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    Company profile for Astral SteriTech

    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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    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
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    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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    Services

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    Drug Product Manufacturing

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    Injectable / Parenteral

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    PENICILLIN GROUP INJECTABLE

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    Pharma Service : Drug Product Manufacturing

    Astral SteriTech

    ASTRAL is associated with leading national and multinational pharma companies like Pfizer, Ranbaxy, Zydus Cadila, Cipla, Orchid, Alembic, Sun Pharma, Blue Cross, Intas, Unique and Dr. Reddy's, as the contract manufacturer for their products for domestic and export ...

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    Category : Injectable / Parenteral

    Sub Category : Overview

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    Pharma Service : Drug Product Manufacturing

    PENICILLIN GROUP INJECTABLE

    ASTRAL is associated with leading national and multinational pharma companies like Pfizer, Ranbaxy, Zydus Cadila, Cipla, Orchid, Alembic, Sun Pharma, Blue Cross, Intas, Unique and Dr. Reddy's, as the contract manufacturer for their products for domestic and export segments.

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    CEPHALOSPHORIN GROUP INJECTABLE

    India
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    euroPLX 86 Munich
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    Pharma Service : Drug Product Manufacturing

    Astral SteriTech

    ASTRAL is associated with leading national and multinational pharma companies like Pfizer, Ranbaxy, Zydus Cadila, Cipla, Orchid, Alembic, Sun Pharma, Blue Cross, Intas, Unique and Dr. Reddy's, as the contract manufacturer for their products for domestic and export ...

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    Category : Injectable / Parenteral

    Sub Category : Overview

    • fda
    • EDQM
    • WHO-GMP
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    Pharma Service : Drug Product Manufacturing

    CEPHALOSPHORIN GROUP INJECTABLE

    ASTRAL is associated with leading national and multinational pharma companies like Pfizer, Ranbaxy, Zydus Cadila, Cipla, Orchid, Alembic, Sun Pharma, Blue Cross, Intas, Unique and Dr. Reddy's, as the contract manufacturer for their products for domestic and export segments.

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    03

    PENICILLIN INJECTABLE FORMULATIO...

    India
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    euroPLX 86 Munich
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    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Pharma Service : Drug Product Manufacturing

    Astral SteriTech

    Astral offers contract manufacturing for sterile antibiotic powder injectable formulations. They have independent and dedicated facilities to manufacture injectable formulations for the cephalosporin and penicillin group of products.

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    Category : Injectable / Parenteral

    Sub Category : Beta Lactams

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    Pharma Service : Drug Product Manufacturing

    PENICILLIN INJECTABLE FORMULATIONS

    Astral offers contract manufacturing for sterile antibiotic powder injectable formulations. They have independent and dedicated facilities to manufacture injectable formulations for the cephalosporin and penicillin group of products.

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    Centrient Company Banner

    Service
    Web Link

    Capabilities
    #ServicesBio

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    API & Drug Product Development

    Discover their expertise for : API & Drug Product Development

    Inspections and registrations

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    FDA

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    01

    FDA Audited

    USA
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    American Pharma Summit
    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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    02

    FDA Audited

    USA
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    American Pharma Summit
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2012-03-01

    Astral SteriTech

    City : Vadodara

    State :

    Country/Area : India

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2012-03-01

    Centrient Company Banner

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    Stock Recap
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    03

    FDA Audited

    USA
    arrow
    American Pharma Summit
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-05-11

    Astral SteriTech

    City : Vadodara

    State :

    Country/Area : India

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-05-11

    Centrient Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    04

    FDA Audited

    USA
    arrow
    American Pharma Summit
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2018-04-03

    Astral SteriTech

    City : Vadodara

    State :

    Country/Area : India

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2018-04-03

    Centrient Company Banner

    Product
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    GDUFA

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    GDUFA fees paid

    USA
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    American Pharma Summit
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    • fda
    • EDQM
    • WHO-GMP
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    Paid in : 2022

    Astral SteriTech

    API Manufacturer :

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : Astral SteriTech Private Limit...

    Business Address : 911, Gidc Makarpura Vadodara...

    FEI Number : 3005508230

    Country : India

    Paid in : 2022

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