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Tonghe Pharmaceutical (300636.SZ): Mirabelone and Empagliflozin obtained Australian drug GMP compliance certificates

智通財經·08/04/2026 08:57:03
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Zhitong Finance App News, Tonghe Pharmaceutical (300636.SZ) issued an announcement. The company recently received the GMP compliance certificate for mirabelone and englicin drugs issued by the Australian Drug Administration (TGA). Mirabeiron is a selective beta3-adrenal receptor agonist. It can improve bladder filling and urinary storage capacity by activating beta3-adrenal receptors on the urinary bladder. It is clinically used to treat excessive bladder activity with symptoms such as urgent incontinence, urgency to urinate, and frequent urination. Empagliflozin is suitable for the treatment of type 2 diabetes.

The company has passed TGA's GMP certification for the first time, indicating that the company has been recognized by TGA in terms of quality systems and production environment facilities. Australia is a member country of the International Drug Certification Cooperation Organization (PIC/S). This certification helps the company to continue to promote international market development.