Jiangxi Tonghe Pharmaceutical Co., Ltd. announced that it recently received a registration approval letter from the U.S. Food and Drug Administration for its Mirabegron active pharmaceutical ingredient, with Drug Master File number 031661. Mirabegron is a selective beta-3 adrenergic receptor agonist used to treat overactive bladder. This approval indicates that the FDA has completed the technical review of the API's DMF file, which can meet the ANDA filing requirements of associated formulation customers. The company stated that this will help expand the market, develop customers, and further grow its international business, but also noted that sales of related products are susceptible to factors such as changes in the market environment and exchange rate fluctuations.
Jiangxi Synergy Pharmaceutical Co LtdFDA approval of Mirabegron API enables market expansion and customer development.
