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    Looking for excipients offered by Apothecon Pharmaceuticals? Find information on Apothecon Pharmaceuticals's regulatory filings (DMFs), cGMP inspections, pricing availability, etc. on PharmaCompass.

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    EVENTS

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    About

    Apothecon Pharmaceuticals is a developer & manufacturer of niche generic APIs & FDFs. It is the Indian counterpart of Navinta LLC, USA. Certified by all the top regulatory authorities namely-US FDA, UK MHRA, WHO & State GMP, TGA, ANVISA, MFDS & the MOH of Turkey, Russia, Libya & Yemen. With the implementation of backward integration for its product manufacturing, they have strong controls over quality & supply chain which faci...
    Apothecon Pharmaceuticals is a developer & manufacturer of niche generic APIs & FDFs. It is the Indian counterpart of Navinta LLC, USA. Certified by all the top regulatory authorities namely-US FDA, UK MHRA, WHO & State GMP, TGA, ANVISA, MFDS & the MOH of Turkey, Russia, Libya & Yemen. With the implementation of backward integration for its product manufacturing, they have strong controls over quality & supply chain which facilitates timely deliverables. More than 15+ DMFs & ANDA filings are often amongst the first few generics in the world with their pick of complex & lucrative molecules whose development they have expertise in.

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    CONTACT DETAILS

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    Apothecon Pharmaceuticalsindia-flag Flag
    Country
    Country
    India
    Address
    Address
    Padra – Jambusar Highway, P.O. – Dabhasa, Pin – 391 440, Ta. Padra, Dist...
    Telephone
    Telephone
    +91 2662244211
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.apotheconpharma.com/
    Linkedin
    Linkedin
    https://www.linkedin.com/company/apothecon-pharmaceuticals-pvt-ltd
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    YouTube
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    Twitter

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    SCOPE Summit

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    Meeting

    ALL APIs

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    01

    Bendamustine Hydrochloride

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

    SCOPE Summit
    Not Confirmed
    arrow

    Bendamustine Hydrochloride

    India

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

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    SCOPE Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-12-18

    Pay. Date : 2013-09-18

    DMF Number : 27272

    Submission : 2013-09-19

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0369n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 76339-156

    Start Marketing Date : 2019-09-07

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (9.999kg/9.999kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    02

    Carmustine

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

    SCOPE Summit
    Not Confirmed
    arrow

    Carmustine

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-01-13

    Pay. Date : 2016-09-02

    DMF Number : 30492

    Submission : 2016-09-06

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0369n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 76339-121

    Start Marketing Date : 2019-09-06

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (4.999kg/4.999kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : HO Pharm Co., Ltd.

    Registration Date : 2021-04-26

    Registration Number : 20210426-210-J-954

    Manufacturer Name : Apothecon Pharmaceuticals Pvt. Limited

    Manufacturer Address : PLOT NO 1134, 1135, 1136, 1137, 1143B, 1144 A&B, 1138 A&B, Padra Jambusar Highway, Tal-Padra, Village-Dabhasa, City. Dabhasa-391 440, Dist. Vadodara, Gujarat State, India

     VMF Others AUDIT
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    03

    Cyclophosphamide

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

    SCOPE Summit
    Not Confirmed
    arrow

    Cyclophosphamide

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-11-17

    Pay. Date : 2021-09-27

    DMF Number : 35975

    Submission : 2021-09-28

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0369n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 76339-191

    Start Marketing Date : 2022-09-23

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (9.999kg/9.999kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    04

    Iron Sucrose

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

    SCOPE Summit
    Not Confirmed
    arrow

    Iron Sucrose

    India

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18261

    Submission : 2005-04-11

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-08-04

    Valid Till : 2022-08-09

    Written Confirmation Number : WC-0369A4

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 76339-166

    Start Marketing Date : 2023-11-23

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (24.999kg/24.999kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    05

    Melphalan Hydrochloride

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

    SCOPE Summit
    Not Confirmed
    arrow

    Melphalan Hydrochloride

    India

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

    arrow
    SCOPE 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 : 2015-12-18

    Pay. Date : 2015-09-25

    DMF Number : 29766

    Submission : 2015-09-29

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0369n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 76339-501

    Start Marketing Date : 2024-01-31

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (4.999kg/4.999kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    06

    Nicardipine Hydrochloride

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

    SCOPE Summit
    Not Confirmed
    arrow

    Nicardipine Hydrochloride

    India

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

    arrow
    SCOPE 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 : 2020-10-05

    Pay. Date : 2020-09-29

    DMF Number : 19773

    Submission : 2006-09-15

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-01

    Valid Till : 2022-09-08

    Written Confirmation Number : WC-0369A7

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 76339-117

    Start Marketing Date : 2020-12-05

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (4.999kg/4.999kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Agerson Bio Co., Ltd.

