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    Company profile for Antibioticos do Brasil Ltda

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    EVENTS

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    INSPECTIONS & REGISTRATIONS

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    About

    Antibióticos do Brasil Ltda. (ABL) was created in January 2003 from a division of Eli Lilly do Brasil, an American multinational, remaining under ABL brand the entire hospital medication line of Eli Lilly. In April 2003, ABL was incorporated to ACS Dobfar, an Italian group with over 40 years of experience and one of the global leaders in the manufacturing and commercialization of antibiotics (API and finished products). T...
    Antibióticos do Brasil Ltda. (ABL) was created in January 2003 from a division of Eli Lilly do Brasil, an American multinational, remaining under ABL brand the entire hospital medication line of Eli Lilly. In April 2003, ABL was incorporated to ACS Dobfar, an Italian group with over 40 years of experience and one of the global leaders in the manufacturing and commercialization of antibiotics (API and finished products). Therefore ABL was born in Brazil, owning a modern antibiotics factory with the technological support of a sector’s global leader.

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    CONTACT DETAILS

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    Antibioticos do Brasil LtdaBrazil Flag
    Country
    Country
    Brazil
    Address
    Address
    Mall of Maracatins, 508 - 7th floor, Indianapolis - Sao Paulo - SP CEP: 40089...
    Telephone
    Telephone
    +55 800 701 5455
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    http://www.ablbrasil.com.br/
    Linkedin
    Linkedin
    youtube
    YouTube
    Twitter
    Twitter

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    Events

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    PEGS Boston Summit

    PEGS Boston Summit

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    NEWS #PharmaBuzz

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    FDA & EMA both hammer Brazilian sterile antibiotics
    FDA & EMA both hammer Brazilian sterile antibiotics

    31 Jan 2017

    // Eric Palmer FIERCE PHARMA

    http://www.fiercepharma.com/manufacturing/both-fda-ema-hammer-brazilian-sterile-antibiotics-maker-over-contamination-concerns

    Eric Palmer FIERCE PHARMA
    31 Jan 2017
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    Italy bans antibiotic APIs made by Antibioticos do Brasil
    Italy bans antibiotic APIs made by Antibioticos do Brasil

    31 Jan 2017

    // Gareth MacDonald IN PHARMATECHNOLOGIST

    http://www.in-pharmatechnologist.com/Ingredients/Italy-bans-antibiotic-APIs-made-by-Antibioticos-do-Brasil

    Gareth MacDonald IN PHARMATECHNOLOGIST
    31 Jan 2017
    Share Share
    Antibioticos do Brasil Fails EDQM Inspection
    Antibioticos do Brasil Fails EDQM Inspection

    30 Jan 2017

    // EDQM

    https://www.pharmacompass.com/pdf/news/antibioticos-do-brasil-fails-edqm-inspection-1485857458.pdf

    EDQM
    30 Jan 2017
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    Antibioticos do Brasil On Health Canada Inspection List
    Antibioticos do Brasil On Health Canada Inspection List

    25 Jan 2017

    // HEALTH CANADA

    https://www.pharmacompass.com/pdf/news/antibioticos-do-brasil-on-health-canada-inspection-list-1485586813.pdf

    HEALTH CANADA
    25 Jan 2017
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    Antibioticos Do Brasil Ltda Receives FDA Warning Letter
    Antibioticos Do Brasil Ltda Receives FDA Warning Letter

    08 Dec 2016

    // FDA

    https://www.pharmacompass.com/pdf/news/antibioticos-do-brasil-ltda-receives-fda-warning-letter-1482917283.pdf

    FDA
    08 Dec 2016
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    ALL APIs

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

    01

    Cefalotin sodium Sterile

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Cefalotin sodium Sterile

    Brazil

    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 CEP/COS JDMF arrow-down
    ✖

    Registration Number : 219MF10341

    Registrant's Address : Rodovia Professor Zeferino Vaz,SP-332 Km 135 Cosmo(\')polis-SP-Brazil ZpC 13151-350

    Initial Date of Registration : 2007-11-21

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 10402-021

    Start Marketing Date : 2011-06-28

    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
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    02

