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    At Seratec, pharmaceuticals are more than a science—they are our passion.

    We specialize in cutting-edge active pharmaceutical ingredients (APIs) for the treatment of rare and orphan diseases, as well as high-value small molecules. Our expertise and multidisciplinary approach enable us to design, develop, produce, and register active molecules with leading regulatory agencies.

    Learn about Who We Are

    Your CDMO for
    API Solutions

    Developing Active Pharmaceutical Ingredients, from Research to Marketing

    With over 50 years of experience, we are committed to innovation, rigour, and excellence, providing transformative API solutions, products and services for our customers and the patients we aim to serve.

    Learn about What we do

    Our Stories:
    discover our journey

    From groundbreaking research and development to successful product launches, our stories showcase our unwavering commitment to improving global healthcare. Our multidisciplinary approach and state-of-the-art facilities drive us forward, delivering impactful solutions to patients in need and defining our path to excellence.

    Read our Stories

    Well-Managed Quality: A Pharmaceutical Quality System

    The Pharmaceutical Quality System (PQS) is a management framework ensuring consistent production of high-quality products.

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    Quality at the Core of Our Strategy

    At Seratec, quality is not just a goal—it’s the foundation of everything we do and embedded throughout the entire product life cycle.

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    Orchestrating Six Systems: The FDA’s Comprehensive Approach to API Compliance

    The FDA ensures all pharmaceutical products, including APIs, meet top quality and safety standards.

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    All About the Life of an API: From Molecule to Medicine

    An active pharmaceutical ingredient (API) is a substance or mixture used in medicine production, acting as the component responsible for therapeutic effects.

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    Maria Moreno, GMP Compliance & Business Director, talking about Quality at Seratec

    Quality at Seratec plays a crucial, cross-functional role. For us, quality isn’t just a goal—it’s a driving force behind everything we do.

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    Seratec APIs: Expertise Recognized Worldwide

    Seratec specializes in areas ranging from developing active molecules to offering turnkey solutions for APIs.

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    Seratec specializes in producing cutting-edge APIs for the treatment of rare and orphan diseases, as well as high-value small molecules.

    Pioneering Innovation
    Since 1970

    After many years of formation, Seratec aims to implement 21st century GMP tools in which the keystone is combining an understanding of the product and the procedure, and their variability, in a new pharmaceutical paradigm. These ambitions are reflected in our approach to excellence in business, in which new concepts of development and manufacturing of active pharmaceutical ingredients, process validation, statistical control of processes, and the integration of the pharmaceutical quality system are organized… just to name a few.

    Read more

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