Approved by regulatory agencies, including the USFDA, PMDA, EMA and KFDA, Aragen offers custom chemical synthesis solutions for key starting materials (KSMs), advanced intermediates and final APIs, to support commercial supplies of new molecules to customers.
We have demonstrated capabilities to quickly absorb customer technologies through lab familiarization batches, followed by pilot scale and custom manufacturing at plant scale. Co-location of R&D labs, pilot plants and commercial manufacturing facilities ensure seamless transfer from feasibility to commercial supply. Our facilities are designed to handle multiple products that demand a range of complex chemistries and operating conditions.
Rich experience in process development, validation and preparation of drug master files (DMFs) allows us to offer long term commercial manufacturing solutions for NCE APIs to ensure reliable supply in the early years of product launch. With cross-functional integration, we focus on operational excellence, ensuring consistency in commercial supplies in a timely and cost-effective manner.