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  • Formula of K-Omegasqua

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    Ririe Ghanez
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    This document is an application form for marketing authorization for the product K-OMEGA Softgel Capsule. It provides information about the local distributor, holder of the marketing authorization, and manufacturer of the product. It also lists the qualitative and quantitative formula of the active and excipient ingredients in each softgel capsule, including Omega-3 EPA/DHA, Squalene Oil, Vitamin E, Gelatin, Glycerin, Methyl Paraben, Ethyl Vanilline, and Purified Water. The active ingredients are Omega-3 EPA at 40% and DHA at 30% for a total of 500mg per capsule. The remaining excipients make up the capsule shell.

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    This document is an application form for marketing authorization for the product K-OMEGA Softgel Capsule. It provides information about the local distributor, holder of the marketing authorization, and manufacturer of the product. It also lists the qualitative and quantitative formula of the active and excipient ingredients in each softgel capsule, including Omega-3 EPA/DHA, Squalene Oil, Vitamin E, Gelatin, Glycerin, Methyl Paraben, Ethyl Vanilline, and Purified Water. The active ingredients are Omega-3 EPA at 40% and DHA at 30% for a total of 500mg per capsule. The remaining excipients make up the capsule shell.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    39 views1 page

    Formula of K-Omegasqua

    Uploaded by

    Ririe Ghanez
    This document is an application form for marketing authorization for the product K-OMEGA Softgel Capsule. It provides information about the local distributor, holder of the marketing authorization, and manufacturer of the product. It also lists the qualitative and quantitative formula of the active and excipient ingredients in each softgel capsule, including Omega-3 EPA/DHA, Squalene Oil, Vitamin E, Gelatin, Glycerin, Methyl Paraben, Ethyl Vanilline, and Purified Water. The active ingredients are Omega-3 EPA at 40% and DHA at 30% for a total of 500mg per capsule. The remaining excipients make up the capsule shell.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 1

    ''AnnexureI

    APPLICATION FORM F'OR MARKETING AUTHORIZATION

    1. Applicant (Manufacturer, Local distributor, Holder'ol'the Marketing Authorization ) :

    Local Distributor
    Name AngelBossGroupCo.Ltd
    Address No. 79Bc,KampucheaKrornSt.(128),MorroromPhnomPenlr,
    Kingdomof Carnbodia
    Phone 85523 883 817
    Fax 8s5 23 88r 785

    Holder of the Marketing Authorization


    Name : K-Link InternationalSdn Bhd
    Address WismaK-Link,45 Jalan Kr"rchai
    Maju2, Off JalanKuchail,arna
    58200KualaLumpur,Malaysia
    Plrone 60379482333
    Fax 60319482338

    2, Manufacturer:
    Name PT.Nova ClremieUtarna
    Address Jl. Suci Km.24, Cijantung,.lakartaTimur, DKI Jakarta,Indonesia
    Phone +62218400784 '
    Fax +622t 84i I 173

    3. Information on the product..

    Commercialname : K-OMEGASeUA
    Galenicform : Softgelcapsule

    4. Qualitative and quantitative formula

    a. Active I redient
    No. Approved Name LocaUlltell-known Colour/Form Quantityper
    Name dosageform
    ber soflsel cunsule)
    Omega3 - EPA 40%I Omega3 Clear,yellow liquid 500 mg
    DHA 30% IDHA3O%-EPA40Yo
    2. Squalene
    Oil Squalene
    Oil Clearliquid, almost 497 mg
    colourless,
    slightly
    odour
    3. VitaminE (Natural) VitaminE Brownliquidoil 3mg

    b. Exci
    No. Approved Name Purposeforinclusion Quantity per dosageform
    ber softsel csnsu.le)
    Gelatin C a p s u l es h e l l 600 ms
    2. Gl yc er in Plasticizers in capsuleshell I JJ nl g
    Methvl Paraben Preservativein capsuleshell 0.33 ms
    A
    Eth yl V anilline Flavorin cansuleshell 0.33 ma
    Purified water Processing air to rnakethe shell 380 ms

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