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    Company profile for Alkaloida Chemical Company Zrt

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    EVENTS

    ACTIVE PHARMA INGREDIENTS

    FINISHED DOSAGE FORMULATIONS

    INSPECTIONS & REGISTRATIONS

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    About

    ALKALOIDA Chemical Company Zrt. (hereinafter referred to as “Company”) is the member of the SUN Pharmaceutical Industries Ltd. international corporation based in India.

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    CONTACT DETAILS

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    Alkaloida Chemical Company ZrtHungary Flag
    Country
    Country
    Hungary
    Address
    Address
    4440 Tiszavasvári, Kabay János u. 29
    Telephone
    Telephone
    +36 42 521 000
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://sunpharma.com/
    Linkedin
    Linkedin
    youtube
    YouTube
    Twitter
    Twitter

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    Events

    Webinars & Exhibitions

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    ELCC

    ELCC

    Not Confirmed

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    ELCC

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    Meeting

    ALL APIs

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

    01

    Phenobarbital

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

    ELCC
    Not Confirmed
    arrow

    Phenobarbital

    Hungary

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

    arrow
    ELCC
    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 : 4642

    Submission : 1982-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2009-132 - Rev 03

    Issue Date : 2021-12-08

    Type : Chemical

    Substance Number : 201

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 50095-001

    Start Marketing Date : 1982-11-05

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Phenobarbital Sodium

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

    ELCC
    Not Confirmed
    arrow

    Phenobarbital Sodium

    Hungary

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2020-03-31

    Pay. Date : 2020-03-06

    DMF Number : 34598

    Submission : 2020-03-10

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2021-501 - Rev 00

    Issue Date : 2023-04-04

    Type : Chemical

    Substance Number : 630

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 50095-003

    Start Marketing Date : 2023-12-05

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Codeine

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

    ELCC
    Not Confirmed
    arrow

    Codeine

    Hungary

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

    arrow
    ELCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2022-142 - Rev 00

    Issue Date : 2022-12-01

    Type : Chemical

    Substance Number : 76

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

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    Market
    Place

    04

    Codeine Phosphate

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

    ELCC
    Not Confirmed
    arrow

    Codeine Phosphate

    Hungary

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

    arrow
    ELCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2006-199 - Rev 01

    Issue Date : 2021-02-16

    Type : Chemical

    Substance Number : 74

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Baeksu Pharmaceutical Co., Ltd.

    Registration Date : 2022-09-08

    Registration Number : 20210406-209-J-923(A)

    Manufacturer Name : Alkaloida Chemical Company Zrt. @Sun Pharmaceutical Industries Australia Pty Ltd

    Manufacturer Address : Kabay Janos u.29., Tiszavasvari, 4440, Hungary@Princes Highway, Port Fairy VIC 3284, Australia

     VMF Others AUDIT arrow-down
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    Product
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    Market
    Place

    05

    Codeine Phosphate

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

    ELCC
    Not Confirmed
    arrow

    Codeine Phosphate

    Hungary

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

    arrow
    ELCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2024-443 - Rev 00

    Issue Date : 2025-02-07

    Type : Chemical

    Substance Number : 74

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Samung Industrial Co., Ltd.

    Registration Date : 2021-04-06

    Registration Number : 20210406-209-J-923

    Manufacturer Name : ALKALOIDA Chemical Company Zrt@Sun pharmaceutical Industries Australia Pty Ltd

    Manufacturer Address : Kabay Janos u.29., Tiszavasvari, 4440, Hungary@Princes Highway, Port Fairy ViC 3284, Australia

     VMF Others AUDIT arrow-down
    blank

    Product
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    Market
    Place

    06

    Dihydrocodeine Hydrogen Tartrate

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

    ELCC
    Not Confirmed
    arrow

    Dihydrocodeine Hydrogen Tartrate

    Hungary

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

    arrow
    ELCC
    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 CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2009-225 - Rev 02

    Issue Date : 2020-08-21

    Type : Chemical

    Substance Number : 1776

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Baeksu Pharmaceutical Co., Ltd.

    Registration Date : 2021-09-07

    Registration Number : 20210511-209-J-706(A)

    Manufacturer Name : Alkaloida Chemical Company Zrt.

