Pharmaceutical micronization, the process of reducing particle size to the micrometer scale, has become a critical technology for improving drug solubility, bioavailability, and formulation flexibility. Catalent, a global leader in drug development and delivery solutions, offers world-class micronization services through its specialized facilities in Dartford, UK, and Malvern, Pennsylvania, USA, supported by a network of forward processing commercial-scale manufacturing sites. This article explores the advantages of micronization and how Catalent’s integrated approach accelerates drug development.
The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.
The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.
The Leadership Summit will bring senior pharma executives together to discuss supply chain resilience, medicine security, and manufacturing capacity amid growing geopolitical fragmentation.
This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.