Aragen is a partner of choice for small molecule manufacturing. Equipped with modern facilities, accredited by leading regulatory agencies, and supported by world class quality systems, we have deep manufacturing, analytical and regulatory experience. Requisite capacity and capabilities enable us to manufacture key starting materials (KSMs), advanced intermediates and active pharmaceutical ingredients (APIs) to support customer requirements from clinical through commercial launch. Our expertise in chemistry, manufacturing and controls (CMC) and knowledge of global regulatory requirements ensures successful dossier submission and approval.
Well-positioned to support commercial quantity requirements of KSMs, intermediates and APIs, for innovator and generic pharma, agrochemical and other chemical industries.
15+ years of manufacturing experience in commercial APIs, backed by rich experience in process development, validations and drug master filing.
Drug substance, drug product, analytical and performance chemicals solutions to advance customer programs.
Reliable and reproducible analytical data to support speedy filing for regulatory approval.
Aligning EHS and sustainability initiatives with strategic business value.
