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  • Vietnam Dossier Status-2023: SL No Brand Name Local Name Strength Pack Size Status Remarks

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    Mohammad Nazir Uddin
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    This document provides a status update on 8 pharmaceutical products in Vietnam. It includes the brand name, local name, strength, pack size, and status for each product. Most products have been sent to the Head Office, while some need additional documentation or validation before regulatory approval. In summary, the dossier outlines pharmaceutical reference data and provides a status update for drug products being developed in Vietnam.

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    This document provides a status update on 8 pharmaceutical products in Vietnam. It includes the brand name, local name, strength, pack size, and status for each product. Most products have been sent to the Head Office, while some need additional documentation or validation before regulatory approval. In summary, the dossier outlines pharmaceutical reference data and provides a status update for drug products being developed in Vietnam.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
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    9 views1 page

    Vietnam Dossier Status-2023: SL No Brand Name Local Name Strength Pack Size Status Remarks

    Uploaded by

    Mohammad Nazir Uddin
    This document provides a status update on 8 pharmaceutical products in Vietnam. It includes the brand name, local name, strength, pack size, and status for each product. Most products have been sent to the Head Office, while some need additional documentation or validation before regulatory approval. In summary, the dossier outlines pharmaceutical reference data and provides a status update for drug products being developed in Vietnam.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 1

    Vietnam Dossier Status-2023

    Sl No Brand name Local Name Strength Pack size Status Remarks


    01 Tamban Syrup Amsiv Syrup Ambroxol 15mg /5 ml Syrup Box of 100ml (PET bottle) Sent to HO 15.03.2022
    02 Odeban Syrup Ebatrol Syrup Ebastine 5 mg/5 ml Syrup Box of 50ml (PET bottle) Sent to HO 11.01.2022
    03 Dinbat 5 Tablet Dapagard 5 tab Dapagliflozine 5 mg tablet Box of x 10 tablets Sent to HO 21.10.21
    04 Dinbat 10 Tablet Dapagard 10 tab Dapagliflozine 10 mg tablet Box of 3 x 10 tablets Sent to HO 21.10.21
    Need proper P-Part Completed,
    05 Bitvia Syrup Meeera Syrup Butamirate citrate7.5 mg/5 ml Box of 100ml (PET bottle) DMF Except Assay &
    Dissolution Validation
    Need proper P-Part Completed,
    Desohep 30
    06 Dexalax 30 Cap Dexlansoprazole 30 mg capsule Box of 3 x10 capsules DMF Except Dissolution
    Capsule
    Validation
    Dexalax 30 Cap Need proper P-Part Completed,
    Desohep 60
    07 Dexlansoprazole 60 mg capsule Box of 3 x 10 capsules DMF Except Assay &
    Capsule
    Dissolution Validation
    Need proper P-Part Completed,
    08 -- Scabo 6 tablet Ivermactine 6 mg tablet Box of 2 x 10 tablets DMF Except Assay &
    Dissolution Validation

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