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    Details of Astral SteriTech's WHO-GMP Certifications aggregated by PharmaCompass

    Centrient Pharmaceuticals-PSE
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    Enforcement Report - Week of May 24, 2023

    24 May 2023

    // FDA

    Astral`s Generic Cefepime Hydrochloride Receives Approval in US

    29 Jul 2020

    // FDA

    Sagent recalls second lot of antibiotic made by Astral SteriTech

    23 Aug 2016

    // Gareth MacDonald+ IN PHARMATECHNOLOGIST

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    Astral had a humble beginning in year 1991 by Dr. Dushyant R. Patel at Vadodara, as a startup manufacturer of import substitution product, Sterile Amoxicillin Sodium - using indigenous technology developed by in house research. Subsequently by facility upgrade with high tech equipment and infrastructure, the company forward integrated into the production of sterile antibiotic powder formulations and thereby established its presence in the pharma sector as one of the state-of-the-art, independent and dedicated facility to manufacture injectable formulations for vide range of Cephalosporin and Penicillin group of products.

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    911, G.I.D.C., Makarpura, Vadodara, Gujarat, 390010
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    Enforcement Report - Week of May 24, 2023
    Enforcement Report - Week of May 24, 2023

    24 May 2023

    // FDA

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-may-24-2023-89772.pdf

    FDA
    24 May 2023
    Share Share
    Astral`s Generic Cefepime Hydrochloride Receives Approval in US
    Astral`s Generic Cefepime Hydrochloride Receives Approval in US

    29 Jul 2020

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212721

    FDA
    29 Jul 2020
    Share Share
    Sagent recalls second lot of antibiotic made by Astral SteriTech
    Sagent recalls second lot of antibiotic made by Astral SteriTech

    23 Aug 2016

    // Gareth MacDonald+ IN PHARMATECHNOLOGIST

    http://www.in-pharmatechnologist.com/Regulatory-Safety/Sagent-recalls-second-lot-of-antibiotic-made-by-Astral-SteriTech-after-rust-found-in-vial

    Gareth MacDonald+ IN PHARMATECHNOLOGIST
    23 Aug 2016
    Share Share

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