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    Softigel (by Procaps Group)

    CDMO
    Brazil
    https://www.softigel.com/

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    Drug Product
    Company Overview

    About

    Softigel (by Procaps Group) is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization

    Therapeutic Areas

    Cardiovascular
    Endocrinology
    Quick Facts
    HQ:Brazil
    Founded:1992
    Employees:331
    Capabilities & Services

    Core Capabilities

    • Sterile Injectable
    • Sterile Fill/Finish
    • Fill/Finish (Vials)

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Cartridge / Pen

    Containment Capabilities

    OEB 5 (≤1 µg/m³)
    Cytotoxic / ADC Handling

    Production Scales

    R&D / Pre-clinical
    Lab Scale
    Pilot Scale

    Markets Served

    Asia-Pacific
    Regulatory Approvals
    Drug Approval DRLPIU
    FDA · #APR-AHFVBQLX · 2020-07-01
    Drug Approval RDURN5
    FDA · #APR-PFB98B67 · 2020-02-01

    Case Studies

    0 published case studies showcasing past projects, challenges and outcomes.

    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-DSA5QT2K
    Issued: 2020-09-02
    Expires: 2025-03-02

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-M5FVV19P
    Issued: 2020-07-08
    Expires: 2025-11-10
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    Key facts about Softigel (by Procaps Group)

    • Softigel (by Procaps Group) is headquartered in Brazil.
    • Softigel (by Procaps Group) was founded in 1992.
    • Softigel (by Procaps Group) has 331 employees.
    • Softigel (by Procaps Group)'s capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).

    Find CDMOs like Softigel (by Procaps Group)

    Directory pages this company appears in, each with the full list of matching manufacturers.

    Sterile Injectable CDMOsFill-Finish CDMOsFill/Finish (Vials) CDMOsCartridge / Pen CDMOsOEB 5 (≤1 µg/m³) CDMOsCytotoxic / ADC Handling CDMOs
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