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  • 3.2.P.4.4 Justification of Specs

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    Madhu Gajulapalli
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    The document discusses specifications for Bortezomib for Injection 3.5 mg and presents certificates of analysis for excipient manufacturers. Certificates of analysis are provided on pages 1 through 4 for excipient manufacturers to justify specifications.

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    The document discusses specifications for Bortezomib for Injection 3.5 mg and presents certificates of analysis for excipient manufacturers. Certificates of analysis are provided on pages 1 through 4 for excipient manufacturers to justify specifications.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOCX, PDF, TXT or read online from Scribd
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    Download as docx, pdf, or txt
    64 views4 pages

    3.2.P.4.4 Justification of Specs

    Uploaded by

    Madhu Gajulapalli
    The document discusses specifications for Bortezomib for Injection 3.5 mg and presents certificates of analysis for excipient manufacturers. Certificates of analysis are provided on pages 1 through 4 for excipient manufacturers to justify specifications.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as docx, pdf, or txt
    of 4

    BORTETHER 3.5 Bortezomib for Injection 3.

    5 mg CTD Module 3: Quality

    3.2. P.4.4

    Justification of Specifications

    Certificates of analysis for the Excipients manufacturers are presented in the following pages.

    Sec-3.2.P.4

    Page 1 of 4

    BORTETHER 3.5 Bortezomib for Injection 3.5 mg CTD Module 3: Quality Mannitol Mfg.COA

    Sec-3.2.P.4

    Page 2 of 4

    BORTETHER 3.5 Bortezomib for Injection 3.5 mg CTD Module 3: Quality

    Sec-3.2.P.4

    Page 3 of 4

    BORTETHER 3.5 Bortezomib for Injection 3.5 mg CTD Module 3: Quality

    Sec-3.2.P.4

    Page 4 of 4

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