The company’s dual drug-device development pipeline is progressing well, especially its direct sodium removal therapy for congestive heart failure.

Insights from the FDA’s Francis Godwin on how the agency came to issue a warning letter to a DuPont excipient plant and how the normally under-the-radar sector can ensure GMP compliance.

One in five drug GMP warning letters FDA issued in 2022 raised supply chain concerns. Active pharmaceutical ingredient distribution became major focal point as agency checked opioid and alcohol-based hand sanitizer supply chains. Year also featured a pair of warning letters to excipient firms, one a Mexican glycerin supplier and the other a unit of DuPont.

One in five of the drug GMP warning letters the US FDA issued in 2022 raised supply chain concerns. Active pharmaceutical ingredient distribution became a major focal point as agency checked opioid and alcohol-based hand sanitizer supply chains. The year also featured a pair of warning letters to excipient firms, one a Mexican glycerin supplier, and the other a unit of DuPont.