Tonghe Pharma: Mirabegron Active Pharmaceutical Ingredient Receives FDA Registration Approval Letter

Tonghe Pharmaceutical announced that the company recently received a DMF No Further Comments Letter from the U.S. Food and Drug Administration for the registration approval of Mirabegron active pharmaceutical ingredient, with the drug master file number 031661. The NFC Letter indicates that the FDA has completed the technical review, meeting the ANDA application requirements for associated formulation customers, which is beneficial for the company's expansion into international markets.