Humanwell Healthcare’s midazolam injection approved in Germany

Humanwell Healthcare Group announced that its controlling subsidiary, Yichang Humanwell Pharmaceutical Co., Ltd., has received marketing authorization from the German Federal Institute for Drugs and Medical Devices (BfArM) for its midazolam injection. The approval, granted in June 2025, follows an earlier French AN SM approval and is valid for five years. The drug is approved for various indications, including conscious sedation, pre-anesthetic medication, anesthesia induction, and sedation in ICU patients.

The midazolam injection will be available in 1mg/ml (5mL) and 5mg/ml (1mL, 3mL, 10mL) formulations. The total investment for registering this project in both France and Germany is approximately 1,000 yuan. According to IQVIA data, the German market for midazolam injection was valued at approximately $7m in 2024, with key manufacturers including Teva, Hameln, and Ethypharm.

This approval allows Yichang Humanwell Pharmaceutical to sell the product in Germany, significantly boosting the company’s international business expansion. Investors are cautioned to consider the potential impact of local policies, market conditions, and exchange rate fluctuations on actual sales performance.