Planning a Successful API Procurement Strategy

Abstract

[...]in November 2013, the US Congress enacted the Drug Supply Chain Security Act, giving the FDA enhanced abilities to enforce elevated trackability and product verification standards. By understanding the challenges involved in sourcing hard-to-find APIs, developing transparent and scalable manufacturer relationships either independently or with support from a qualified expert, and maintaining end-toend regulatory approval, drug developers can avoid unforeseen quality, logistical, and regulatory roadblocks. Looking for a niche API in a haystack The 505(b)(2) accelerated drug approval pathway was enacted in the 1984 Hatch-Waxman Amendments of the Federal Food, Drug, and Cosmetic Act to encourage innovation in the development of new formulations, indications, or delivery systems for existing active ingredients. For most companies, partnering with an API procurement and supply chain expert is the most cost-effective route, particularly if that expert has a strong quality assurance program and incorporates on-site audits as part of its assessment criteria.