PRASAD RAJE
LGM Pharma, Boca Raton, Florida, United States

Abstract

As supply chains and the programs that monitor them grow increasingly complex, more drug developers and manufacturers are seeking out strategic partnerships with modern, nimble API sourcing experts. These API partners are foundational to a continuous, compliant, and high-quality supply at a time when regulations are requiring systemwide serialization. This article will explore the important steps necessary to safeguard API security and the reasons why a strategic partnership with an API sourcing expert is key to ensuring a safe supply chain.

INTRODUCTION

You’ve got an innovative idea for a new drug therapy. Investors, business partners, and competitors are watching closely. If clinical trials are successful, you foresee scaling to commercial production and potentially impacting patients’ lives in unprecedented ways.

To get there, though, you need something very simple—and often very elusive.

My colleague Shailesh Vengurlekar, Senior VP of Regulatory and Quality Affairs at LGM Pharma, calls this critical element “supply chain security”. 

“The complexities facing today’s drug developers and manufacturers are multiplying year over year,” he says. “Designing a continuous and reliable supply chain in the midst of that complexity is one of the biggest challenges facing today’s drug innovators. You need to find a good quality manufacturer, negotiate a strong agreement, de-risk your cold chain logistics, and stay compliant with ever-evolving regulations. If you can do all that, you have a chance at a secured supply chain.”