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112! Shijiazhuang Sihua Pharmaceutical Group’s Two Specifications of Acetaminophen Tablets Have Passed Evaluation

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Honors Announcement

发布时间：2024-12-28

【概要描述】 On February 27, the supplemental application for acetaminophen tablets (0.3 g and 0.5 g) submitted by Shijiazhuang Sihua Pharmaceutical Group was approved by the National Medical Products Administration, thereby passing the evaluation of quality and therapeutic equivalence for generic drugs. To date, the Group has had a total of 112 drug varieties comprising 148 dosage forms that have either passed or are deemed to have passed this equivalence assessment.

112! Shijiazhuang Sihua Pharmaceutical Group’s Two Specifications of Acetaminophen Tablets Have Passed Evaluation

On December 27, the supplemental application for acetaminophen tablets (0.3 g and 0.5 g) submitted by Shijiazhuang Sihua Pharmaceutical Group was approved by the National Medical Products Administration, thereby passing the evaluation of generic drug quality and therapeutic equivalence. To date, the Group has had a total of 112 product varieties comprising 148 specifications that have either passed or are deemed to have passed the consistency evaluation.

Previously, the Group’s application for Acetaminophen Mannitol Injection (50 mL: 500 mg) was approved in May 2024 as the second domestically approved product and was either approved or deemed to have passed the consistency evaluation.

According to available information, acetaminophen tablets are an over-the-counter antipyretic and analgesic medication indicated for the treatment of fever associated with the common cold or influenza, as well as for the relief of mild to moderate pain, including headache, joint pain, migraine, toothache, muscle pain, neuralgia, and dysmenorrhea.

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