SSY Group Limited has announced that it has received approval from the National Medical Products Administration (NMPA) of China for the production and registration of Compound Sodium Acetate and Glucose Injection (500ml and 200ml). The drug is classified as a type 3 chemical drug and has passed the consistency evaluation, positioning SSY Group as one of the first three manufacturers in China to receive this approval.
Clinical Use and Significance
Compound Sodium Acetate and Glucose Injection is indicated for replenishing and maintaining water and electrolytes, as well as supplying energy when oral administration is not possible or sufficient. It represents the latest generation of sugar-containing sodium acetate balanced crystalloid solutions. This approval provides healthcare professionals with an additional tool for managing patients who require intravenous hydration and electrolyte support.
Regulatory Context
The approval signifies that SSY Group's product meets the stringent quality and efficacy standards set by the NMPA. The consistency evaluation process ensures that generic drugs perform comparably to their branded counterparts, promoting patient safety and therapeutic effectiveness.
Company Statement
According to the company, this announcement is a voluntary disclosure to keep shareholders and potential investors informed about the latest business developments within the Group. The approval is expected to positively impact SSY Group's market presence and contribute to its growth in the pharmaceutical sector.
