AMRI Doubles Bulk API Aseptic Manufacturing Capacity
AMRI, a contract research, development, and manufacturing organization, has more than doubled its current bulk active pharmaceutical ingredient (API) aseptic manufacturing capacity through the addition of a new multipurpose aseptic API line at its facility in Valladolid, Spain.
AMRI also has aseptic API manufacturing plants in Bon Encontre and Tonneins, France.
The company says its sterilization capability can be integrated with API production or operate as a separate outsourced step for customers that do not have bulk sterile facilities or who may need additional capacity. Supported by a range of supporting technologies, including customized packing, seeding, milling, micronization, AMRI notes that this new line ensures aseptic processing of APIs with tailor-made specifications and control of the physical properties of the final product, including particle-size distribution. Further integration is offered with AMRI’s Drug Product capabilities.
Additionally, AMRI recently announced the addition of an aseptic pre-filled syringe line at the company’s manufacturing facility in Albuquerque, New Mexico.