Jiangxi Synergy Pharmaceutical (300636.SZ): The raw material drug Carriage Ligand was granted a registration approval letter by the US FDA.

Jiangxi Synergy Pharmaceutical (300636.SZ) announced that the company has recently received the First Adequate Letter (FA Letter) from the U.S. Food and Drug Administration (FDA) for the registration approval of the active pharmaceutical ingredient Canagliflozin. Canagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, mainly used clinically to treat type 2 diabetes. The approval of the FA Letter for Canagliflozin product by the FDA indicates that the FDA has completed the technical review of the company's Canagliflozin active pharmaceutical ingredient Drug Master File (DMF) and can meet the requirements for Abbreviated New Drug Application (ANDA) submission by related formulation customers. The successful technical review of Canagliflozin active pharmaceutical ingredient will help the company expand its market, develop new customers, and positively impact the company's further expansion into international markets.