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    Novaphene Specialities Pvt. Ltd.

    CDMO
    India
    https://novaphene.com/

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    Drug Product
    Excipients & Specialty Ingredients
    Company Overview

    About

    Novaphene Specialities Pvt. Ltd. is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Gene Therapy, Cell Therapy, mRNA

    Therapeutic Areas

    Oncology
    Hematology
    Quick Facts
    HQ:India
    Founded:2006
    Employees:911
    Capabilities & Services

    Core Capabilities

    • Oral Solid Dose
    • Solid Dose Manufacturing
    • Formulation Development

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Lyophilized (Freeze-Dried)
    Sterile Injectable

    Containment Capabilities

    Cytotoxic / ADC Handling

    Production Scales

    Commercial Scale
    Large Scale (Metric Ton+)

    Markets Served

    North America
    Regulatory Approvals
    Drug Approval GWOXC8
    EMA · #APR-R7ARN468 · 2019-11-01
    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-382WN1AB
    Issued: 2020-12-06
    Expires: 2025-03-25

    ISO 13485:2016

    International Organization for Standardization
    Cert #: CERT-8RB8FDO0
    Issued: 2020-02-09
    Expires: 2025-03-21

    Health Canada GMP

    Health Canada
    Cert #: CERT-36IZY4BP
    Issued: 2020-01-26
    Expires: 2025-12-11
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    Key facts about Novaphene Specialities Pvt. Ltd.

    • Novaphene Specialities Pvt. Ltd. is headquartered in India.
    • Novaphene Specialities Pvt. Ltd. was founded in 2006.
    • Novaphene Specialities Pvt. Ltd. has 911 employees.
    • Novaphene Specialities Pvt. Ltd.'s capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.

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    CDMOs in IndiaCDMOs in AsiaOral Solid Dose CDMOsFormulation Development CDMOsLyophilized (Freeze-Dried) CDMOsSterile Injectable CDMOsCytotoxic / ADC Handling CDMOs
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