    Cefepime

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Cefepime

    Brazil

    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 : 2013-06-24

    Pay. Date : 2013-06-14

    DMF Number : 19806

    Submission : 2006-09-26

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    03

    Ceftazidime

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Ceftazidime

    Brazil

    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 CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2010-026 - Rev 03

    Issue Date : 2024-04-15

    Type : Chemical

    Substance Number : 2344

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 10402-013

    Start Marketing Date : 2010-01-20

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

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    Market
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    04

    L-Arginine Hydrochloride API

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    L-Arginine Hydrochloride API

    Brazil

    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 : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19655

    Submission : 2006-08-03

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    05

    Cefoxitin Sodium

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Cefoxitin Sodium

    Brazil

    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 Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19789

    Submission : 2006-09-19

    Status : Inactive

    Type : II

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

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    Market
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    06

    Ceftriaxone

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Ceftriaxone

    Brazil

    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 Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19337

    Submission : 2006-04-04

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Market
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    07

    L-Arginine Hydrochloride API

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    L-Arginine Hydrochloride API

    Brazil

    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 Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21572

    Submission : 2008-02-13

    Status : Inactive

    Type : II

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

    Product
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    Market
    Place

    08

    Cefepime Hydrochloride

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Cefepime Hydrochloride

    Brazil

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

    Registrant Name : Youngjin Pharmaceutical Co., Ltd.

    Registration Date : 2020-07-02

    Registration Number : 20180208-84-D-143-10(2)

    Manufacturer Name : Antibiotics do Brasil Ltda.@ACS Dobfar SpA

    Manufacturer Address : Rodovia Professor Zeferio Vaz, Km 135, SP-332-Itapavussu-13.150-000 Comopolis, SP, Brazil@Viale Addetta 2a/12 20067 Tribiano, MI/ Italy

     VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Cefepime Hydrochloride

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Cefepime Hydrochloride

    Brazil

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

    Registrant Name : BC World Pharmaceutical Co., Ltd.

    Registration Date : 2018-05-29

    Registration Number : 20180208-84-D-143-10(1)

    Manufacturer Name : Antibiotics do Brasil Ltda.@[Antibiotics Manufacturing Company] ACS Dobfar SpA

    Manufacturer Address : Rodovia Professor Zeferio Vaz, Km 135, SP-332-Itapavussu-13.150-000 Comopolis, SP, Brazil@[Viale Addetta 2a/12 20067 Tribiano, MI/ Italy

     VMF Others AUDIT
    blank

    Product
    Web Link

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    Market
    Place

    10

    Cefepime Hydrochloride

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Cefepime Hydrochloride

    Brazil

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

    Registrant Name : Sungjin Exim Co., Ltd.

    Registration Date : 2018-02-08

    Registration Number : 20180208-84-D-143-10

    Manufacturer Name : Antibiotics do Brasil Ltda.@[Antibiotics Manufacturing Company] ACS Dobfar SpA

    Manufacturer Address : Rodovia Professor Zeferino Vaz, Km 135, SP-332, Itapavussu - Cosmópolis - São Paulo - 13151-350 - Brazil@[Manufactory] Viale Addetta 2a/12 20067 Tribiano, MI/ Italy

     VMF Others AUDIT
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    ABOUT THIS PAGE

    Contact Antibioticos do Brasil Ltda and get a quotation

    Antibioticos do Brasil Ltda is a supplier offers 8 products (APIs, Excipients or Intermediates).

    Find Cefalotin sodium Sterile bulk with JDMF offered by Antibioticos do Brasil Ltda

    Find Cefepime bulk with DMF offered by Antibioticos do Brasil Ltda

    Find Ceftazidime bulk with CEP offered by Antibioticos do Brasil Ltda

    Find L-Arginine Hydrochloride API bulk with DMF offered by Antibioticos do Brasil Ltda

    Find Cefoxitin Sodium bulk offered by Antibioticos do Brasil Ltda

    Find Ceftriaxone bulk offered by Antibioticos do Brasil Ltda

    Find L-Arginine Hydrochloride API bulk offered by Antibioticos do Brasil Ltda

    Find Cefepime Hydrochloride bulk offered by Antibioticos do Brasil Ltda

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