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Shijiazhuang Sihua Pharmaceutical Group’s Tranexamic Acid Tablets (0.25 g) Have Been Approved

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Honors Announcement

发布时间：2026-04-03

【概要描述】 On April 3, Shijiazhuang Sihua Pharmaceutical Group’s Class 4 chemical drug—tranexamic acid tablets (0.25 g)—received production registration approval from the National Medical Products Administration and is deemed to have passed the bioequivalence evaluation. This marks the group’s 10th newly approved dosage-form product so far this year. To date, the group has a total of 173 drug varieties comprising 226 specifications that have either passed or are deemed to have passed the bioequivalence evaluation for generic drugs in terms of quality and therapeutic efficacy.

Shijiazhuang Sihua Pharmaceutical Group’s Tranexamic Acid Tablets (0.25 g) Have Been Approved

On April 3, Shijiazhuang Sihua Pharmaceutical Group’s Class 4 chemical drug—tranexamic acid tablets (0.25 g)—received manufacturing registration approval from the National Medical Products Administration and is deemed to have passed the bioequivalence evaluation. This marks the group’s 10th newly approved dosage-form product so far this year. To date, the group has a total of 173 drug varieties comprising 226 specifications that have either passed or are deemed to have passed the bioequivalence evaluation for generic drugs in terms of quality and therapeutic efficacy.

According to available information, tranexamic acid tablets are an antifibrinolytic agent primarily used to treat various types of bleeding caused by acute or chronic, localized or systemic primary hyperfibrinolysis.

In recent years, the Group has aligned itself with evolving pharmaceutical market demands, anchored its R&D strategy in industry trends and clinical needs, and adopted a core R&D approach characterized by “combining generic and innovative development, highlighting distinctive strengths, and focusing on key priorities.” On this basis, the Group has systematically advanced its strategic positioning and development in the oral dosage-form segment, actively building a product portfolio that is both competitively positioned in the market and forward-looking in terms of future growth.

Previously, the Group’s tranexamic acid tablets (0.5 g) and tranexamic acid sodium chloride injection were successively approved. The recent approval of a new 0.25-g strength of tranexamic acid tablets will further expand the product portfolio for this indication, creating favorable conditions for better meeting diversified market needs. At the same time, the increasingly comprehensive product matrix and the ongoing optimization of the product mix provide strong support for the company’s accelerated transformation and development.

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