Supply Chain

As a manufacturer of life saving drugs, how confident are you that your supply chain of API, intermediates, finished products, excipients, and other critical components necessary to manufacture your products can meet both today and your future needs?

Do you purchase from 1 supplier, do you have qualified backups that you could turn to if need be?  How long would it take to identify, qualify, and receive materials from a new supplier?

Do you purchase from a distributor?  How do you know who your distributor is purchasing their products from, and will the distributor inform you if they switch suppliers?

Michael Mezher, RAPS 2020, wrote an interesting piece concerning FDA monitoring of 20 drugs that are at risk of shortage because of the Coronavirus, as the drugs are made in or produced solely from APIs sourced from China.