PharmaFlow

    Megafine Pharma

    Contact Supplier

    Website

    CPhI Worldwide, Milan

    Attending

    Book a meeting

    envelop Contact Supplier

    Latest Content by PharmaCompass

    speak-pharma/ice-is-pioneering-sustainability-innovation-in-bile-acid-research-for-neurodegenerative-diseases

    EVENTS

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    Key Products KEY PRODUCTS

    INSPECTIONS & REGISTRATIONS

    PharmaCompass

    Megafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Related CompaniesRelated Companies

    About

    Megafine, established in 1995, is a privately owned and professionally managed enterprise with its corporate office in MUMBAI and two multipurpose manufacturing sites at VAPI & NASHIK in India for APIs & Intermediates. The facilities have been successfully inspected by US-FDA, EDQM, Japan PMDA, Health Canada, TGA Australia, ANVISA Brazil, COFEPRIS Mexico, Korea MFDS & WHO besides being certified for ISO 9001:2008, 14001:2004 & OHSAS 18001:2007. The company focuses on niche molecules for the regulated market globally.

    CONTACT DETAILS

    Click the arrow to open the dropdown
    Contact SupplierContact
    Google MapGoogle Map
    Full View ScreenFull View Screen
    Megafine Pharma (P) Limitedindia-flag Flag
    Country
    Country
    India
    Address
    Address
    Sethna 4th floor, 55 Maharshi Karve Road, Marine Lines, Mumbai – 400 002 Mah...
    Telephone
    Telephone
    +91 22 61461111
    Client Email
    Email
    info@megafine.in
    Client Website
    Website
    http://megafine.in/
    Linkedin
    Linkedin
    https://www.linkedin.com/company/megafine-pharma-p-ltd-/?originalSubdomain=in
    youtube
    YouTube
    Twitter
    Twitter
    https://twitter.com/MegafinePharma
    Contact Info
    Others

    Nashik Site
    Plot No. 1 to 5, 31 to 35, 48 to 51, 26 & K/201,
    Lakhmapur, Tal. Dindori, Dist. Nashik - 422 202,
    Maharashtra, INDIA

    Vapi Site
    911 & 912, III Phase GIDC,
    Vapi – 396195 Gujarat, INDIA

    Events

    Webinars & Exhibitions

    Request a meetingRequest a meeting
    Full Screen ViewFull Screen View
    cphi-worldwide-milan-70313.png

    CPhI Worldwide, Milan

    Attending

    envelop Contact Supplier

    CPhI Worldwide, Milan

    Contact Supplier

    Meeting

    Digital content read-more

    Explore the latest content creation from this company

    CORPORATE CONTENT #SupplierSpotlight

    Product List 2023

    read-more

      https://www.pharmacompass.com/pdf/party/content/megafine-pharma-p-limited-party-content-81041.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    APIs Under Development 2023

    read-more

      https://www.pharmacompass.com/pdf/party/content/megafine-pharma-p-limited-party-content-90105.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    GMP Certificate (Vapi) 2023

    read-more

      https://www.pharmacompass.com/pdf/party/content/megafine-pharma-p-limited-party-content-66473.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    GMP Certificate (Nashik) 2023

    read-more

      https://www.pharmacompass.com/pdf/party/content/megafine-pharma-party-content-11447.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    NEWS #PharmaBuzz

    read-more
    read-more
    USFDA issues warning letter to Megafine Pharma
    USFDA issues warning letter to Megafine Pharma

    01 Jun 2016

    // ECONOMICTIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/usfda-issues-warning-letter-to-megafine-pharma/articleshow/52539066.cms?from=mdr

    ECONOMICTIMES
    01 Jun 2016
    Share Share

    ALL APIs

    read-moreClick the button for full data set
    read-moreClick the button for full data set

    01

    Donepezil

    India

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

    arrow
    CPhI Worldwide, Milan
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-10-07

    Pay. Date : 2013-09-26

    DMF Number : 22379

    Submission : 2008-12-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2021-494 - Rev 00

    Issue Date : 2024-02-22

    Type : Chemical

    Substance Number : 2582

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10164

    Registrant's Address : Sethna 4th floor 55 Maharshi karve road Marine Lines,Mumbai-400002,INDIA

    Initial Date of Registration : 2010-06-04

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2023-06-26

    Valid Till : 2026-06-26

    Written Confirmation Number : WC-0462

    Address of the Firm :

    NDC KDMF VMF CA, AU, ... arrow-down
    ✖
    Available Reg. Filing : CA, AU, BR, CN, RU
    AUDIT
    Megafine Pharma

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Pyrantel Pamoate

    India

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

    arrow
    CPhI Worldwide, Milan
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20613

    Submission : 2007-06-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2006-162 - Rev 02

    Issue Date : 2023-02-15

    Type : Chemical

    Substance Number : 1680

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 221MF10046

    Registrant's Address : Sethna 4th floor 55 Maharshi karve road Marine Lines,Mumbai-400002,INDIA

