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Piramal Pharma Solutions, 18655 Krause St, Riverview, MI 48193, USA
Riverview is recognized as a world-class facility renowned for its expertise in drug substance manufacturing, with over 60 years of experience in delivering high-potency APIs (HPAPIs). The site has excelled in advancing several HPAPIs from early development to commercial manufacture, solidifying its position as a global leader in API and HPAPI development, as well as GMP manufacturing for complex NCEs.
The site has been fully inspected by numerous regulatory agencies, including USFDA, Health Canada, PMDA Japan, COFEPRIS Mexico, MFDS Korea, TGA Australia, and the Russian Ministry of Health.
We provide an array of services, including process/route selection, isolation and synthesis of impurities, spike and purge studies, process safety studies and process modelling studies using Dynochem®. We also offer particle size reduction along with solid-state characterization (XRPD, DSC, TGA).