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All compounded formulations are prepared by Olympia Pharmaceuticals under cGMP guidelines and with oversight by national and state pharmacy boards

44 This harmonization is expected to reduce the complexity and cost of maintaining exclusivity across the continent but also centralizes the risk of a single invalidity challenge toppling protection for the entire region

10.1182/blood.2019791475 152 LiuQ.ZhaiJ.KongX.WangX.WangZ.FangY.et al

Plan for the SPC Renewal in Every Major European Market Large pharmaceutical companies sometimes treat European SPC management as a routine administrative function rather than a strategic priority