With the number of US FDA-approved drug applications reaching 112 in 2024, and the previous year marking a 20.8% surge above the historical average, drug developers continue to face growing pressure to convert approvals into timely, successful launches.
Much of this momentum is being driven by next-generation therapies, including gene therapies and orphan drugs, which accounted for a record 45 new molecular entity (NME) orphan drug approvals in 2023 alone, representing the highest quantity recorded during 2014–2023.
Following approval, speed-to-market is a key priority. Companies are under pressure to maximise market exclusivity while meeting regulatory and commercial launch timelines … and ensuring patient access to essential medicines.
At the centre of this critical post-approval phase is packaging. Far from being the final operational step, it is an essential part of launch execution; it governs how and when a therapy can be distributed, dispensed and, ultimately, accessed.
In this article, Amy Dreisbach, SPS US Director, Packaging Services, examines the crucial role that packaging plays when it comes to ensuring that essential medicines reach patients and how to effectively plan and manage the timeline of commercial packaging projects to support a successful drug launch.
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