Challenge A customer needed to change from a domestically sourced API (active pharmaceutical ingredient) to an alternative, foreign-made API for a commercial product while avoiding any disruption to patient supply during the switch. Approach JHS established a Foreign...

Challenge A customer came to our team at JHS to fill GMP (Good Manufacturing Practices) batches to submit a new drug (NDA) of an ophthalmic ointment within a highly expedited timeline. The customer needed two clinical batches and three registration batches within a...