Latest Articles

  • Executive Q&A - A Strategic Acquisition: Insights and Ideas

    An interview with Brian Morrissey, General Manager of Gaelic Laboratories, which has acquired Athlone Laboratories in a strategic deal that typifies the current pharma M&A landscape and puts all of Ireland’s Beta-Lactam manufacturing capacity under one ownership umbrella. read more

  • HPLC-Based Strategies for Impurity Profiling and Validation in Standard Drug Analysis

    The control of pharmaceutical impurities is a fundamental objective in the development of drugs, focusing on the comprehension of the chemical structures of unidentified impurities. This understanding is essential for evaluating toxicological consequences and grasping the mechanisms of formation. API-related impurities, such as degradation and interaction, can affect drug product quality, safety, and efficacy. Classifying sources of impurities is essential for analytical method development and acceptance criteria. read more

  • Horizon Lines: A Quarterly Review of NDAs – July-September 2025

    This quarterly review on New Drug Applications contains data for applications approved during the third quarter of 2025, which includes New Molecular Entities (NMEs) and new biologics. A total of 48 applications were approved by the FDA during these three months. read more

  • Quality: The Gold Standard for CDMOs - No Exceptions, No Compromises

    In today’s hyper-competitive pharmaceutical landscape, innovation, speed-to-market and cost control usually take the spotlight when selecting a contract development and manufacturing organization (CDMO). However, underneath all those metrics, a single truth remains: if quality fails, so does everything else. read more