CEP Q1 2026 Update: CEP 2.0, EDQM’s new guidelines strengthen ecosystem; Indian firms top list of CEPs issued
PharmaCompass is introducing a new regulatory update
that tracks developments in Certificates of Su
FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs
This
week, PharmaCompass brings you key highlights of the US Food and Drug Administration’s D
DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions
The
third quarter (Q3) of 2025 witnessed a steady rise in Drug Master File (DMF) submissions to the
FDA approvals drop 24% in H1 2025; GSK’s UTI med, Vertex’s non-opioid painkiller lead pack of first-in-class meds
It has been a turbulent year for the US
Food and Drug Administration (FDA), marked by reduction
FDA’s first generic approvals slump 21% in 2024; Novartis’ top seller Entresto, cancer blockbuster Tasigna lead 2024 patent cliff
A watershed moment in the journey of a drug is when it transitions from being a patented, high‐

