Gaining the licence from the US Drug Enforcement Agency (DEA) allows Ricerca to prepare controlled bulk active pharmaceutical ingredients (API) for Phase I to II trials.
Rich Donaldson, vice president of chemical development at Ricerca, said the licence will allow the company “to move forward on clients’ R&D projects that require a DEA license with no delay”.
When granting licenses the DEA considers documented accountability of material usage and disposal, secure storage and compliance with ICH Q7A.