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    3. /Roha Dyechem Pvt Ltd (ROHA Group)
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    Roha Dyechem Pvt Ltd (ROHA Group)

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

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    Excipients & Specialty Ingredients
    Company Overview

    About

    Roha Dyechem Pvt Ltd (ROHA Group) is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Quality Control, Stability Testing, Method Development

    Therapeutic Areas

    Rare Disease
    Metabolic
    Quick Facts
    HQ:India
    Founded:1996
    Employees:2,918
    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

    Pilot Scale
    Clinical
    Commercial Scale

    Markets Served

    North America
    Europe
    Regulatory Approvals
    Drug Approval 4NVCGK
    EMA · #APR-DUYDJLF1 · 2019-08-01
    Drug Approval 4TPKWF
    Health Canada · #APR-PM75VMKA · 2018-12-01
    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-WPQ2IGYY
    Issued: 2020-03-28
    Expires: 2025-11-11

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-76OAGBOX
    Issued: 2020-06-28
    Expires: 2025-05-09
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    Key facts about Roha Dyechem Pvt Ltd (ROHA Group)

    • Roha Dyechem Pvt Ltd (ROHA Group) is headquartered in India.
    • Roha Dyechem Pvt Ltd (ROHA Group) was founded in 1996.
    • Roha Dyechem Pvt Ltd (ROHA Group) has 2,918 employees.
    • Roha Dyechem Pvt Ltd (ROHA Group)'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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