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    Company profile for Amino Chemicals

    AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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    PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.

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    Expand your portfolio with Egis- value-added generics, API capabilities, and reliable contract services to drive your growth.

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    About

    Amino Chemicals Ltd. manufactures high quality bulk active ingredients to support its customers for the earliest possible launch of generic pharmaceutical products into regulated markets. Thanks to its US FDA-inspected multi-purpose plant in Malta, the company enjoys from the favourable local patent situation and Bolar provision which allow to fully exploit the potential of new generic APIs, using its own non-infringing proces...
    Amino Chemicals Ltd. manufactures high quality bulk active ingredients to support its customers for the earliest possible launch of generic pharmaceutical products into regulated markets. Thanks to its US FDA-inspected multi-purpose plant in Malta, the company enjoys from the favourable local patent situation and Bolar provision which allow to fully exploit the potential of new generic APIs, using its own non-infringing processes while guaranteeing the full respect of third parties' rights in the destination countries. Production scale ranges from few KGs to tons per month.

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    CONTACT DETAILS

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    Amino ChemicalsMalta Flag
    Country
    Country
    Malta
    Address
    Address
    Amino Chemicals Ltd. A50, Industrial EstateMRS3000 Marsa– Malta
    Telephone
    Telephone
    356 224 895 23
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://aminochemicals.com/
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    Linkedin
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    Twitter

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    NEWS #PharmaBuzz

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    Dipharma Francis divests Malta-based subsidiary, Amino Chemicals ABA Chemicals
    Dipharma Francis divests Malta-based subsidiary, Amino Chemicals ABA Chemicals

    05 Jul 2017

    // PHARMABIZ

    http://www.pharmabiz.com/NewsDetails.aspx?aid=102984&sid=2

    PHARMABIZ
    05 Jul 2017
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    ALL APIs

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

    01

    Terbinafine Hydrochloride

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

    PCC
    Not Confirmed
    arrow

    Terbinafine Hydrochloride

    Malta

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

    arrow
    PCC
    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 Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16283

    Submission : 2002-11-28

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-346 - Rev 01

    Issue Date : 2017-09-04

    Type : Chemical

    Substance Number : 1734

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 221MF10044

    Registrant's Address : A61, Industrial Estate, Marsa LQA 06 Malta

    Initial Date of Registration : 2009-02-25

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Kolon Pharmaceutical Co., Ltd.

    Registration Date : 2022-12-15

    Registration Number : 20221215-49-A-375-22

    Manufacturer Name : Amino Chemicals Ltd

    Manufacturer Address : MRA 050X Industrial Estate, Marsa MRS 3000, Malta

     VMF Others AUDIT
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    Product
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    Market
    Place

    02

    Benazepril Hydrochloride

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

    PCC
    Not Confirmed
    arrow

    Benazepril Hydrochloride

    Malta

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19148

    Submission : 2006-02-02

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 217MF11297

    Registrant's Address : MRA050X, INDUSTRIAL ESTATE MARSA MRS 3000 Malta

    Initial Date of Registration : 2005-12-22

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    Product
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    Market
    Place

    03

    Pramipexole Dihydrochloride

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

    PCC
    Not Confirmed
    arrow

    Pramipexole Dihydrochloride

    Malta

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-04-12

    Pay. Date : 2019-02-19

    DMF Number : 18297

    Submission : 2005-04-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2011-127 - Rev 02

    Issue Date : 2018-09-25

    Type : Chemical

    Substance Number : 2416

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Samil Pharmaceutical Co., Ltd.

    Registration Date : 2019-04-11

    Registration Number : 20181008-209-J-125(1)

    Manufacturer Name : Amino Chemicals Ltd.

    Manufacturer Address : MRA 050X Marsa Industrial Estate, MRS3000, Malta

     VMF Others AUDIT
    blank

    Product
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    Market
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    04

    Telmisartan

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

    Bioprocess International Europe
    Not Confirmed
    arrow

    Telmisartan

    Malta

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

    arrow
    Bioprocess International Europe
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20882

    Submission : 2007-09-26

    Status : Active

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R0-CEP 2010-093 - Rev 00

    Issue Date : 2012-10-11

    Type : Chemical

    Substance Number : 2154

    Status : Withdrawn by Holder

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    05

    Ziprasidone Hydrochloride

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

    PCC
    Not Confirmed
    arrow

    Ziprasidone Hydrochloride

    Malta

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

    arrow
    PCC
    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 Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20105

    Submission : 2006-12-27

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2010-358 - Rev 01

    Issue Date : 2023-10-06

    Type : Chemical

    Substance Number : 2421

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 66005-0027

    Start Marketing Date : 2009-04-29

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    06

    Bosentan Hydrate

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

    PCC
    Not Confirmed
    arrow

    Bosentan Hydrate

    Malta

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

    arrow
    PCC
    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 : 23455

    Submission : 2010-01-14

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    blank

    Product
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    Market
    Place

    07

    Paliperidone

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

    PCC
    Not Confirmed
    arrow

    Paliperidone

    Malta

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

    arrow
    PCC
    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 : 2025-09-24

    Pay. Date : 2025-09-19

    DMF Number : 24263

    Submission : 2010-10-06

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 66005-0050

    Start Marketing Date : 2022-06-07

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

    Product
    Web Link

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    Market
    Place

    08

    Pramipexole Dihydrochloride

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

    PCC
    Not Confirmed
    arrow

    Pramipexole Dihydrochloride

    Malta

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

    arrow
    PCC
    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 : 2019-05-30

    Pay. Date : 2018-09-14

    DMF Number : 32872

    Submission : 2018-11-07

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Sam-O Pharmaceutical Co., Ltd.

