Jiangxi Tonghe Pharmaceutical Co., Ltd. recently received GMP compliance certificates for the active pharmaceutical ingredients mirabegron and empagliflozin from Australia's Therapeutic Goods Administration. This marks the company's first time passing a TGA GMP certification. The certificate number is MI-2025-CE-02875-1, valid until August 3, 2028. Mirabegron is used to treat overactive bladder, and empagliflozin is used to treat type 2 diabetes. The certification indicates that the company's quality system and production environment facilities have been recognized by the TGA, which will help promote international market development and gain access to the Australian market. The company also noted that international sales may be affected by factors such as changes in the market environment and exchange rate fluctuations.
Jiangxi Synergy Pharmaceutical Co LtdPassed Australian TGA GMP certification, enabling market access.