GMP CUSTOM MANUFACTURING
As a highly qualified and experienced excipient manufacturer, A&C can provide GMP custom manufacturing, custom formulations or can duplicate your current processes and formulations for all raw materials, guaranteeing quality as well as technical and product assurance.
Once the A&C developed process is completed and validated, the product is put on a long-term stability testing. The product is then manufactured, packaged and released under full GMP compliance.
Custom manufacturing of excipients, buffers and process solutions for our global client base has allowed A&C to rapidly resolve our customers’ challenges in either the preclinical phase, in clinical trial phases I, II or III, or in commercial finished drug manufacturing. With over five decades of experience as an excipient manufacturer, A&C has the technical, regulatory and quality expertise to resolve a wide variety of our customers’ GMP issues by providing a wide range of tailored solutions, including GMP custom manufacturing of excipients and raw materials.
A&C has been successfully custom manufacturing a multiplicity of raw materials including solvents, preservatives, lubricants, binders, antioxidants, process solutions and buffers and a select number of APIs which are all manufactured under GMP and meet the required governing monographs (USP/NF/EP/BP/JP) or multi-compendial grade.
All products also enter into A&C’s Quality and Supply Chain management system. Since quality, transparency and change control are crucial for us and for our clients, all of our processes are designed to keep customers appropriately notified of significant changes. To further limit our customers’ risk, A&C works with multiple raw materials suppliers to have secondary sources approved where possible.