    Registration Date : 2023-04-04

    Registration Number : 20230404-210-J-1467

    Manufacturer Name : Apothecon Pharmaceuticals Pvt. Ltd.

    Manufacturer Address : PLOT NO 1134, 1135, 1136, 1137, 1143B, 1144 A&B, 1138 A&B, Padra Jambusar Highway, Tal-Padra, Village-Dabhasa, City. Dabhasa-391 440, Dist. Vadodara, Gujarat State, India

     VMF Others AUDIT
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    07

    Ropivacaine Hydrochloride

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

    SCOPE Summit
    Not Confirmed
    arrow

    Ropivacaine Hydrochloride

    India

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

    arrow
    SCOPE 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 : 19084

    Submission : 2005-12-30

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0369n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 76339-124

    Start Marketing Date : 2021-11-24

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (29.999kg/29.999kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Medipoem Co., Ltd.

    Registration Date : 2025-07-24

    Registration Number : 20230406-210-J-1291(A)

    Manufacturer Name : Apothecon Pharmaceuticals Pvt. Ltd.

    Manufacturer Address : PLOT NO 1134, 1135, 1136, 1137, 1143B, 1144 A&B, 1138 A&B, Padra Jambusar Highway, PO -Dabhasa -391 440, Tal-Padra, Dist. -Vadodara, Gujarat State, India

     VMF Others AUDIT
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    08

    Ropivacaine Hydrochloride

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

    SCOPE Summit
    Not Confirmed
    arrow

    Ropivacaine Hydrochloride

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-01-04

    Pay. Date : 2016-09-22

    DMF Number : 30152

    Submission : 2016-09-23

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0369n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 76339-126

    Start Marketing Date : 2019-12-28

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (19.999kg/19.999kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Ace Biopharm Co., Ltd.

    Registration Date : 2023-04-06

    Registration Number : 20230406-210-J-1291

    Manufacturer Name : Apothecon Pharmaceuticals Pvt. Ltd.

    Manufacturer Address : Plot No. 1134, 1135, 1136, 1137, 1143B, 1144A & 1144B, 1138A & 1138B, Pandra-Jambusar Highway, Tal. Padra, P.O. Dabhasa, Pin 391 440, District Vandodara, Gujarat State, India.

     VMF Others AUDIT
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    09

    Sevelamer Carbonate

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

    SCOPE Summit
    Not Confirmed
    arrow

    Sevelamer Carbonate

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-04-28

    Pay. Date : 2014-01-02

    DMF Number : 27405

    Submission : 2014-01-02

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0369n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 76339-511

    Start Marketing Date : 2024-12-10

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (9.999kg/9.999kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    10

    Trientine Hydrochloride

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

    SCOPE Summit
    Not Confirmed
    arrow

    Trientine Hydrochloride

    India

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

    arrow
    SCOPE Summit
    Not Confirmed
    • fda
    • EDQM
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-03-17

    Pay. Date : 2016-09-14

    DMF Number : 30905

    Submission : 2016-09-15

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0369n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 76339-133

    Start Marketing Date : 2019-09-06

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (9.999kg/9.999kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Contact Apothecon Pharmaceuticals and get a quotation

    Apothecon Pharmaceuticals is a supplier offers 39 products (APIs, Excipients or Intermediates).

    Find a price of Bendamustine Hydrochloride bulk with DMF offered by Apothecon Pharmaceuticals

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    Find a price of Ropivacaine Hydrochloride bulk with DMF offered by Apothecon Pharmaceuticals

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    Find a price of Hydralazine Hydrochloride bulk with DMF offered by Apothecon Pharmaceuticals

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    Find a price of Penicillamine bulk with DMF offered by Apothecon Pharmaceuticals

    Find a price of Phenoxybenzamine HCl bulk with DMF offered by Apothecon Pharmaceuticals

    Find a price of Remifentanil bulk with DMF offered by Apothecon Pharmaceuticals

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    Find a price of Sodium ferric gluconate bulk with DMF offered by Apothecon Pharmaceuticals

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    Find a price of Taurolidine bulk with DMF offered by Apothecon Pharmaceuticals

    Find a price of DS108 DRUG SUBSTANCE bulk with DMF offered by Apothecon Pharmaceuticals

    Find a price of Sodium Phenylbutyrate bulk offered by Apothecon Pharmaceuticals

    Find a price of Argatroban bulk offered by Apothecon Pharmaceuticals

    Find a price of Benzoic Acid bulk offered by Apothecon Pharmaceuticals

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    Find a price of Indomethacin Sodium bulk offered by Apothecon Pharmaceuticals

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    Find a price of Salcaprozate Sodium bulk offered by Apothecon Pharmaceuticals

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