    Initial Date of Registration : 2009-02-25

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-27

    Valid Till : 2025-07-21

    Written Confirmation Number : WC-0087-(Annexure-1)

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22665-0002

    Start Marketing Date : 2010-07-19

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF CA, CN, ... arrow-down
    ✖
    Available Reg. Filing : CA, CN, RU
    AUDIT
    Megafine Pharma

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Bosentan Hydrate

    India

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

    arrow
    CPhI Worldwide, Milan
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-08-20

    Pay. Date : 2013-09-26

    DMF Number : 25354

    Submission : 2011-09-30

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 227MF10202

    Registrant's Address : Sethna 4th floor 55 Maharshi karve road Marine Lines,Mumbai-400002,INDIA

    Initial Date of Registration : 2015-08-06

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-27

    Valid Till : 2025-07-21

    Written Confirmation Number : WC-0087-(Annexure-1)

    Address of the Firm :

    NDC KDMF VMF ASMF, CA... arrow-down
    ✖
    Available Reg. Filing : ASMF, CA, AU, BR, CN
    AUDIT
    Megafine Pharma

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    Mirtazapine

    India

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

    arrow
    CPhI Worldwide, Milan
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20570

    Submission : 2007-05-28

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2008-214 - Rev 03

    Issue Date : 2023-01-25

    Type : Chemical

    Substance Number : 2338

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-27

    Valid Till : 2025-07-21

    Written Confirmation Number : WC-0087-(Annexure-1)

    Address of the Firm :

    NDC KDMF VMF CA, AU, ... arrow-down
    ✖
    Available Reg. Filing : CA, AU, BR, MX
    AUDIT
    Megafine Pharma

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Quetiapine Hemifumarate

    India

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

    arrow
    CPhI Worldwide, Milan
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-01-22

    Pay. Date : 2013-09-26

    DMF Number : 22744

    Submission : 2009-04-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2014-198 - Rev 01

    Issue Date : 2023-11-21

    Type : Chemical

    Substance Number : 2541

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-06-26

    Valid Till : 2026-06-26

    Written Confirmation Number : WC-0462

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : IMCD Korea Co., Ltd.

    Registration Date : 2013-09-17

    Registration Number : 20130917-172-I-326-12

    Manufacturer Name : Megafine Pharma (P) Ltd.

    Manufacturer Address : Plot No. 1 to 5, 31 to 35 & 48 to 51, 26 & K/201, Lakhmapur, Tal. Dindori, Dist. Nashik-422202, Maharashtra, India

     VMF RU arrow-down
    ✖
    Available Reg. Filing : RU
    AUDIT
    Megafine Pharma

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Rivaroxaban

    India

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

    arrow
    CPhI Worldwide, Milan
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-06-10

    Pay. Date : 2015-01-16

    DMF Number : 28927

    Submission : 2014-12-10

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2021-277 - Rev 01

    Issue Date : 2023-08-07

    Type : Chemical

    Substance Number : 2932

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-06-26

    Valid Till : 2026-06-26

    Written Confirmation Number : WC-0462

    Address of the Firm :

    NDC KDMF VMF AU, BR, ... arrow-down
    ✖
    Available Reg. Filing : AU, BR, CN
    AUDIT
    Megafine Pharma

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Solifenacin Succinate

    India

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

    arrow
    CPhI Worldwide, Milan
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-09-11

    Pay. Date : 2013-01-07

    DMF Number : 24186

    Submission : 2010-09-10

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-149 - Rev 00

    Issue Date : 2022-03-17

    Type : Chemical

    Substance Number : 2779

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-27

    Valid Till : 2025-07-21

    Written Confirmation Number : WC-0087-(Annexure-1)

    Address of the Firm :

    NDC KDMF VMF CA, AU, ... arrow-down
    ✖
    Available Reg. Filing : CA, AU, BR, RU
    AUDIT
    Megafine Pharma

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Teriflunomide

    India

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

    arrow
    CPhI Worldwide, Milan
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-02-05

    Pay. Date : 2015-09-24

    DMF Number : 29802

    Submission : 2015-09-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-418 - Rev 00

    Issue Date : 2024-09-02

    Type : Chemical

    Substance Number : 3036

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-27

    Valid Till : 2025-07-21

    Written Confirmation Number : WC-0087-(Annexure-1)

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    Megafine Pharma

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Venlafaxine Hydrochloride

    India

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

    arrow
    CPhI Worldwide, Milan
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-05-04

    Pay. Date : 2015-04-09

    DMF Number : 23102

    Submission : 2009-09-04

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2009-023 - Rev 02

    Issue Date : 2022-06-13

    Type : Chemical

    Substance Number : 2119

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-27

    Valid Till : 2025-07-21

    Written Confirmation Number : WC-0087-(Annexure-1)

    Address of the Firm :

    NDC KDMF VMF CA, MX arrow-down
    ✖
    Available Reg. Filing : CA, MX
    AUDIT
    Megafine Pharma