    Manufacturer Address : Kabay Janos u.29., Tiszavasvari, 4440, Hungary

     VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Hydroxychloroquine Sulphate

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

    ELCC
    Not Confirmed
    arrow

    Hydroxychloroquine Sulphate

    Hungary

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

    arrow
    ELCC
    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 : 2018-05-11

    Pay. Date : 2018-04-04

    DMF Number : 23582

    Submission : 2010-03-25

    Status : Active

    Type : II

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Noscapine

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

    ELCC
    Not Confirmed
    arrow

    Noscapine

    Hungary

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

    arrow
    ELCC
    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 CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2018-067 - Rev 01

    Issue Date : 2024-06-17

    Type : Chemical

    Substance Number : 516

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Noscapine Hydrochloride

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

    ELCC
    Not Confirmed
    arrow

    Noscapine Hydrochloride

    Hungary

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

    arrow
    ELCC
    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 CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-222 - Rev 01

    Issue Date : 2024-06-17

    Type : Chemical

    Substance Number : 515

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Pholcodine

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

    ELCC
    Not Confirmed
    arrow

    Pholcodine

    Hungary

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

    arrow
    ELCC
    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 CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2016-268 - Rev 01

    Issue Date : 2024-01-25

    Type : Chemical

    Substance Number : 522

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

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

    USDMF

    read-more
    read-more

    01

    Buspirone Base

    Hungary
    ELCC
    Not Confirmed
    arrow

    02

    Buspirone Hydrochloride

    Hungary
    ELCC
    Not Confirmed
    arrow

    03

    Hydroxychloroquine Sulfate

    Hungary
    ELCC
    Not Confirmed
    arrow

    04

    Hydroxychloroquine Sulfate Usp

    Hungary
    ELCC
    Not Confirmed
    arrow

    05

    Mexiletine Hydrochloride Usp Bulk

    Hungary
    ELCC
    Not Confirmed
    arrow

    06

    Phenobarbital Sodium, Usp

    Hungary
    ELCC
    Not Confirmed
    arrow

    07

    Phenobarbital Usp

    Hungary
    ELCC
    Not Confirmed
    arrow

    08

    Topiramate

    Hungary
    ELCC
    Not Confirmed
    arrow
    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    CEP/COS

    read-more
    read-more

    01

    Codeine monohydrate

    CEP/COS

    ELCC
    Not Confirmed
    arrow

    02

    Codeine phosphate hemihydrate

    CEP/COS

    ELCC
    Not Confirmed
    arrow

    03

    Codeine phosphate hemihydrate, Process 2

    CEP/COS

    ELCC
    Not Confirmed
    arrow

    04

    Dihydrocodeine hydrogen tartrate

    CEP/COS

    ELCC
    Not Confirmed
    arrow

    05

    Noscapine

    CEP/COS

    ELCC
    Not Confirmed
    arrow

    06

    Noscapine Hydrochloride Hydrate

    CEP/COS

    ELCC
    Not Confirmed
    arrow

    07

    Oxycodone hydrochloride

    CEP/COS

    ELCC
    Not Confirmed
    arrow

    08

    Phenobarbital

    CEP/COS

    ELCC
    Not Confirmed
    arrow

    09

    Phenobarbital Sodium

    CEP/COS

    ELCC
    Not Confirmed
    arrow

    10

    Pholcodine monohydrate

    CEP/COS

    ELCC
    Not Confirmed
    arrow
    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    KDMF

    read-more
    read-more

    01

    codeine phosphate monohydrate

    Hungary
    ELCC
    Not Confirmed
    arrow

    codeine phosphate monohydrate

    Hungary
    arrow
    ELCC
    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.

    Alkaloida Chemical Company Zrt

    Registrant Name : Baeksu Pharmaceutical Co., Ltd.

    Registration Date : 2022-09-08

    Registration Number : 20210406-209-J-923(A)

    Manufacturer Name : Alkaloida Chemical Company Zrt...

    Manufacturer Address : Kabay Janos u.29., Tiszavasvari, 4440, Hungary@Princes Highway, Port Fairy VIC 3284, ...

    blank

    Product
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    Market
    Place

    02

    codeine phosphate monohydrate

    Hungary
    ELCC
    Not Confirmed
    arrow

    codeine phosphate monohydrate

    Hungary
    arrow
    ELCC
    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.

    Alkaloida Chemical Company Zrt

    Registrant Name : Samung Industrial Co., Ltd.

    Registration Date : 2021-04-06

    Registration Number : 20210406-209-J-923

    Manufacturer Name : ALKALOIDA Chemical Company Zrt...

    Manufacturer Address : Kabay Janos u.29., Tiszavasvari, 4440, Hungary@Princes Highway, Port Fairy ViC 3284, ...

    blank

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    03

    dihydrocodeine tartrate

    Hungary
    ELCC
    Not Confirmed
    arrow

    dihydrocodeine tartrate

    Hungary
    arrow
    ELCC
    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.

    Alkaloida Chemical Company Zrt

    Registrant Name : Samung Industrial Co., Ltd.

    Registration Date : 2021-05-11

    Registration Number : 20210511-209-J-706

    Manufacturer Name : ALKALOIDA Chemical Company Zrt

    Manufacturer Address : Kabay Janos u.29., Tiszavasvari, 4440, Hungary

    blank

    Product
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    #Pipeline Prospector

    Market
    Place

    04

    dihydrocodeine tartrate

    Hungary
    ELCC
    Not Confirmed
    arrow

    dihydrocodeine tartrate

    Hungary
    arrow
    ELCC
    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.

