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  • PDE Statement Diclofenac Sodium

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    Anonymous GPLMks1p
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    Amoli Organics Pvt. Ltd. is certifying the permitted daily exposure (PDE) values for diclofenac sodium according to EMA/CHMP/CVMP/SWP guidelines. The PDE for oral exposure to rats is 0.015 mg and the PDE for dermal exposure to rats is 0.043 mg. R.K. Ahir, the manager of quality assurance at Amoli Organics, authorized and verified the information provided in the statement.

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    PDE Statement Diclofenac Sodium

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    Amoli Organics Pvt. Ltd. is certifying the permitted daily exposure (PDE) values for diclofenac sodium according to EMA/CHMP/CVMP/SWP guidelines. The PDE for oral exposure to rats is 0.015 mg and the PDE for dermal exposure to rats is 0.043 mg. R.K. Ahir, the manager of quality assurance at Amoli Organics, authorized and verified the information provided in the statement.

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    206 visualizações1 página

    PDE Statement Diclofenac Sodium

    Enviado por

    Anonymous GPLMks1p
    Amoli Organics Pvt. Ltd. is certifying the permitted daily exposure (PDE) values for diclofenac sodium according to EMA/CHMP/CVMP/SWP guidelines. The PDE for oral exposure to rats is 0.015 mg and the PDE for dermal exposure to rats is 0.043 mg. R.K. Ahir, the manager of quality assurance at Amoli Organics, authorized and verified the information provided in the statement.

    Direitos autorais:

    © All Rights Reserved
    Baixe no formato PDF, TXT ou leia online no Scribd
    Sinalizar o conteúdo como inadequado
    de 1

    Amoli Organics Pvt. Ltd.

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    Rcgd, Offlce & Flctory: Plot No.32?4,40
    Shed Area, G.I.D.C., Vapi-396 195. Gui.rat
    Phone: (0260) 240O3E3,24O0EE2 Fax: (O260) L4OI9O2
    E-mall : vapl@rmolllndla.com
    I

    -
    Date:27.O4.2OI8
    Statement regarding Permitted Dailv Exposure PDE
    lAccordine to EMA/CHMP/ CVMP/ StrIP 16943O/ 2O 12 Guidelinel

    To whom it mav concern.

    API Name: Diclofenac Sodium

    We, Amoli Organics Prrt. Ltd. hereby certi$r that the value of PDE (Permitted
    Daily Exposure) for the above mentioned substance is O.O15 mg for Rat (Oral)
    and O.O43 mg for Rat (Dermal).

    I certi$r that the above information is correct and can be verified.

    For Amoll Organics Rrt. Ltd.

    tt r(
    4"1 0

    Authorized Signatory
    R. K. Ahir
    Manager -QA
    Plot No. 32214,40 Shed Area
    G.LD.C. Vapi -396195
    Gujarat. India

    Corporat€ Office: 4O7, Dalamal House, Jamnalal Baiaj Road, Nariman Point, Mumbai'4OO 02l. INDIA
    Phone : 9l-22-22a54715116/17, 22A54n22 Fax : (O22) 22O4I4OO
    E-mail : inlo@amoliindia.com

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