SSY Group secures NMPA approval for seven new drugs

SSY Group Limited has received drug production and registration approvals from the National Medical Products Administration of China (NMPA) for a total of seven new drugs. These approvals include Perindopril Arginine Tablets (10mg), a type 4 chemical drug for hypertension and congestive heart failure, and Progesterone Injection (II) (1.112ml: 25mg), a type 3 chemical drug for assisted reproductive technology. Both are regarded as having passed consistency evaluation, with Perindopril Arginine being the second such approval for PRC entities.

Further approvals cover Labetalol Hydrochloride Injection (20ml: 100mg) for various types of hypertension, Calcium Chloride Injection (10ml: 1g) for acute hypocalcemia, and Multiple Electrolytes and Sodium Acetate Injection (500ml) for isotonic dehydration, all classified as type 3 chemical drugs that passed consistency evaluation. Multiple Electrolytes Injection (V) (500ml), also a type 3 chemical drug, was approved for water and electrolyte supplementation.

Notably, Levosalbutamol Hydrochloride Nebuliser Solution (3ml: 0.63mg), a type 3 chemical drug, received approval for bronchospasm treatment. This follows the group's earlier announcement on 4 September 2023, regarding the NMPA's approval for its Levosalbutamol Hydrochloride bulk drug to become a bulk drug for market preparations.