We are pleased to announce that Jiudian Hongyang's active pharmaceutical ingredient (API) Docusate Sodium (Y20230000318) has successfully passed the review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) and has been officially approved with an "A" status.

Docusate Sodium, chemically known as sodium 1,4-bis(2-ethylhexyl) sulfosuccinate, typically appears as a colorless or pale yellow liquid. It exhibits excellent wetting and detergent properties, with solubility in water as well as organic solvents such as benzene and carbon tetrachloride. In the pharmaceutical field, it is primarily used for the treatment of chronic constipation as a non-irritating laxative. Upon oral administration, it facilitates the penetration of water and lipids into stool, thereby softening fecal matter. The drug is mainly excreted via bile, providing relief for patients suffering from difficult bowel movements.

  Additionally, Docusate Sodium is widely used as an ionic surfactant in pharmaceutical excipients, offering superior solubilizing, wetting, dispersing, and emulsifying properties. It is low in toxicity and maintains stable compatibility with various drugs. It is primarily employed in capsule formulations and direct compression tablets to enhance wetting and dissolution. Its wetting properties accelerate the penetration of dissolution media into granules and ensure uniform distribution of poorly wettable APIs in excipient mixtures (e.g., valsartan tablets, candesartan cilexetil tablets).

The application prospects of Docusate Sodium in the pharmaceutical industry are vast. Beyond serving as an active ingredient for chronic constipation treatment, it is also widely utilized in excipient formulations. Market data shows that Docusate Sodium-based formulations generated over 100 million yuan in domestic sales in 2023. With growing public awareness of health and increasing demand for medications addressing common conditions like constipation, Docusate Sodium is poised to capture a larger market share due to its mild yet effective properties. Meanwhile, researchers continue to explore its broader medicinal value and potential applications, which may play a significant role in the treatment and prevention of more diseases in the future.

As a highly regarded API in the pharmaceutical sector, the successful approval of Jiudian Hongyang's Docusate Sodium further strengthens the company's competitiveness in the raw and auxiliary materials market. It will also provide downstream formulation manufacturers with safer, compliant, and high-quality raw materials, injecting new vitality into the pharmaceutical industry. This advancement further promotes the accessibility and internationalization of domestically produced medicines.