Products and Services

Drug Product Manufacturing

Anchor and preserve your formulated and final drug product with the protective seal of AMRI SMARTSOURCING™.
 
We share your pragmatic requirements for proficiency with – and observance of – gold-standard current Good Manufacturing Practice (cGMP) regulations. From superior quality clinical formulation development to cGMP aseptic formulation and filling, our sterile and oral manufacturing processes minimize line and process loss of our customers’ valuable active pharmaceutical ingredients (APIs). 
 
We have expertise with supporting pre-clinical through commercial scale production of complex liquid-filled and lyophilized parenteral formulations. 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