Recent FDA actions offer long-awaited clarity on what constitutes a ‘minor change’ to solid oral OTC dosage forms, providing manufacturers with a clearer pathway for certain modifications while ...

How integrated pharmaceutical manufacturing helps CDMOs simplify scale-up, reduce complexity, and move from raw materials to finished dosage forms faster.

Forma Life Sciences, Inc. today announced its launch as an independent, operator-owned contract development and manufacturing ...

This article explores current OSD development and manufacturing trends from a CDMO perspective, including the evolution of outsourcing, emerging technologies, manufacturing advancements and industry ...

The U.S. Food and Drug Administration (FDA) issued final guidance on “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms,” which provides advice on conducting bioequivalence (BE) ...

Piramal Pharma Solutions and NewAmsterdam Pharma Company will be opening a dedicated oral solid dosage form suite at Piramal’s facility in Sellersville. The Sellersville site is one of Piramal Pharma ...