The track by which API manufacturing processes are prepared for commercial use is comparable to overlapping integrative process evaluations at commercial scale. This ensures the process is ...

Process development is the exercise of creating new and improved manufacturing methods, optimizing them in terms of time and financial efficiency while maintaining regulatory compliance and product ...

A push to reshore some drug production and progress in advanced manufacturing technologies have been prominent trends this year, industry leaders say.

The compliance process at pharmaceutical manufacturers is complicated because many still use paper-based systems to record manufacturing steps. These paper records are reviewed by FDA auditors to ...

ST. LOUIS--(BUSINESS WIRE)--The API Innovation Center (APIIC) today announced that it has been awarded funding by the Administration for Strategic Preparedness and Response’s (ASPR) Center for ...

Throughout 2025, drugmakers of all stripes have collectively poured billions of dollars into U.S. manufacturing investments. Many of those projects have centered on later stages of the production ...

SAN DIEGO--(BUSINESS WIRE)--National Resilience, Inc., a technology-focused biomanufacturing company dedicated to broadening access to complex medicines, proudly announces that its subsidiary, ...