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    J&D Biotech provides various biological and pharmaceutical products. It aims to guarantee quality products that comply with health regulations to satisfy customers. The company implements quality management systems under WHO Good Manufacturing Practices guidelines. It has certifications for manufacturing finished biological products including cytokines, vaccines, and oncology products in liquid injectable and powder for solution forms.

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    Luis Fabricio Plaza
    52 views23 pages
    J&D Biotech provides various biological and pharmaceutical products. It aims to guarantee quality products that comply with health regulations to satisfy customers. The company implements quality management systems under WHO Good Manufacturing Practices guidelines. It has certifications for manufacturing finished biological products including cytokines, vaccines, and oncology products in liquid injectable and powder for solution forms.

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    J&D Biotech provides various biological and pharmaceutical products. It aims to guarantee quality products that comply with health regulations to satisfy customers. The company implements quality management systems under WHO Good Manufacturing Practices guidelines. It has certifications for manufacturing finished biological products including cytokines, vaccines, and oncology products in liquid injectable and powder for solution forms.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    52 views23 pages

    Traducido

    Uploaded by

    Luis Fabricio Plaza
    J&D Biotech provides various biological and pharmaceutical products. It aims to guarantee quality products that comply with health regulations to satisfy customers. The company implements quality management systems under WHO Good Manufacturing Practices guidelines. It has certifications for manufacturing finished biological products including cytokines, vaccines, and oncology products in liquid injectable and powder for solution forms.

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    I&D BIOTECH

    BIOLOGICAL PLANT j&DBI0 TECH


    AND COROMA EXPAND FARMA
    PRESENTATI

    J&D BIOTECH
    QUALITY POLITICS

    J&D
    Biotech: lend services from manufacture and conditioningwind from medicines BIOLOGICAL
    for consumption human on the different shapes pharmaceutical,
    the which comply the ruletives techniques and
    from health, guaranteeing a productor from quality; pairto satisfy to
    the customers and attain his IoyaIty,with
    personal capable and motivated what search the improvementto continuous.
    Compliance of the system managementfrom quality implementado under
    the Rules from Hello good Practices from Manuinvoice (GMP ) of the WHothe report 37
    e
    A COMPANYTHISWHAT MANHAVE
    EVERWHlNCY0USTANDARDSDANDCALlf1

    Secretaría de
    Ambiente
    BIOTECHNOLOGY PLANT Ş&D BIOTECH
    -
    BIOTECHNOLOGY PLANT j&D BIOTECH
    FłECHO EN
    ECUADOR
    c«t aha
    peEuiuu
    *"*** BIOTECHNOLOGY PLANT Ş&D BIOTECH
    BiOT PRODUCTSECOLOGY
    J&D BIOTEC H
    PRODUCTS OF
    BIOTECHNOLOGY
    PROD
    BIOTE ICAL PRODUCTS
    ANDnorvid Filgrtostim Infliximtob Vcradles Pegfilgrastint
    Spray ntotol pWithto Whatmbajb0nyounit's theplwingsichey Profromctor bidieyoungicor cifbatAnd the torcMtttreithizascore.grtoWHATVID andTouttamiee.gor pWithto t
    vandus (SWITHS-CoV-two). Welltñt«aeormofromltoor, rAndfromcAndandrlmtotoidAnd. pWithtoltoinmuniforcifrom thefrom Andstin theulto the cm
    IsrrtoAndatthetto cormbaatltoneutropenia fAndbril. The Andnfismandto from Cdifferentnicto whatB\/idofdratloriedadiscattoschiIdrenor§8daatthisits bthencors to
    the recwhererin theientor dAndl toutctor digAndstivo, orl knowto, ontre ortro*
    AndsponOfat thetis tonwhatonionlyouantAnd, psorritosis. bonAndficiyou.

    products in process
    record
    VACCINES
    J&D BIOTEC H
    VACCI
    ONCOLOGY PRODUCTSICOS
    J&D BIOTEC H
    PRODUCTS
    ONCOLOGICALS
    - PORTAFOILFROM PRODUCTOSDAND ONCOLOC
    alkylatingagents
    •CarbopIatin antibioticsantitumoral
    •CispIatin •Epirubicin
    •CycIophosphamide inhibitorsdand thetopoisomerso
    •OxaIapIatino •Irinotecan(cpt— 11)
    •TemozoIomide •Etoposide
    Antimetabolicos inhibitorsdand themetosis
    •FIudarabine •DoxetaceI
    •Gemcitabine •PacIitaxeI
    •Metrotrexane

    e
    OPORTUNIDADES
    VaccinesWhatOurCovid:
    • Made inequationorwith times record, 90 days in manufacturing and deliveryto theMSP, handfromwork a
    local
    • Vaccinationsframe Basic, with periodic supply
    productuctsBiotechnology
    Possibility of local manufacture of biotechnology products madein Ecuador due to agreements
    signed with the leading manufacturer in biotechnology, possibilityfrom exportationtoLATAM
    ductuctoncological:
    rove availabilityof high—quality oncology products with a supplygrowthin real tim ourcesrsosof the MSP to attendistomore patien
    e first Pharmacyoncology withproducts personali
    Hello good Practices from Manufactuout B
    of the Organizationworld health
    (WHO of Report 37, 46 an 50.

