Shijiazhuang Sihua Pharmaceutical Group’s Cefalexin Capsules Have Passed Evaluation, and Its Doxazosin Mesylate API Was Approved on the Same Day


发布时间:2024-04-08

【概要描述】 Spring tides are surging, and good news is coming one after another. On April 8, the cefalexin capsules (0.25 g and 0.125 g) submitted by Shijiazhuang Sihua Pharmaceutical Group were approved by the National Medical Products Administration, having passed the evaluation of quality and therapeutic equivalence for generic drugs. In addition, doxazosin mesylate, submitted by the Group’s Hebei Guolong Pharmaceutical Co., Ltd., was also approved on the same day and registered as an active pharmaceutical ingredient for use in marketed dosage forms.
Spring tides are surging, and good news keeps pouring in. On April 8, the cefalexin capsules (0.25 g and 0.125 g) submitted by Shijiazhuang Sihua Pharmaceutical Group were approved by the National Medical Products Administration, having passed the evaluation of quality and therapeutic equivalence for generic drugs. In addition, doxazosin mesylate, submitted by the Group’s Hebei Guolong Pharmaceutical Co., Ltd., was also approved on the same day and registered as an active pharmaceutical ingredient for use in marketed dosage forms.
According to available information, cefalexin capsules are primarily indicated for the treatment of respiratory tract infections caused by susceptible bacteria, including acute tonsillitis, pharyngitis, sinusitis, bronchitis, and pneumonia, as well as otitis media, urinary tract infections, and skin and soft-tissue infections. Doxazosin mesylate, as an antihypertensive agent, is mainly used in patients with primary mild to moderate hypertension and in hypertensive patients with benign prostatic hyperplasia.
In recent years, Shijiazhuang Sihua Pharmaceutical Group has been driven by innovation and aligned with national development strategies and market demands, striving to build an integrated “active pharmaceutical ingredient plus finished dosage form” development advantage. The company has steadily accumulated research and innovation achievements, with the number of applications submitted and approvals obtained repeatedly reaching new highs. To date, a total of 79 drug varieties comprising 108 specifications have either passed or are deemed to have passed the bioequivalence evaluation for generic drugs.
The head of the group’s R&D center stated that the next step will be to fully leverage the enterprise’s pivotal role in scientific and technological innovation, continuously advance high-level self-reliance and strength in science and technology, focus on the cutting edge of industrial development, constantly optimize the structure and layout of the innovation chain, enhance original innovation capabilities, and develop and produce more “Chinese medicines” tailored to the genetic heritage and physical characteristics of the Chinese population, thereby better serving the health needs of the people.

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