Shandong Xinhua Pharmaceutical Wins NMPA Approval for New Ambroxol–Clenbuterol Oral Solution

Shandong Xinhua Pharmaceutical Company Limited Class H ( (HK:0719) ) has provided an announcement.

Shandong Xinhua Pharmaceutical Company Limited announced that it has obtained a National Medical Products Administration drug registration certificate for its Ambroxol Hydrochloride and Clenbuterol Hydrochloride oral solution, a Class 3 chemical prescription medicine for domestic production. The approval, following a review confirming compliance with China’s Pharmaceutical Administration Law and quality standards, enables the company to move toward production and sale of the product, potentially expanding its respiratory treatment portfolio and strengthening its position in the Chinese prescription drug market, subject to meeting pharmaceutical production quality management requirements.

Xinhua Pharmaceutical submitted the marketing application for this oral solution to the Center for Drug Evaluation in May 2024, and the materials were formally accepted before the certificate was granted in May 2026. The regulatory clearance marks the completion of a roughly two-year review process and signals that the company can now finalize quality standards, product instructions, labels and production processes needed to commercialize the new drug in China’s regulated market.

More about Shandong Xinhua Pharmaceutical Company Limited Class H

Shandong Xinhua Pharmaceutical Company Limited is a Mainland China–based drug manufacturer listed in Hong Kong, operating in the pharmaceutical industry. The company focuses on the development, production and sale of prescription medicines and chemical pharmaceuticals for the domestic market, supported by a board comprising executive, non-executive and independent non-executive directors.

Average Trading Volume: 720,442

Technical Sentiment Signal: Hold

Current Market Cap: HK$9.52B

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