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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Megafine Pharma (P) Limited

    Client Virtual Booth

    MEGAFINE PHARMA (P) LIMITED

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    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

    Key Products KEY PRODUCTS

    • Apremilast

    • Cariprazine Hydrochloride

    • Edoxaban Tosylate

    • Solifenacin Succinate

    • Vortioxetine Hydrobromide

    INSPECTIONS & REGISTRATIONS

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    Megafine Pharma VB RMU
    Megafine Pharma (P) Limited
    india-flag Flag
    Country
    Country
    India
    Address
    Address
    Sethna 4th floor, 55 Maharshi Karve Road, Marine Lines, Mumbai – 400 002 Maharashtra
    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
    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

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    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Donepezil

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    USDMF

    Found USDMF

    22379
    Active
    DONEPEZIL HYDROCHLORIDE USP (NON-ST...
    2008-12-25
    CEP/COS

    Found CEP/COS

    CEP 2021-494 - Rev 00
    Valid
    Donepezil hydrochloride, Monohydrat...
    2024-02-22
    Japanese DMF

    Found JDMF

    222MF10164
    Donepezil Hydrochloride at Sethna 4...
    2010-06-04
    Written Confirmation

    Found WC

    Indian CDSCO WC-0462
    Valid
    Donepezil HCl USP/IP/IHS
    2023-06-26
    Application Number
    22379
    CEP 2021-494 - Rev 00
    222MF10164
    Indian CDSCO WC-0462
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2026-06-26
    Filing Details
    DONEPEZIL HYDROCHLORIDE USP (NON-ST...
    Donepezil hydrochloride, Monohydrat...
    Donepezil Hydrochloride at Sethna 4...
    Donepezil HCl USP/IP/IHS
    Issue/Submission Date
    2008-12-25
    2024-02-22
    2010-06-04
    2023-06-26
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Pyrantel Pamoate

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    USDMF

    Found USDMF

    20613
    Active
    PYRANTEL PAMOATE USP (NON STERILE D...
    2007-06-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-162 - Rev 02
    Valid
    Pyrantel embonate
    2023-02-15
    Japanese DMF

    Found JDMF

    221MF10046
    Piranterupamo salt (production only...
    2009-02-25
    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-1)
    Valid
    Pyrantel Pamoate/ Pyrantel Embonate...
    2022-07-27
    Application Number
    20613
    R1-CEP 2006-162 - Rev 02
    221MF10046
    Indian CDSCO WC-0087-(Annexure-1)
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-21
    Filing Details
    PYRANTEL PAMOATE USP (NON STERILE D...
    Pyrantel embonate
    Piranterupamo salt (production only...
    Pyrantel Pamoate/ Pyrantel Embonate...
    Issue/Submission Date
    2007-06-15
    2023-02-15
    2009-02-25
    2022-07-27
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Bosentan Hydrate

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    USDMF

    Found USDMF

    25354
    Active
    BOSENTAN MONOHYDRATE (NON-STERILE D...
    2011-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10202
    Bosentan hydrate at Sethna 4th floo...
    2015-08-06
    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-1)
    Valid
    Bosentan Monohydrate IH
    2022-07-27
    Application Number
    25354
    227MF10202
    Indian CDSCO WC-0087-(Annexure-1)
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-21
    Filing Details
    BOSENTAN MONOHYDRATE (NON-STERILE D...
    Bosentan hydrate at Sethna 4th floo...
    Bosentan Monohydrate IH
    Issue/Submission Date
    2011-09-30
    2015-08-06
    2022-07-27
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Mirtazapine

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    USDMF

    Found USDMF

    20570
    Active
    MIRTAZAPINE ANHYDROUS USP (NON-STER...
    2007-05-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-214 - Rev 03
    Valid
    Mirtazapine, Hemihydrate
    2023-01-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-1)
    Valid
    Mirtazapine IP/USP/EP / Mirtazapine...
    2022-07-27
    Application Number
    20570
    R1-CEP 2008-214 - Rev 03
    Indian CDSCO WC-0087-(Annexure-1)
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-21
    Filing Details
    MIRTAZAPINE ANHYDROUS USP (NON-STER...
    Mirtazapine, Hemihydrate
    Mirtazapine IP/USP/EP / Mirtazapine...
    Issue/Submission Date
    2007-05-28
    2023-01-25
    2022-07-27
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Quetiapine Hemifumarate

    PDF Supplier PDF
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    Other DMF RU
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    See Less

