About the office
APC Pharmaceuticals, LLC is a full-service pharmaceutical agency providing API and formulation solutions through the active management of a value driven, cost effective, IP savvy, and regulatory compliant dynamic network of global suppliers. Our value add is an IP centric product selection process combined with rigorous regulatory and technical review to deliver a compliant and robust process capable of delivering against the highest supply chain requirements. APC has the global resources and regulated market expertise to deliver turnkey solutions to your most challenging sourcing problems,
Capabilities
An open letter from the Managing Partner
As the US financial markets require earnings performance beyond the capabilities of internal resources, APC has provided value added solutions for both new products and older products under price pressure. Recent examples are shown below;
APC aligned with a leading generic formulator to provide a unique and non-infringing active pharmaceutical ingredient to facilitate a PIV challenge. The IP and cost requirements of the API required APC to manage a multi-country resources intensive supply chain to meet US regulatory and customer’s requirements. APC demonstrated its unique abilities to effectively manage a vertically integrated global supply chain with both new and developed relationships to meet rigorous requirements.
In another project, APC worked with a major multinational on a line-extension using proprietary ODT technology to increase compliance for a well characterized and genericized active ingredient. APC, through its frequent face to face meetings with is global development and manufacturing partners, identified a unique and valuable technology that could fill a void for this important US customer. APC worked with the partner to position and value technology in a non-traditional way to maximize value for both its supplier and customer.
In a final theme, APC is working with leading US companies to reduce costs and free resource intensive assets by offering cost effective API and formulation alternatives. APC has placed mature APIs with market leaders to reduce COGS while ensuring that reduced purchase price do not lead to higher total costs in compliance and supply chain requirements. APC worked with another ANDA holder to site transfer a sterile lyophilized product to reduce total costs in excess of 25%. This site transfer required the involvement of four organizations and APC managed the project with teleconferences, face-to-face meetings, sponsored audits, and worked through the commercial terms to the satisfaction of all parties.
APC’s worldwide resources, understanding of the US requirements, and network of global suppliers uniquely position the organization to successfully manage the growing complexity of the world’s largest pharmaceutical market. We look forward to working with you as a customer, supplier, or collaborator.
The team is led by:
John F. Kiley