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AMRI Doubles API Aseptic Mfg. Capacity

Adds a new multipurpose aseptic API line at its facility in Valladolid, Spain

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By: Kristin Brooks

Managing Editor, Contract Pharma

AMRI has more than doubled its current bulk Active Pharmaceutical Ingredient (API) aseptic manufacturing capacity with the addition of a new multipurpose aseptic line at its facility in Valladolid, Spain. This augments its aseptic API manufacturing plants in Bon Encontre and Tonneins, France.
 
The 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 need additional capacity. Supporting technologies include customized packing, seeding, milling, micronization, and processing of APIs with tailor-made specifications and control of physical properties of the final product, including particle size distribution.
 
“This investment supports our intent to serve our customers’ increasing demand for aseptic APIs linked to the need for physical control of these APIs and customized packaging configuration to improve assembling with customers’ drug product production sites,” said George Svokos, chief commercial officer, AMRI. “Our state-of-the-art lines are designed to meet requirements from pilot-scale to multi-ton scale manufacturing. Our team on the sterile lines has decades of experience creating the appropriate conditions for the media fill (aseptic process simulation) and process validation, even for very difficult-to-handle or sensitive products.”
 
AMRI also recently added an aseptic pre-filled syringe line itsmanufacturing facility in Albuquerque, NM.

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