Samchundang Pharm gains FDA feedback on oral semaglutide generic path

Samchundang Pharm received FDA Pre-ANDA guidance on its oral semaglutide generic development, reducing regulatory uncertainty though final approval remains subject to subsequent ANDA review. The South Korean manufacturer has already signed supply contracts in the US and Europe and is pursuing regulatory consultations in Japan and the Middle East. If you're building the supply chain for GLP-1 generics in the US, Samchundang's cleared pathway tells you the FDA will approve oral semaglutide copies - and a Korean manufacturer is already locking up distribution, meaning you need customers before the price floor collapses. Pre-ANDA guidance is the signal that approval is on track; ANDA filing is imminent.