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Ziprasidone Hydrochloride

    India

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

    arrow
    CPhI Worldwide, Milan
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23739

    Submission : 2010-04-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2011-141 - Rev 00

    Issue Date : 2018-02-09

    Type : Chemical

    Substance Number : 2421

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-27

    Valid Till : 2025-07-21

    Written Confirmation Number : WC-0087-(Annexure-1)

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    Megafine Pharma

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    Only 10 entries up to this point, click to access all click full view read-more
    click full view
    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    KEY PRODUCTS

    read-more
    read-more

    TOP RANKED SUPPLIER FOR:

    Sponsored Ads.
    full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view

    Inspections and registrations

    Check the inspections & registration from this company

    Others

    read-more
    read-more

    ABOUT THIS PAGE

    Contact Megafine Pharma (P) Limited and get a quotation

    Megafine Pharma (P) Limited is a supplier offers 39 products (APIs, Excipients or Intermediates).

    Find a price of Donepezil bulk with DMF, CEP, JDMF, WC offered by Megafine Pharma (P) Limited

    Find a price of Pyrantel Pamoate bulk with DMF, CEP, JDMF, WC offered by Megafine Pharma (P) Limited

    Find a price of Bosentan Hydrate bulk with DMF, JDMF, WC offered by Megafine Pharma (P) Limited

    Find a price of Mirtazapine bulk with DMF, CEP, WC offered by Megafine Pharma (P) Limited

    Find a price of Quetiapine Hemifumarate bulk with DMF, CEP, WC offered by Megafine Pharma (P) Limited

    Find a price of Rivaroxaban bulk with DMF, CEP, WC offered by Megafine Pharma (P) Limited

    Find a price of Solifenacin Succinate bulk with DMF, CEP, WC offered by Megafine Pharma (P) Limited

    Find a price of Teriflunomide bulk with DMF, CEP, WC offered by Megafine Pharma (P) Limited

    Find a price of Venlafaxine Hydrochloride bulk with DMF, CEP, WC offered by Megafine Pharma (P) Limited

    Find a price of Ziprasidone Hydrochloride bulk with DMF, CEP, WC offered by Megafine Pharma (P) Limited

    Find a price of Ambrisentan bulk with DMF, WC offered by Megafine Pharma (P) Limited

    Find a price of Asenapine Maleate bulk with DMF, WC offered by Megafine Pharma (P) Limited

    Find a price of Cinacalcet Hydrochloride bulk with DMF, WC offered by Megafine Pharma (P) Limited

    Find a price of Darifenacin Hydrobromide bulk with DMF, WC offered by Megafine Pharma (P) Limited

    Find a price of Memantine Hydrochloride bulk with DMF, WC offered by Megafine Pharma (P) Limited

    Find a price of Mirabegron bulk with DMF, WC offered by Megafine Pharma (P) Limited

    Find a price of Paliperidone bulk with DMF, WC offered by Megafine Pharma (P) Limited

    Find a price of Prasugrel Hydrochloride bulk with DMF, WC offered by Megafine Pharma (P) Limited

    Find a price of Apixaban bulk with WC offered by Megafine Pharma (P) Limited

    Find a price of Apremilast bulk with WC offered by Megafine Pharma (P) Limited

    Find a price of Desvenlafaxine Succinate bulk with WC offered by Megafine Pharma (P) Limited

    Find a price of Donepezil bulk with WC offered by Megafine Pharma (P) Limited

    Find a price of Lurasidone Hydrochloride bulk with WC offered by Megafine Pharma (P) Limited

    Find a price of Memantine Hydrochloride bulk with WC offered by Megafine Pharma (P) Limited

    Find a price of Mirtazapine bulk with DMF offered by Megafine Pharma (P) Limited

    Find a price of Quetiapine Hemifumarate bulk with WC offered by Megafine Pharma (P) Limited

    Find a price of Rivaroxaban bulk with WC offered by Megafine Pharma (P) Limited

    Find a price of Vildagliptin bulk with WC offered by Megafine Pharma (P) Limited

    Find a price of Vortioxetine Hydrobromide bulk with WC offered by Megafine Pharma (P) Limited

    Find a price of Cariprazine Hydrochloride bulk offered by Megafine Pharma (P) Limited

    Find a price of Dabigatran Etexilate Mesylate bulk offered by Megafine Pharma (P) Limited

    Find a price of Edoxaban Tosylate bulk offered by Megafine Pharma (P) Limited

    Find a price of Macitentan bulk offered by Megafine Pharma (P) Limited

    Find a price of Morantel Citrate bulk offered by Megafine Pharma (P) Limited

    Find a price of Morantel Tartrate bulk offered by Megafine Pharma (P) Limited

    Find a price of Oxantel Pamoate bulk offered by Megafine Pharma (P) Limited

    Find a price of Pyrantel Tartrate bulk offered by Megafine Pharma (P) Limited

    Find a price of Riociguat bulk offered by Megafine Pharma (P) Limited

    Find a price of Selexipag bulk offered by Megafine Pharma (P) 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