Two New Products—Pentoxifylline Sustained-Release Tablets and Sorbitol-Mannitol Irrigation Solution—Approved for Shijiazhuang Sihua Pharmaceutical Group


发布时间:2023-03-23

【概要描述】 On March 22, Shijiazhuang Sihua Pharmaceutical Group received drug production registration approvals from the National Medical Products Administration for two new products: a Class 3 chemical drug—pentoxifylline sustained-release tablets (0.4 g)—and a sorbitol-mannitol irrigation solution (3,000 ml). These approvals also confer deemed approval under the consistency evaluation framework. To date this year, the Group has secured registration for a total of 13 new products.
On March 22, Shijiazhuang Sihua Pharmaceutical Group received drug production registration approvals from the National Medical Products Administration for two new products: a Class 3 chemical drug—pentoxifylline sustained-release tablets (0.4 g)—and a sorbitol-mannitol irrigation solution (3,000 ml). These approvals also confer deeming status as having passed the consistency evaluation. To date this year, the Group has secured approval for a total of 13 new products.
Theophylline is primarily used for cerebral and peripheral circulatory disorders; sorbitol-mannitol irrigation solutions are mainly employed for intraoperative irrigation during transurethral resection of the prostate and other urological procedures.
A responsible official from the Group’s R&D Center stated that the approval of these two new products brings the total number of products that have either passed or are deemed to have passed the consistency evaluation to 40 varieties encompassing 52 specifications, which will positively contribute to further expanding the product portfolio of pentoxifylline and flushing agents.

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