API

Understanding disruptions to the antibiotic supply resulting from COVID-19

The COVID-19 pandemic has highlighted vulnerabilities within the generic drug supply chain. To minimize the effects of antibiotic API supply disruptions, it is important to understand the underlying reasons for shortages to then identify the best-fit manufacturing partners.   The COVID-19 pandemic has disrupted the global drug supply, as manufacturing companies contend with government-mandated or […]

Drug development challenge: Managing CMC submissions

In the era of Breakthrough Therapy and Fast Track drug designations, chemistry, manufacturing and controls (CMC) submissions can cause delays to bring a drug to market, said Drew Barlow, vice president, regulatory affairs at Syner-G Pharma Consulting.  Companies need to provide enough information to satisfy the regulatory requirements while recognizing that providing too much information early will […]