Xinhua Pharmaceutical Obtains NMPA Approval for Magnesium-, Sodium- and Potassium-Based Bowel-Cleansing Solution

Bulletin Express
Sep 18

Shandong Xinhua Pharmaceutical Company Limited (Xinhua Pharmaceutical) announced that it has secured a Drug Registration Certificate from China’s National Medical Products Administration (NMPA) for its Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution.

The prescription-only product, registered as a Class 4 chemical drug under approval number H20266008, is formulated as a 176 ml oral solution containing 3.276 g magnesium sulfate (as MgSO₄·7H₂O), 17.510 g sodium sulfate and 3.130 g potassium sulfate. It is indicated for adult bowel cleansing prior to procedures requiring intestinal visualization, including endoscopy, radiological examinations and surgery.

The product is included in China’s 2025 National Drug Catalogue for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance as a Category B medicine. Market data cited in the announcement show that sales of comparable magnesium-, sodium- and potassium-based bowel-cleansing solutions in China’s public medical institutions reached approximately RMB 490.00 million in 2025.

Management stated that the approval broadens Xinhua Pharmaceutical’s digestive system drug portfolio and strengthens the company’s competitive position. The company cautioned, however, that pharmaceutical sales remain subject to domestic policy changes, tendering dynamics and market conditions.

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