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    Rakshit (Rakshit Group/Rakshit Drugs)

    CDMO
    India
    https://www.rakshitgroup.com/

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    Drug Product
    Company Overview

    About

    Rakshit (Rakshit Group/Rakshit Drugs) is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines

    Therapeutic Areas

    Rare Disease
    Metabolic
    Quick Facts
    HQ:India
    Founded:2005
    Employees:1,884
    Capabilities & Services

    Core Capabilities

    • Biologics Drug Substance
    • Biologics Drug Product
    • Biologics Manufacturing

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Prefilled Syringe
    Sterile Injectable

    Production Scales

    R&D / Pre-clinical
    Lab Scale
    Pilot Scale

    Markets Served

    North America
    Europe
    Manufacturing Facilities

    1 site worldwide

    RAKSHIT DRUGS PRIVATE LIMITED

    Unit-III, Plot No. 4, J.N.Pharma City, Thadi, Parawada,, Anakapalli, Andhra Pradesh, 531021
    View on Map

    Site Capabilities

    1 capability
    API MANUFACTURE
    Regulatory Approvals
    Drug Approval IQ7TRT
    EMA · #APR-L54UMMBC · 2018-01-01
    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-NJSE4EIG
    Issued: 2020-11-15
    Expires: 2025-02-10

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-DC9Y810K
    Issued: 2020-06-26
    Expires: 2025-09-06

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-BY6I2GA7
    Issued: 2020-12-14
    Expires: 2025-10-12

    ISO 13485:2016

    International Organization for Standardization
    Cert #: CERT-PSHO3G6S
    Issued: 2020-11-04
    Expires: 2025-01-28
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    Key facts about Rakshit (Rakshit Group/Rakshit Drugs)

    • Rakshit (Rakshit Group/Rakshit Drugs) is headquartered in India.
    • Rakshit (Rakshit Group/Rakshit Drugs) was founded in 2005.
    • Rakshit (Rakshit Group/Rakshit Drugs) has 1,884 employees.
    • Rakshit (Rakshit Group/Rakshit Drugs) has one manufacturing site listed on CDMO Hub, in Anakapalli, India.
    • Rakshit (Rakshit Group/Rakshit Drugs)'s capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.

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    CDMOs in IndiaCDMOs in AsiaBiologics Drug Substance CDMOsBiologics Drug Product CDMOsPrefilled Syringe CDMOsSterile Injectable CDMOs
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