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26 Pharmaceutical Technology ® Trends in Formulation 2023 eBook PharmTech.com ROMANR - STOCK.ADOBE.COM T he production of safe and effective medi- cines requires access to reliable manufactur- ers of APIs. However, increasing pressure to reduce market prices of drugs has created deeper challenges for API sourcing organizations, of- ten leading them to consider lower quality and less reliable suppliers. This is a short-sighted approach. Particularly as global quality standards become more harmonized, there are now higher expectations across the globe. And with COVID-19, reliability has also become a top-of-mind topic for manufacturers and healthcare systems. The best approach to overcoming these challenges is finding a balance in the total cost of manufactur- ing and selling medicines, also referred to as total cost of ownership, with the right quality API at the right (not cheapest) price. Increasing cost pressures leading to price-driven outsourcing While the formulation of drug products with inex- pensive APIs that meet minimum quality standards can lead to surprises, drug shortages due to the clo- sure of API manufacturing plants that fail regulatory inspections can have profound consequences for pa- tients. The recall of contaminated drug products may result in both drug shortages impacting patients and have significant reputation and financial damage on manufacturers. Such negative outcomes are often as- sociated with API suppliers who meet the lowest com- monly acceptable quality standards in the industry and who are overtly unreliable, albeit the cheapest. In the long run, securing reliable, high-qualit y, well-managed APIs from suppliers committed to meet- ing best-in-class quality standards and regulator y Optimizing the Total Cost of Ownership for APIs Andrew Badrot, CEO, C 2 Pharma All members of the pharmaceutical supply chain must implement reliable sourcing and manufacturing strategies that balance quality and costs to ensure the uninterrupted supply of high-quality medicines to patients worldwide.