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    Company profile for Megafine Pharma (P) Limited

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    China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress

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    EVENTS

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    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 &...
    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.

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    Megafine Pharma (P) Limitedindia-flag Flag
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    India
    Address
    Address
    Sethna 4th floor, 55 Maharshi Karve Road, Marine Lines, Mumbai – 400 002 Mah...
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    Email
    enquiries@pharmacompass.com
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    Website
    http://megafine.in/
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    NEWS #PharmaBuzz

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    Motilal Oswal Invests INR 460 Crore For Majority Stake In Megafine
    Motilal Oswal Invests INR 460 Crore For Majority Stake In Megafine

    02 Mar 2025

    // EXPRESSPHARMA

    https://www.expresspharma.in/motilal-oswal-alternates-invests-up-to-inr-460-crores-for-majority-stake-in-megafine/

    EXPRESSPHARMA
    02 Mar 2025
    Share Share
    MO Alts Acquires Majority Stake in Megafine for Rs 460 Cr
    MO Alts Acquires Majority Stake in Megafine for Rs 460 Cr

    25 Feb 2025

    // BUSINESS STD

    https://www.business-standard.com/industry/news/mo-alts-acquires-majority-stake-in-megafine-pharma-for-rs-460-crore-125022501188_1.html

    BUSINESS STD
    25 Feb 2025
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    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
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    ALL APIs

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    01

    Pyrantel Pamoate

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Pyrantel Pamoate

    India

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down Click Us! 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 : 2025-10-01

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0087

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22665-0002

    Start Marketing Date : 2010-07-19

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
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    02

    Donepezil

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Donepezil

    India

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF 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-WCInactive-api
    ✖

    Date of Issue : 2023-05-15

    Valid Till : 2026-01-19

    Written Confirmation Number : WC-0462

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
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    03

    Memantine Hydrochloride

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Memantine Hydrochloride

    India

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-08-22

    Pay. Date : 2013-04-15

    DMF Number : 25402

    Submission : 2011-10-14

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2025-233 - Rev 00

    Issue Date : 2026-03-25

    Type : Chemical

    Substance Number : 2773

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-10-01

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0087

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22665-0015

    Start Marketing Date : 2011-03-24

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : IMCD Korea Co., Ltd.

    Registration Date : 2020-09-04

    Registration Number : 20200904-209-J-373

    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 – 422 202, Maharashtra, India.

     VMF Others AUDIT arrow-down
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    04

    Mirabegron

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Mirabegron

    India

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-02-05

    Pay. Date : 2015-09-30

    DMF Number : 29773

    Submission : 2015-09-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2024-087 - Rev 02

    Issue Date : 2025-11-14

    Type : Chemical

    Substance Number : 3132

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-10-01

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0087

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : SG Biochem Co., Ltd.

    Registration Date : 2026-04-09

    Registration Number : Su386-5-ND

    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 State, India

     VMF Others AUDIT arrow-down
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    05

    Mirtazapine

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Mirtazapine

    India

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    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 : CEP 2024-116 - Rev 01

    Issue Date : 2026-04-17

    Type : Chemical

    Substance Number : 2338

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-10-01

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0087

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22665-0001

    Start Marketing Date : 2026-01-02

    End Marketing Date : 2027-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
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    Place

    06

    Quetiapine Hemifumarate

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Quetiapine Hemifumarate

    India

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    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 02

    Issue Date : 2025-05-30

    Type : Chemical

    Substance Number : 2541

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-10-01

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0087

    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 Others AUDIT arrow-down
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    07

    Rivaroxaban

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Rivaroxaban

    India

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    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 : 2025-10-01

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0087

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
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    08

    Solifenacin Succinate

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Solifenacin Succinate

    India

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    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 : CEP 2024-463 - Rev 00

    Issue Date : 2025-01-02

    Type : Chemical

    Substance Number : 2779

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-10-01

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0087

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
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    09

    Teriflunomide

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Teriflunomide

    India

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
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    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 : 2025-10-01

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0087

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
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    10

    Venlafaxine Hydrochloride

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Venlafaxine Hydrochloride

    India

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
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    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 : 2025-10-01

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0087

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
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    ABOUT THIS PAGE

    Contact Megafine Pharma (P) Limited and get a quotation

    Megafine Pharma (P) Limited is a supplier offers 37 products (APIs, Excipients or Intermediates).

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

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