Zhongsheng Pharma wins approval for ambroxol hydrochloride oral solution

Guangdong Zhongsheng Pharmaceutical Co., Ltd. recently announced it received drug registration certificates from the National Medical Products Administration for its ambroxol hydrochloride oral solution. The newly approved solution comes in two specifications: 10ml: 30mg and 100ml: 0.3g, falling under chemical drug category 4. This approval enables the company to market a mucolytic agent for conditions involving viscous sputum and difficult expectoration due to acute and chronic bronchitis.

The ambroxol hydrochloride oral solution, a Class B drug under medical insurance, adds to Zhongsheng Pharma's respiratory product line. The company states this product has passed the consistency evaluation for chemical generic drugs, similar to its other respiratory medications. This strengthens its competitive position in the respiratory treatment market.

Sales data from the Minai network database indicates total sales of ambroxol hydrochloride oral solution in public hospitals and urban physical pharmacies in China were RMB 71,084 million in 2022, RMB 81,766 million in 2023, and RMB 84,953 million in 2024. The company expects this approval to positively impact its future performance, though it notes sales may be influenced by national policies and market conditions.