    USDMF

    Found USDMF

    22744
    Active
    QUETIAPINE HEMIFUMARATE USP
    2009-04-20
    CEP/COS

    Found CEP/COS

    CEP 2014-198 - Rev 01
    Valid
    Quetiapine Fumarate
    2023-11-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0462
    Valid
    Quetiapine Fumarate USP/IP/Ph.Eur/I...
    2023-06-26
    Application Number
    22744
    CEP 2014-198 - Rev 01
    Indian CDSCO WC-0462
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2026-06-26
    Filing Details
    QUETIAPINE HEMIFUMARATE USP
    Quetiapine Fumarate
    Quetiapine Fumarate USP/IP/Ph.Eur/I...
    Issue/Submission Date
    2009-04-20
    2023-11-21
    2023-06-26
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Rivaroxaban

    PDF Supplier PDF
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    USDMF

    Found USDMF

    28927
    Active
    RIVAROXABAN (NON-STERILE DRUG SUBST...
    2014-12-10
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-277 - Rev 01
    Valid
    Rivaroxaban
    2023-08-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0462
    Valid
    Rivaroxaban IH
    2023-06-26
    Application Number
    28927
    R0-CEP 2021-277 - Rev 01
    Indian CDSCO WC-0462
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2026-06-26
    Filing Details
    RIVAROXABAN (NON-STERILE DRUG SUBST...
    Rivaroxaban
    Rivaroxaban IH
    Issue/Submission Date
    2014-12-10
    2023-08-07
    2023-06-26
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Solifenacin Succinate

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    USDMF

    Found USDMF

    24186
    Active
    SOLIFENACIN SUCCINATE
    2010-09-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-149 - Rev 00
    Valid
    Solifenacin succinate
    2022-03-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-1)
    Valid
    Solifenacin Succinate IH/EP
    2022-07-27
    Application Number
    24186
    R1-CEP 2016-149 - Rev 00
    Indian CDSCO WC-0087-(Annexure-1)
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-21
    Filing Details
    SOLIFENACIN SUCCINATE
    Solifenacin succinate
    Solifenacin Succinate IH/EP
    Issue/Submission Date
    2010-09-10
    2022-03-17
    2022-07-27
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Venlafaxine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF CA, MX
    See all info for this product

    See Less

    USDMF

    Found USDMF

    23102
    Active
    VENLAFAXINE HYDROCHLORIDE USP
    2009-09-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-023 - Rev 02
    Valid
    Venlafaxine hydrochloride
    2022-06-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-1)
    Valid
    Venlafaxine Hydrochloride USP/EP
    2022-07-27
    Application Number
    23102
    R1-CEP 2009-023 - Rev 02
    Indian CDSCO WC-0087-(Annexure-1)
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-21
    Filing Details
    VENLAFAXINE HYDROCHLORIDE USP
    Venlafaxine hydrochloride
    Venlafaxine Hydrochloride USP/EP
    Issue/Submission Date
    2009-09-04
    2022-06-13
    2022-07-27
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Ziprasidone Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    23739
    Active
    ZIPRASIDONE HYDROCHLORIDE MONOHYDRA...
    2010-04-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-141 - Rev 00
    Valid
    Ziprasidone hydrochloride monohydra...
    2018-02-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-1)
    Valid
    Ziprasidone Hydrochloride Monohydra...
    2022-07-27
    Application Number
    23739
    R1-CEP 2011-141 - Rev 00
    Indian CDSCO WC-0087-(Annexure-1)
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-21
    Filing Details
    ZIPRASIDONE HYDROCHLORIDE MONOHYDRA...
    Ziprasidone hydrochloride monohydra...
    Ziprasidone Hydrochloride Monohydra...
    Issue/Submission Date
    2010-04-21
    2018-02-09
    2022-07-27
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Ambrisentan

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF CN, RU, EU
    See all info for this product

    See Less

    USDMF

    Found USDMF

    29792
    Active
    AMBRISENTAN
    2015-09-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-1)
    Valid
    Ambrisentan IH
    2022-07-27
    Application Number
    29792
    Indian CDSCO WC-0087-(Annexure-1)
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-21
    Filing Details
    AMBRISENTAN
    Ambrisentan IH
    Issue/Submission Date
    2015-09-09
    2022-07-27
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Asenapine Maleate

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    27292
    Active
    ASENAPINE MALEATE (NON-STERILE DRUG...
    2013-06-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-1)
    Valid
    Asenapine Maleate IH
    2022-07-27
    Application Number
    27292
    Indian CDSCO WC-0087-(Annexure-1)
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-21
    Filing Details
    ASENAPINE MALEATE (NON-STERILE DRUG...
    Asenapine Maleate IH
    Issue/Submission Date
    2013-06-30
    2022-07-27
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Cinacalcet Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, CA, AU, BR, CN
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    See Less

