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    Betamesal Ointment - MA

    Uploaded by

    wahid
    This document is a marketing authorization certificate issued by the Directorate General of Drug Administration of Bangladesh to Incepta Pharmaceuticals Ltd. for their Betamethasone Ointment product. The certificate provides details of the product such as its trade name, generic name, strength, dosage form, manufacturing site, shelf life, storage conditions, and marketing authorization holder. It also lists several conditions for approval, including no changes without prior approval, approved manufacturing sites, packaging materials cannot be changed without approval, and pharmacovigilance reporting requirements. The marketing authorization is valid until January 12, 2024.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Betamesal Ointment - MA

    Uploaded by

    wahid
    27 views2 pages
    This document is a marketing authorization certificate issued by the Directorate General of Drug Administration of Bangladesh to Incepta Pharmaceuticals Ltd. for their Betamethasone Ointment product. The certificate provides details of the product such as its trade name, generic name, strength, dosage form, manufacturing site, shelf life, storage conditions, and marketing authorization holder. It also lists several conditions for approval, including no changes without prior approval, approved manufacturing sites, packaging materials cannot be changed without approval, and pharmacovigilance reporting requirements. The marketing authorization is valid until January 12, 2024.

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    Betamesal Ointment_MA

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    This document is a marketing authorization certificate issued by the Directorate General of Drug Administration of Bangladesh to Incepta Pharmaceuticals Ltd. for their Betamethasone Ointment product. The certificate provides details of the product such as its trade name, generic name, strength, dosage form, manufacturing site, shelf life, storage conditions, and marketing authorization holder. It also lists several conditions for approval, including no changes without prior approval, approved manufacturing sites, packaging materials cannot be changed without approval, and pharmacovigilance reporting requirements. The marketing authorization is valid until January 12, 2024.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    27 views2 pages

    Betamesal Ointment - MA

    Uploaded by

    wahid
    This document is a marketing authorization certificate issued by the Directorate General of Drug Administration of Bangladesh to Incepta Pharmaceuticals Ltd. for their Betamethasone Ointment product. The certificate provides details of the product such as its trade name, generic name, strength, dosage form, manufacturing site, shelf life, storage conditions, and marketing authorization holder. It also lists several conditions for approval, including no changes without prior approval, approved manufacturing sites, packaging materials cannot be changed without approval, and pharmacovigilance reporting requirements. The marketing authorization is valid until January 12, 2024.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

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    Government of the People's Republic of Brngladesh
    Directorrte Getreral of Drug Administrstion
    Ministry of Health and Family Welfare
    Mohakhali, Dhaka- I 2 I 2.
    www.dgda-gov.bd

    Memo No: DcDNMA-366t20t714* o*q .Q!...t.Q)-tzoz\


    To
    Incepta Phamaceuticals Ltd.,
    Dhamrai Unit, Dhak4 Bangladesh
    Subjcct: Certilicrte for Merkcting Authoriz.tion of Drug/Biologicrls/Vrccincs,/Medicinal Devices.

    ln response to application, reference number IPLDU/PR/OO7T2O23 for Marketing aulhorization


    ofthe following product, trcDA hereby inform you that the evaluation ofthe application has been
    completed.

    Trade name : Betrmesrl Ointment

    Generic Nam{s) : Betamethasone BP/Ph. Eur. + Salicylic Acid BP/Ph.Eur.

    Strength(s) per dosage unit : (0.059n + 3gm!l00gm

    Dosage form : Oinunent

    Manufacturing Site : Incepta Pharmaceuticals Ltd., Dharnrai Unit, Dhak4


    Bangladesh
    f
    Shelflife :2 years
    Storage Condition : Do not store above 30oC

    Name ofmarketing authorization : Incepta Pharmaceuticals Ltd., Dhamrai Unit, Dhak4


    holder Bangladesh

    Tlre appmval of marketing authorization has been given subject to the conditions in this
    c€rtificate and it's attachments. This certificate and its attachments constitute the marketing
    authorization. The details ofthis authorization are as follows.
    Marketing Authorizalion Number : MA No. 35G136071
    Date of Marketing Authorization . 0 I, JAN 202i.

    Expiry date of Marketing Authorization : l2-01L202t

    llI

    fU"io" Yousuf
    * I tttl
    Df,.iAK. Di
    Adm
    i lrH

    lyectonte
    Licensi uthority (Drugs)
    R
    G ort. of the People S lc of Bangl adesh
    6
    x
    )SBr ]rr$r,0$r.]ff{0r.lattil..r+it{.}r{tt r4$t r$i& r+(lt ,$'i{t r*rBt

    Conditions which appiy to this approval are as follows:

    The product(s) must conform with all the details provided in your application and as
    modified in subsequent correspondence.
    No changes may be made to the prcduct without prior approval ofthe Liccnsing Authority
    (Drugs).
    The approved sites of manufacture are stated in Attachment -l (Annexure-UAnnexure -II
    approved formulation).
    The Approved shelfJife stated above and in attachment 2 (stability study report), may be
    changed having the prior approval oflicensing Authority.
    The only Product Information (PI) that may be supplied with or for this product must be
    the PI that is approved. Attachment 3 is a copy ofthe approved Pl (Product Information).
    Text /design of packaging materials csn not be changed without approval. Approved
    packaging materials should be attached (Attachment-4).
    The Product lnformation (Pl) may not be altered without prior appmval of Licensing
    Authority, except for safety updates that further restrict use of the product. Any such
    safety-related changes must be notified to the Licensing Authority within five days of
    making the changes.
    The approved product price has to be pnntod on the packaging Materials clearly. Over
    stamping/price tempering/price sticker on printed price is not allowed price certificate
    should be attached (Attachmert-5).
    Pharmacovigilance ofrhis product has to be conducted on regrrlar basis & report has to be
    submitted to DGDA if any adverse efrect is nd identified or rcceived nil report has to be
    submitted to DGDA.

    x x
    .
    tssr.l+{tr ' ,$'{tr rc{t{ r$i*r )lior rti*r )crl{ lart0( *nilr }li.tl( )0.*{,$ict,nll}( r+{t{ r0{tr.

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