    Alkaloida Chemical Company Zrt

    Registrant Name : Baeksu Pharmaceutical Co., Ltd.

    Registration Date : 2021-09-07

    Registration Number : 20210511-209-J-706(A)

    Manufacturer Name : Alkaloida Chemical Company Zrt...

    Manufacturer Address : Kabay Janos u.29., Tiszavasvari, 4440, Hungary

    blank

    Product
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    Market
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    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    NDC API

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    read-more

    01

    PHENOBARBITAL

    Hungary
    ELCC
    Not Confirmed
    arrow

    PHENOBARBITAL

    Hungary
    arrow
    ELCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Alkaloida Chemical Company Zrt

    NDC Package Code : 50095-001

    Start Marketing Date : 1982-11-05

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    blank

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    Market
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    02

    PHENOBARBITAL SODIUM

    Hungary
    ELCC
    Not Confirmed
    arrow
    Only 10 entries up to this point, click to access all click full view read-more
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    Inspections and registrations

    Upload your audits for free, ask us

    FDA

    read-more
    read-more

    01

    FDA Audited

    USA
    ELCC
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    ELCC
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2025-03-12

    Alkaloida Chemical Company Zrt

    City : Tiszavasvari

    State :

    Country/Area : Hungary

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2025-03-12

    blank

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    Web Link

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    Data Compilation
    #PharmaFlow

    02

    FDA Audited

    USA
    ELCC
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    ELCC
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2019-09-13

    Alkaloida Chemical Company Zrt

    City : Tiszavasvari

    State :

    Country/Area : Hungary

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2019-09-13

    blank

    Product
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    Stock Recap
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    Data Compilation
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    03

    FDA Audited

    USA
    ELCC
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    ELCC
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-03-10

    Alkaloida Chemical Company Zrt

    City : Tiszavasvari

    State :

    Country/Area : Hungary

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-03-10

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    Product
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    Data Compilation
    #PharmaFlow

    04

    FDA Audited

    USA
    ELCC
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    ELCC
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-09-04

    Alkaloida Chemical Company Zrt

    City : Tiszavasvari

    State :

    Country/Area : Hungary

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-09-04

    blank

    Product
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    05

    FDA Audited

    USA
    ELCC
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    ELCC
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-05-22

    Alkaloida Chemical Company Zrt

    City : Tiszavasvari

    State :

    Country/Area : Hungary

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-05-22

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    06

    FDA Audited

    USA
    ELCC
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    ELCC
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2011-06-27

    Alkaloida Chemical Company Zrt

    City : Tiszavasvari

    State :

    Country/Area : Hungary

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2011-06-27

    blank

    Product
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    ABOUT THIS PAGE

    Contact Alkaloida Chemical Company Zrt and get a quotation

    Alkaloida Chemical Company Zrt is a supplier offers 16 products (APIs, Excipients or Intermediates).

    Find a price of Phenobarbital bulk with DMF, CEP offered by Alkaloida Chemical Company Zrt

    Find a price of Phenobarbital Sodium bulk with DMF, CEP offered by Alkaloida Chemical Company Zrt

    Find a price of Codeine bulk with CEP offered by Alkaloida Chemical Company Zrt

    Find a price of Codeine Phosphate bulk with CEP offered by Alkaloida Chemical Company Zrt

    Find a price of Dihydrocodeine Hydrogen Tartrate bulk with CEP offered by Alkaloida Chemical Company Zrt

    Find a price of Hydroxychloroquine Sulphate bulk with DMF offered by Alkaloida Chemical Company Zrt

    Find a price of Noscapine bulk with CEP offered by Alkaloida Chemical Company Zrt

    Find a price of Noscapine Hydrochloride bulk with CEP offered by Alkaloida Chemical Company Zrt

    Find a price of Pholcodine bulk with CEP offered by Alkaloida Chemical Company Zrt

    Find a price of Buspirone bulk offered by Alkaloida Chemical Company Zrt

    Find a price of Buspirone Hydrochloride bulk offered by Alkaloida Chemical Company Zrt

    Find a price of Hydroxychloroquine Sulphate bulk offered by Alkaloida Chemical Company Zrt

    Find a price of Mexiletine bulk offered by Alkaloida Chemical Company Zrt

    Find a price of Oxycodone Hydrochloride bulk offered by Alkaloida Chemical Company Zrt

    Find a price of Topiramate bulk offered by Alkaloida Chemical Company Zrt

    Find a price of Dihydrocodeine Hydrogen Tartrate bulk offered by Alkaloida Chemical Company Zrt

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