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BioDuro-Sundia

About BioDuro-Sundia

BioDuro-Sundia, an Advent International portfolio company is a trusted, leading contract research development, and manufacturing organization (CRDMO) for over 27 years. We provide our biotech and pharmaceutical partners with fully integrated services to support their efforts from target identification through to commercial drug product manufacturing. The company is based in the US with operations in China, totaling 2,500 employees and 9 global sites across 6 cities. 

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Certifications
  • GMP
    GMP
  • ISO
    ISO
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Sales Markets
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Categories
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  • US
  • 2018
    On CPHI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Company types
Contract Service
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Contact info
  • Website
  • 9601 Jeronimo Road, CA 92618, Irvine, CA, United States
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Meet us at

CPHI North America 2024

Pennsylvania Convention Center, Philadelphia
07 May 2024 - 09 May 2024
View Exhibitor Profile

CPHI Milan 2024

Fiera Milano, Italy
08 Oct 2024 - 10 Oct 2024
View Exhibitor Profile

Products from BioDuro-Sundia (5)

  • Drug Product Manufacturing

    Product Drug Product Manufacturing

    BioDuro-Sundia's Drug Product manufacturing services support clinical and commercial scale GMP production for a comprehensive range of oral solid dosage forms, including: solid, liquid, and semi solid dosage forms. This includes fully-audited manufacturing facilities (FDA and other regulators) with excepti...
  • Drug Substance

    Product Drug Substance

    BioDuro-Sundia’s Drug Substance manufacturing services support production of small molecule APIs, RSMs and intermediates--both GMP and non-GMP .  We provide a full range of production scale, supporting all stages of drug substance development through IND submission.  Fully integrated CMC ser...
  • Process Development

    Product Process Development

    BioDuro-Sundia’s process development services support drug substance production,  providing an efficient path to manufacture API or intermediates. Our extensive services support production of API for GLP toxicology studies, IND-enabling studies, clinical studies, and commercialization efforts. qq...
  • Formulation Development

    Product Formulation Development

    BioDuro-Sundia holds more than 25 years of experience formulating poor solubility and  poor permeability drugs for the clinical studies. Our comprehensive suite of advanced formulation technologies and extensive scientific know-how supports >95% of marketed dosage form...
  • Analytical Development

    Product Analytical Development

    BioDuro-Sundia’s Analytical Testing team offers high quality analytical services including method development and validation, qualification of reference standards, testing and release studies, stability studies, and CMC dossier preparation services. ...

BioDuro-Sundia Resources (1)