Xinhua Pharmaceutical obtains NMPA approval for Ambroxol-Clenbuterol oral solution

Bulletin Express05-11

Shandong Xinhua Pharmaceutical Company Limited announced that its Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution has received a Drug Registration Certificate from China’s National Medical Products Administration (NMPA).

The approved product is a Class 3 chemical prescription drug in oral-solution form, specified at 100 ml containing 150 mg of ambroxol hydrochloride and 100 μg of clenbuterol hydrochloride. The drug targets acute and chronic respiratory diseases associated with cough, viscous sputum, difficult sputum excretion and wheezing, including acute and chronic bronchitis and emphysema.

Regulatory milestones show the application was submitted to the Center for Drug Evaluation in May 2024 and approval was granted in May 2026 under certificate number 2026S01462 and drug approval number H20264248.

Market data cited in the announcement indicate that sales of comparable Ambroxol-Clenbuterol oral solutions in China’s public medical institutions reached approximately RMB 740.00 million in 2024. Management expects the new approval to expand the company’s respiratory portfolio and strengthen overall competitiveness.

The company cautions that pharmaceutical sales remain sensitive to domestic policy changes, bidding processes and market dynamics, and advises investors to consider related uncertainties.

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