SSY Group secures multiple drug production, registration approvals in China

SSY Group Limited has received approvals for drug production and registration for Urapidil Sustained-release Capsules (30mg) and Nicardipine Hydrochloride and Sodium Chloride Injection (200ml) from China's National Medical Products Administration (NMPA). Both are classified as type 3 chemical drugs, passed consistency evaluations, and mark the first such approvals for PRC entities. Urapidil treats various forms of hypertension and benign prostatic hyperplasia, while Nicardipine is used for emergency hypertension during surgery and hypertensive crises. The company previously obtained NMPA registration approvals for the bulk drugs of both products in May 2023 and March 2025, respectively.

In addition, SSY Group secured NMPA approval for the production and registration of Drotaverine Hydrochloride Injection (2ml), a type 4 chemical drug that also passed consistency evaluation. This injection is primarily used to treat smooth muscle spasms related to biliary tract and urinary system diseases, and as an adjuvant therapy for gastrointestinal spasms and dysmenorrhea. The bulk drug for Drotaverine Hydrochloride was approved for NMPA registration in August 2025.

These approvals are part of SSY Group's ongoing product development, enhancing its portfolio of pharmaceutical offerings in the Chinese market.