Good News! Shijiazhuang Sihua Pharmaceutical Group’s Terazosin Phosphate Tablets Have Been Approved
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发布时间:2023-12-04
【概要描述】
On December 1, Shijiazhuang Sihua Pharmaceutical Group received production registration approval from the National Medical Products Administration for its newly developed Class 4 chemical drug—Terdazolam Phosphate Tablets (200 mg)—which is deemed to have passed the bioequivalence evaluation, thereby presenting a special gift to commemorate the group’s 75th anniversary.
On December 1, Shijiazhuang Sihua Pharmaceutical Group received production registration approval from the National Medical Products Administration for its Class 4 new chemical drug—Terdazolam Phosphate Tablets (200 mg)—which is deemed to have passed the bioequivalence evaluation, presenting a special gift to commemorate the group’s 75th anniversary.
Trazodone phosphate tablets are primarily indicated for the treatment of acute bacterial skin and skin-structure infections (ABSSSI) caused by susceptible isolates of Gram-positive bacteria, including Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactiae, the Streptococcus anginosus group, and Enterococcus faecalis.
In recent years, Shijiazhuang Sihua Pharmaceutical Group has focused on building an integrated development advantage spanning both active pharmaceutical ingredients and finished dosage forms. Previously, in April 2023, the group’s newly developed tazobactam phosphate API was approved by the National Medical Products Administration and registered as an API intended for use in marketed formulations.
To date, the Group has achieved consistency evaluation—or is deemed to have achieved it—for a total of 67 drug varieties encompassing 87 dosage forms and strengths, placing it at the forefront of the industry in generic drug consistency evaluation.
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