    Registration Date : 2018-10-08

    Registration Number : 20181008-209-J-125

    Manufacturer Name : Amino Chemicals Ltd.

    Manufacturer Address : MRA 050X Marsa Industrial Estate, MRS3000, Malta

     VMF Others AUDIT
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    Product
    Web Link

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    Market
    Place

    09

    Rasagiline Mesylate

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

    PCC
    Not Confirmed
    arrow

    Rasagiline Mesylate

    Malta

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

    arrow
    PCC
    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 : 22667

    Submission : 2009-03-25

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 66005-0029

    Start Marketing Date : 2009-05-14

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

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    10

    Tolterodine Tartrate

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

    PCC
    Not Confirmed
    arrow

    Tolterodine Tartrate

    Malta

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

    arrow
    PCC
    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 : 20093

    Submission : 2006-12-21

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Market
    Place

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    ABOUT THIS PAGE

    Contact Amino Chemicals and get a quotation

    Amino Chemicals is a supplier offers 42 products (APIs, Excipients or Intermediates).

    Find a price of Terbinafine Hydrochloride bulk with DMF, CEP, JDMF offered by Amino Chemicals

    Find a price of Benazepril Hydrochloride bulk with DMF, JDMF offered by Amino Chemicals

    Find a price of Pramipexole Dihydrochloride bulk with DMF, CEP offered by Amino Chemicals

    Find a price of Telmisartan bulk with DMF offered by Amino Chemicals

    Find a price of Ziprasidone Hydrochloride bulk with CEP offered by Amino Chemicals

    Find a price of Bosentan Hydrate bulk with DMF offered by Amino Chemicals

    Find a price of Fexofenadine Hydrochloride bulk with JDMF offered by Amino Chemicals

    Find a price of Miglustat bulk with JDMF offered by Amino Chemicals

    Find a price of Paliperidone bulk with DMF offered by Amino Chemicals

    Find a price of Pantoprazole Sodium bulk offered by Amino Chemicals

    Find a price of Pramipexole Dihydrochloride bulk with DMF offered by Amino Chemicals

    Find a price of Rasagiline Mesylate bulk with DMF offered by Amino Chemicals

    Find a price of Terbinafine Hydrochloride bulk with CEP offered by Amino Chemicals

    Find a price of Tolterodine Tartrate bulk with DMF offered by Amino Chemicals

    Find a price of Ziprasidone Hydrochloride bulk with DMF offered by Amino Chemicals

    Find a price of Adapalene bulk offered by Amino Chemicals

    Find a price of Fosinopril bulk offered by Amino Chemicals

    Find a price of Granisetron Hydrochloride bulk offered by Amino Chemicals

    Find a price of Imiquimod bulk offered by Amino Chemicals

    Find a price of Modafinil bulk offered by Amino Chemicals

    Find a price of Olmesartan Medoxomil bulk offered by Amino Chemicals

    Find a price of Rabeprazole Sodium bulk offered by Amino Chemicals

    Find a price of Venlafaxine Hydrochloride bulk offered by Amino Chemicals

    Find a price of Zaleplon bulk offered by Amino Chemicals

    Find a price of Apixaban bulk offered by Amino Chemicals

    Find a price of Armodafinil bulk offered by Amino Chemicals

    Find a price of Benazepril bulk offered by Amino Chemicals

    Find a price of Bilastine bulk offered by Amino Chemicals

    Find a price of Brivaracetam bulk offered by Amino Chemicals

    Find a price of Cinacalcet Hydrochloride bulk offered by Amino Chemicals

    Find a price of Cyproheptadine Hydrochloride bulk offered by Amino Chemicals

    Find a price of Dexlansoprazole bulk offered by Amino Chemicals

    Find a price of Dextropropoxyphene bulk offered by Amino Chemicals

    Find a price of Eltrombopag bulk offered by Amino Chemicals

    Find a price of Fesoterodine bulk offered by Amino Chemicals

    Find a price of Lifitegrast bulk offered by Amino Chemicals

    Find a price of Linagliptin bulk offered by Amino Chemicals

    Find a price of Mirabegron bulk offered by Amino Chemicals

    Find a price of Nitisinone bulk offered by Amino Chemicals

    Find a price of Rasagiline Tartrate bulk offered by Amino Chemicals

    Find a price of Rufinamide bulk offered by Amino Chemicals

    Find a price of Sacubitril Sodium bulk offered by Amino Chemicals

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