Development

Sundia’s drug development program offers a
"one-stop shop" service platform

Drug Development

Sundia offers comprehensive CMC services, ranging from scale-up, process R&D, formulation development and analytical method development. Sundia provides innovative solutions that meet clients' project needs, including assisting clients in preparing CMC documentation that is compliant to global GMP standards

  • Process

    Sundia provides a broad scope of drug development solutions, ranging from route design, process improvement and optimization, process scale-up, technology transfer from research to commercial scale, and multi-gram to multi-ton manufacturing of Active Pharmaceutical Ingredients (APIs) and intermediates in compliance to cGMP guidelines. Our relentless focus on providing innovative, flexible and cost-effective solutions will enable you to maximize your efficiency and shorten your lead times.

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  • Analytical

    Sundia’s Analytical research and development (ARD) team offers high-quality analytical services including method development and validation, qualification of reference standards, testing and release studies, stability studies, CMC dossier preparation services. Our team has collaborated with pharmaceutical companies and successfully obtained many U.S.FDA and China FDA IND/ANDA approvals. Sundia is committed to delivering cost effective and high quality analytical services to clients.

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  • Formulation

    Sundia’s Formulation research and development team provides a full range of service modules including pre-formulation research, technical transfer, formulation development, and product registration. Through "One-Stop Shop" formulation and product development platform, our team works seamlessly with the Process Development, Analytical and DMPK teams to help accelerate your drug candidates quickly from the pre-clinical stage to IND/NDA/ANDA filings.

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  • Manufacturing

    In July 2014, we commenced operations of our pilot plant which further expanded our CRO services to multi-ton scale. Our pilot plant is located in Taicang Chemical Industrial Park, which is approximately 75 km from Sundia’s Shanghai headquarters. The state-of-the-art facility provides highest quality and EHS compliant non GMP production. The facility has been qualify and audited by a number of top tier global pharma for non GMP material production.

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