    USDMF

    Found USDMF

    24881
    Active
    CINACALCET HYDROCHLORIDE (NON-STERI...
    2011-04-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-1)
    Valid
    Cinacalcet Hydrochloride IH
    2022-07-27
    Application Number
    24881
    Indian CDSCO WC-0087-(Annexure-1)
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-21
    Filing Details
    CINACALCET HYDROCHLORIDE (NON-STERI...
    Cinacalcet Hydrochloride IH
    Issue/Submission Date
    2011-04-22
    2022-07-27
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Darifenacin Hydrobromide

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, BR
    See all info for this product

    See Less

    USDMF

    Found USDMF

    26533
    Active
    DARIFENACIN HYDROBROMIDE (NON STERI...
    2012-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-1)
    Valid
    Darifenacin Hydrobromide IH
    2022-07-27
    Application Number
    26533
    Indian CDSCO WC-0087-(Annexure-1)
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-21
    Filing Details
    DARIFENACIN HYDROBROMIDE (NON STERI...
    Darifenacin Hydrobromide IH
    Issue/Submission Date
    2012-09-30
    2022-07-27
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Memantine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, CA, BR, MX, CN, RU
    See all info for this product

    See Less

    USDMF

    Found USDMF

    25402
    Active
    MEMANTINE HYDROCHLORIDE USP
    2011-10-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0462
    Valid
    Memantine Hydrochloride IP/USP
    2023-06-26
    Application Number
    25402
    Indian CDSCO WC-0462
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2026-06-26
    Filing Details
    MEMANTINE HYDROCHLORIDE USP
    Memantine Hydrochloride IP/USP
    Issue/Submission Date
    2011-10-14
    2023-06-26
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Mirabegron

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, BR, CN
    See all info for this product

    See Less

    USDMF

    Found USDMF

    29773
    Active
    MIRABEGRON DRUG SUBSTANCE
    2015-09-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-1)
    Valid
    Mirabegron IH
    2022-07-27
    Application Number
    29773
    Indian CDSCO WC-0087-(Annexure-1)
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-21
    Filing Details
    MIRABEGRON DRUG SUBSTANCE
    Mirabegron IH
    Issue/Submission Date
    2015-09-25
    2022-07-27
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Paliperidone

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    25642
    Active
    PALIPERIDONE USP (NON- STERILE DRUG...
    2011-12-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-1)
    Valid
    Paliperidone IH
    2022-07-27
    Application Number
    25642
    Indian CDSCO WC-0087-(Annexure-1)
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-21
    Filing Details
    PALIPERIDONE USP (NON- STERILE DRUG...
    Paliperidone IH
    Issue/Submission Date
    2011-12-28
    2022-07-27
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Prasugrel Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    29678
    Active
    PRASUGREL HYDROCHLORIDE
    2015-08-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-1)
    Valid
    Prasugrel Hydrochloride IH
    2022-07-27
    Application Number
    29678
    Indian CDSCO WC-0087-(Annexure-1)
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-21
    Filing Details
    PRASUGREL HYDROCHLORIDE
    Prasugrel Hydrochloride IH
    Issue/Submission Date
    2015-08-14
    2022-07-27
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Teriflunomide

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    29802
    Active
    TERIFLUNOMIDE DRUG SUBSTANCE
    2015-09-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-1)
    Valid
    Teriflunomide IH
    2022-07-27
    Application Number
    29802
    Indian CDSCO WC-0087-(Annexure-1)
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-21
    Filing Details
    TERIFLUNOMIDE DRUG SUBSTANCE
    Teriflunomide IH
    Issue/Submission Date
    2015-09-29
    2022-07-27
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

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

    Apixaban

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-1)
    Valid
    Apixaban IH
    2022-07-27
    Application Number
    Indian CDSCO WC-0087-(Annexure-1)
    Status
     
    Valid
    2025-07-21
    Filing Details
    Apixaban IH
    Issue/Submission Date
    2022-07-27
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

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    • FDA
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    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Apremilast

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-2)
    Valid
    Apremilast IHS
    2023-08-28
    Application Number
    Indian CDSCO WC-0087-(Annexure-2)
    Status
     
    Valid
    2025-07-21
    Filing Details
    Apremilast IHS
    Issue/Submission Date
    2023-08-28
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

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    • FDA
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    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Desvenlafaxine Succinate

    PDF Supplier PDF
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    Other DMF BR, CN
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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-1)
    Valid
    Desvenlafaxine Succinate Monohydrat...
    2022-07-27
    Application Number
    Indian CDSCO WC-0087-(Annexure-1)
    Status
     
