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    Company profile for Astral SteriTech

    Centrient Pharmaceuticals-PSE
    News
    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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    About

    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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    Astral SteriTechindia-flag Flag
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    India
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    911, G.I.D.C., Makarpura, Vadodara, Gujarat, 390010
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    +91 2652638063
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    info@centrient.com
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    https://astralcorporate.com/
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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
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    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
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    Inspections and registrations

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    FDA

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    01

    FDA Audited

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    AACR Annual meeting
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    District Decision : No Action Indicated

    Inspection End Date : 2018-04-03

    Astral SteriTech

    City : Vadodara

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    Country/Area : India

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    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2018-04-03

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    02

    FDA Audited

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    AACR Annual meeting
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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-05-11

    Astral SteriTech

    City : Vadodara

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    Country/Area : India

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    District :

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    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-05-11

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    03

    FDA Audited

    USA
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    AACR Annual meeting
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2012-03-01

    Astral SteriTech

    City : Vadodara

    State :

    Country/Area : India

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    District :

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    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2012-03-01

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    04

    FDA Audited

    USA
    arrow
    AACR Annual meeting
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-01-28

    Astral SteriTech

    City : Vadodara

    State :

    Country/Area : India

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-01-28

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