Products and Services

Drug Product Manufacturing

In the area of Drug Product Manufacturing, AMRI provides customers with a single source to address their sterile fill/finish needs from formulation complete to commercial supply.
 
We provide expertise and services for the aseptic formulation development and manufacture of small batches for early stage clinical trials; process development and manufacture of medium-scale clinical product; and commercial-scale fill/finish.
 
We specialize in vial and pre-filled syringe manufacturing and have lyophilization capabilities for vials. AMRI has the capability to perform small batch manufacturing, but has the capacity to perform filling for larger batches to support Phase III, registration batches, and commercial.
 
In the area of Clinical Formulation development, our core competencies include Pre-Formulation Development, Formulation Matrix Development, Dosage Form Development and Lyophilization Development. 
 
In the area of Aseptic Fill and Finish, our core competencies include Biologics and Small Molecules, Viscous biopolymers, Suspensions, Liposomes, micelles and other nanoparticles, Microfluidization and High Shear Homogenization, Extrusion and Controlled Substance up to Schedule 2. 
 
 


View Aseptic Fill and Finish flyer

View our cGMP Liposomal Formulation Fill Finish flyer

Download our Aseptic Manufacturing Case Studies