    Valid
    2025-07-21
    Filing Details
    Desvenlafaxine Succinate Monohydrat...
    Issue/Submission Date
    2022-07-27
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
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    • FDA
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    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Donepezil

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    Other DMF CA, AU, BR, CN
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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-1)
    Valid
    Donepezil Hydrochloride (Form I) IH...
    2022-07-27
    Application Number
    Indian CDSCO WC-0087-(Annexure-1)
    Status
     
    Valid
    2025-07-21
    Filing Details
    Donepezil Hydrochloride (Form I) IH...
    Issue/Submission Date
    2022-07-27
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

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    • FDA
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    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Lurasidone Hydrochloride

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-1)
    Valid
    Lurasidone Hydrochloride IH
    2022-07-27
    Application Number
    Indian CDSCO WC-0087-(Annexure-1)
    Status
     
    Valid
    2025-07-21
    Filing Details
    Lurasidone Hydrochloride IH
    Issue/Submission Date
    2022-07-27
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
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    • FDA
    • EDQM
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    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Memantine Hydrochloride

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    URL Supplier Web Content
    Other DMF EU, CA, BR, MX, CN, RU
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-1)
    Valid
    Memantine Hydrochloride IH/USP
    2022-07-27
    Application Number
    Indian CDSCO WC-0087-(Annexure-1)
    Status
     
    Valid
    2025-07-21
    Filing Details
    Memantine Hydrochloride IH/USP
    Issue/Submission Date
    2022-07-27
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

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    • FDA
    • EDQM
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    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Mirtazapine

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    Other DMF CA, AU, BR, MX
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    USDMF

    Found USDMF

    23003
    Active
    MIRTAZAPINE HEMIHYDRATE USP (NON ST...
    2009-07-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23003
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MIRTAZAPINE HEMIHYDRATE USP (NON ST...
    Issue/Submission Date
    2009-07-30
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
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    • FDA
    • EDQM
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    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Quetiapine Hemifumarate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF RU
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-1)
    Valid
    Quetiapine Hemifumarate IH/EP/USP
    2022-07-27
    Application Number
    Indian CDSCO WC-0087-(Annexure-1)
    Status
     
    Valid
    2025-07-21
    Filing Details
    Quetiapine Hemifumarate IH/EP/USP
    Issue/Submission Date
    2022-07-27
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Rivaroxaban

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF AU, BR, CN
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-1)
    Valid
    Rivaroxaban IH
    2022-07-27
    Application Number
    Indian CDSCO WC-0087-(Annexure-1)
    Status
     
    Valid
    2025-07-21
    Filing Details
    Rivaroxaban IH
    Issue/Submission Date
    2022-07-27
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
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    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Vildagliptin

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    Other DMF BR, RU
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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0462
    Valid
    Vildagliptin IH
    2023-06-26
    Application Number
    Indian CDSCO WC-0462
    Status
     
    Valid
    2026-06-26
    Filing Details
    Vildagliptin IH
    Issue/Submission Date
    2023-06-26
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
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    • FDA
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    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Vildagliptin

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    URL Supplier Web Content
    Other DMF BR, RU
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-1)
    Valid
    Vildagliptin IH
    2022-07-27
    Application Number
    Indian CDSCO WC-0087-(Annexure-1)
    Status
     
    Valid
    2025-07-21
    Filing Details
    Vildagliptin IH
    Issue/Submission Date
    2022-07-27
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Vortioxetine Hydrobromide

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0087-(Annexure-2)
    Valid
    Vortioxetine Hydrobromide IHS
    2023-08-28
    Application Number
    Indian CDSCO WC-0087-(Annexure-2)
    Status
     
    Valid
    2025-07-21
    Filing Details
    Vortioxetine Hydrobromide IHS
    Issue/Submission Date
    2023-08-28
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
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    • FDA
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    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Cariprazine Hydrochloride

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
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    • Audit Compliance
    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Dabigatran Etexilate Mesylate

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
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    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Edoxaban Tosylate

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
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    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Macitentan

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    USDMF

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    CEP/COS

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    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

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    • FDA
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    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Morantel Citrate

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

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    • FDA
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    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Morantel Tartrate

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
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    Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

    Oxantel Pamoate

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    USDMF

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    CEP/COS

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    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

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

    Pyrantel Tartrate

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    USDMF

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    CEP/COS

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    Japanese DMF

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    Status
     
    Filing Details
    Issue/Submission Date
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

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

    Riociguat

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    USDMF

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    CEP/COS

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    Japanese DMF

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    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

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

    Selexipag

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    USDMF

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    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Megafine Pharma CB

    RDD 2024

    Not Confirmed

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