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    Nelipak Healthcare Packaging

    CDMO
    Costa Rica
    https://www.nelipak.com/

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    Drug Product
    Regulatory, Tech Transfer & Support Services
    Company Overview

    About

    Nelipak Healthcare Packaging is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Quality Control, Stability Testing, Method Development

    Therapeutic Areas

    Immunology
    Rheumatology
    Quick Facts
    HQ:Costa Rica
    Founded:2013
    Employees:446
    Capabilities & Services

    Core Capabilities

    • Peptide Synthesis
    • Small Molecule API
    • Formulation Development

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Inhalation

    Containment Capabilities

    BSL-2 (Biosafety Level 2)

    Production Scales

    Phase II
    Clinical
    Pilot Scale

    Markets Served

    Europe
    Regulatory Approvals
    Drug Approval SGP42M
    EMA · #APR-YCKIZIL0 · 2018-11-01

    Case Studies

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

    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-7GZDTX4S
    Issued: 2020-12-13
    Expires: 2025-05-14

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-EMCTQDC9
    Issued: 2020-04-21
    Expires: 2025-05-11

    ISO 13485:2016

    International Organization for Standardization
    Cert #: CERT-PAHXPUS3
    Issued: 2020-07-04
    Expires: 2025-05-12

    MHRA GMP

    UK Medicines and Healthcare products Regulatory Agency
    Cert #: CERT-HNFE6JVG
    Issued: 2020-10-08
    Expires: 2025-07-19
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    Key facts about Nelipak Healthcare Packaging

    • Nelipak Healthcare Packaging is headquartered in Costa Rica.
    • Nelipak Healthcare Packaging was founded in 2013.
    • Nelipak Healthcare Packaging has 446 employees.
    • Nelipak Healthcare Packaging's capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.

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    Small Molecule API CDMOsFormulation Development CDMOsInhalation CDMOsBSL-2 (Biosafety Level 2) CDMOs
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