    J&D BIOTECH
    S«4LUD PÜBLIC7I DEL ECUADOR
    REGULACIÔN. CONTROL Y PIGILANCIA SANITÁRIO

    Por cumplir las normas de Buenas Prácticas de Manulactura (BPM) vigentes en el Ecuador. establecidas
    conforme los lineamientos de la OMS para productos biológicos en el Anexo 9 del Informe N° 37.
    Anexo 2 del Informe 46 y Anexo 3 del Informe N° 50. de conformidad con la Resolución N° ARCSA-
    DE-008-201 8-JCGO. publicada mediante R.O. 257 el 07 de junio de 201S.

    Confere el presente

    CERTIFICADO DE BUENAS PRÁCTICAS DE MANUFACTURA


    No.: BPLFN-00.56

    JHON & DAVI D BIOTECHNOLOGY J&D-BIOTECH S.A.S.

    REPRESENTANTE LEGAL: CASTELLANOS TERAN IVAN kAMlRO


    No. DE ESTABLECIMIENTO: I
    No. DE PLANTA: I
    PROVINCIA : PICHINCHA
    CANTÓN: QUITO
    PARROQUIA : CARCELEN
    DIRECCIÓN: CAL LE: JUAN BARREZUETA INTERSECCIÓN: ANTONIO CASTILLO

    ÁREAS CERTIFICADAS

    El laboratorio farmacéutico está certificado para fabricar producto terminado de medicamentos


    bioló gicos de uso humano en las siguientes á reas de producció n y formas farmacéuticas:

    DILUCION PREVIO AL LÍQUIDOS ENVASADO DE


    SOLUCION
    PRODUCTOS BIOLOGICOS - CITOQUINAS fNYECTAALE

    ENVASADO DESOLIDOSPOLVO PARA

    Número de Trombe Pfigina 1/3 '*


    NUT-126
    ” J S>4LUD PÜBLIC>4 DEL ECU«4DOR
    REGULACIÓN. CONTROL Y 'IGILANCIA SANITARIO

    PRODUCTOS SOLUCIÓ N
    BIOLOGICOS - INY ECTABLE
    BIOTECNOLÓ GICOS
    l ENVASADO DE LIÇtUIDOS SOLUCIÓN
    PRODUC’TOS INYECTABLE
    BIOLOCiICOS -
    CITOQUfNAS
    1 ENVASADO DE LiQUIDOS SOLUCIÓN
    PRODUCTOS INYECTABLE
    BIOLOGICOS -
    VACUNAS
    ETIQU ETADO, SÓ LIEDS POLVO PARA
    EMPACADO Y SOLUCIÓN
    ALMACENAMIENTO INY ECTABLE
    DE PRODUCTO
    TERMINADO DE
    PRODUCTOS

    R IOTFf’ III › UNA


    Esta 1
    certificació n ETIQUETADO,
    NO INCLUYE: LÍQUIDOS
    ClTOSTÁ TICOS. SOLUCION
    CITOTÓ XICOS. HORMONAS,
    EMPACADO Y INYECTABLE
    ALMACENAMIENTO
    DE PRODUCTO
    TERMINADO DE
    Número da Trámifa
    PRODUCTOS P gtno 2/3
    /VU7-T26 BIOLOGICOS -
    ClTOQUlNAS
    ETIQUETADO, LQUIDOS SOLUCIÓN
    EMPACAOO Y INYECTABLE
    ALMACENAMIENTO
    DE PRODUCTO
    TERMINADO DE
    PRODUCTOS
    BIOLÓ GICOS -
    VACUNAS
    S>4LUD PÜBLIC>4 DEL ECU«4DOR
    REGULACIÔN. CONTROL Y k'IGILANCIA SANITÁRIO

    fNMUNOSUPRESORES, MEDICAMENTOS EN GENERAL. ANTINEOPLÁSICOS,


    RADIOFÁRMACOS, PRINCIPIOS ACTiVOS. PRODUCTOS EN IHVESTIGACIÓN.

    TRANSPORTE CERTIFICAIH3: Prmlmtos que rcquicrcn icmpcrutura de rcfrigcrució n (2°C a 8°C):


    PDP-4874.

    FECIIA DEE34ISIÓN: 2021-I0•4t6

    xcr rix soricxxe oE eEcc'Lxrz0s. ro.waec ›” › ”ic i rix sxxrrxxix


    DB. kAOrOLo¢i I2qL IEzA P2nzZ
    MANY
    THANK YO

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