Xinhua Pharmaceutical secures approval for lidocaine prilocaine cream

Shandong Xinhua Pharmaceutical Co., Ltd. announced on November 25, 2025, it has received a drug registration certificate for lidocaine prilocaine cream from the National Medical Products Administration. The cream, registered as a Category 4 chemical drug, is a compound preparation indicated for topical anesthesia of the skin in various procedures such as needle punctures, minor superficial surgery, and wound debridement. The approved specification is 30g, containing 750mg of lidocaine and 750mg of prilocaine.

The application for market authorization for domestic production was submitted in February 2024 and approved in November 2025. This approval allows the company to produce and sell the drug.

According to statistical data, sales of lidocaine prilocaine cream in public medical institutions in China reached approximately 6.15 billion yuan in 2024. The company expects this approval to help penetrate new market segments and bolster its overall competitiveness, though it cautions investors about potential market volatility due to pharmaceutical industry policies and competitive factors.