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    Company profile for SINTENOVO, S.A. DE C.V.

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    EVENTS

    ACTIVE PHARMA INGREDIENTS

    INSPECTIONS & REGISTRATIONS

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    Only Regulatory Products (API/FDF), Drugs in Developments and News are Updated on this Virtual Booth

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    About

    Sintenovo, S.A. de C.V., Mexican subsidiary of the Spanish firm EQ Esteve, develops, produces and markets API's for the major world markets. Sintenovo has two plants in Mexico, one in Naucalpan, Estado de Mexico, and another in Jiutepec, Estado de Morelos (start-up in 2007). Sintenovo conducts business by working in accordance with the GMP guidelines as well as the international standards concerning Quality, Safety and the Env...
    Sintenovo, S.A. de C.V., Mexican subsidiary of the Spanish firm EQ Esteve, develops, produces and markets API's for the major world markets. Sintenovo has two plants in Mexico, one in Naucalpan, Estado de Mexico, and another in Jiutepec, Estado de Morelos (start-up in 2007). Sintenovo conducts business by working in accordance with the GMP guidelines as well as the international standards concerning Quality, Safety and the Environment. The Naucalpan plant has been inspected by the FDA since 1995. Both plants have been approved by the Mexican authorities (SecretarIa de Salud) and the European health officials (EMA).

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    CONTACT DETAILS

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    SINTENOVO, S.A. DE C.V.Mexico Flag
    Country
    Country
    Mexico
    Address
    Address
    Calle 13 Este Nº 3, Civac
    Telephone
    Telephone
    52 777 320 6162
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    http://www.sintenovo.com
    Linkedin
    Linkedin
    youtube
    YouTube
    Twitter
    Twitter

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    Events

    Webinars & Exhibitions

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    BioProcess International US West

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    BioProcess International US West

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    Meeting

    ALL APIs

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    01

    Omeprazole Magnesium

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

    BPI West
    Not Confirmed
    arrow

    Omeprazole Magnesium

    Mexico

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

    arrow
    BPI West
    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 2009-163 - Rev 02

    Issue Date : 2020-11-12

    Type : Chemical

    Substance Number : 2374

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Place

    02

    Paliperidone

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

    BPI West
    Not Confirmed
    arrow

    Paliperidone

    Mexico

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-01-13

    Pay. Date : 2013-01-30

    DMF Number : 26254

    Submission : 2012-07-27

    Status : Active

    Type : II

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

    NDC Package Code : 61730-0008

    Start Marketing Date : 2011-12-05

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF VMF Others AUDIT
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    03

    Apixaban

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

    BPI West
    Not Confirmed
    arrow

    Apixaban

    Mexico

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

    arrow
    BPI West
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 30653

    Submission : 2016-06-28

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    04

    Atenolol

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

    BPI West
    Not Confirmed
    arrow

    Atenolol

    Mexico

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

    arrow
    BPI West
    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 : 7586

    Submission : 1988-07-12

    Status : Inactive

    Type : II

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

    Cetirizine Dihydrochloride

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

    BPI West
    Not Confirmed
    arrow

    Cetirizine Dihydrochloride

    Mexico

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

    arrow
    BPI West
    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 : 19432

    Submission : 2006-05-15

    Status : Inactive

    Type : II

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

    06

    Montelukast Sodium

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

    BPI West
    Not Confirmed
    arrow

    Montelukast Sodium

    Mexico

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

    arrow
    BPI West
    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 : 24747

    Submission : 2011-03-10

    Status : Inactive

    Type : II

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

    07

    Olmesartan Medoxomil

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

    BPI West
    Not Confirmed
    arrow

    Olmesartan Medoxomil

    Mexico

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

    arrow
    BPI West
    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 Inactive-api
    ✖

    Certificate Number : R0-CEP 2012-238 - Rev 01

    Issue Date : 2015-04-22

    Type : Chemical

    Substance Number : 2600

    Status : Withdrawn by Holder

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Market
    Place

    08

    Rabeprazole Sodium

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

    BPI West
    Not Confirmed
    arrow

    Rabeprazole Sodium

    Mexico

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

    arrow
    BPI West
    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 : 23907

    Submission : 2010-06-08

    Status : Inactive

    Type : II

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

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    Market
    Place

    09

    Sitagliptin Phosphate

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

    BPI West
    Not Confirmed
    arrow

    Sitagliptin Phosphate

    Mexico

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

    arrow
    BPI West
    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 : 28908

    Submission : 2015-05-15

    Status : Inactive

    Type : II

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

    10

    Tofacitinib Citrate

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

    BPI West
    Not Confirmed
    arrow

    Tofacitinib Citrate

    Mexico

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

    arrow
    BPI West
    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 : 30554

    Submission : 2016-05-19

    Status : Inactive

    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 SINTENOVO, S.A. DE C.V. and get a quotation

    SINTENOVO, S.A. DE C.V. is a supplier offers 14 products (APIs, Excipients or Intermediates).

    Find a price of Omeprazole Magnesium bulk with CEP offered by SINTENOVO, S.A. DE C.V.

    Find a price of Paliperidone bulk with DMF offered by SINTENOVO, S.A. DE C.V.

    Find a price of Apixaban bulk offered by SINTENOVO, S.A. DE C.V.

    Find a price of Atenolol bulk offered by SINTENOVO, S.A. DE C.V.

    Find a price of Cetirizine Dihydrochloride bulk offered by SINTENOVO, S.A. DE C.V.

    Find a price of Esomeprazole Sodium bulk offered by SINTENOVO, S.A. DE C.V.

    Find a price of Montelukast Sodium bulk offered by SINTENOVO, S.A. DE C.V.

    Find a price of Olmesartan Medoxomil bulk offered by SINTENOVO, S.A. DE C.V.

    Find a price of Rabeprazole Sodium bulk offered by SINTENOVO, S.A. DE C.V.

    Find a price of Sitagliptin Phosphate bulk offered by SINTENOVO, S.A. DE C.V.

    Find a price of Tofacitinib Citrate bulk offered by SINTENOVO, S.A. DE C.V.

    Find a price of FACILITIES, PERSONNEL AND OPERATING PROCEDURES AT THE NAUCALPAN (MEXICO) PLANT bulk offered by SINTENOVO, S.A. DE C.V.

    Find a price of Calcium Dobesilate bulk offered by SINTENOVO, S.A. DE C.V.

    Find a price of Roflumilast bulk offered by SINTENOVO, S.A. DE C.V.

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