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ABOUT USSSY Group Limited is a large high-tech pharmaceutical enterprise with coordinated development of R&D and industrialization in multiple fields such as new drugs, generic drugs, characteristic APIs
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CONTACTWe will continue to strengthen innovation-driven development, will vigorously encourage the integration of production and research, strengthen and improve the five domains: new drugs, biological drugs, traditional Chinese medicine, generic drugs and APIs
Shijiazhuang Sihua Pharmaceutical Group Receives Approval for Four New Products in Three Days
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发布时间：2023-03-24
【概要描述】
Ten miles of spring breeze carry good news, and now is the perfect time for a thousand sails to set out in competition. On March 24, the sodium lactate Ringer’s injection (500 ml) submitted by Shijiazhuang Sihua Pharmaceutical Group passed the National Medical Products Administration’s evaluation of generic drug quality and therapeutic equivalence, making the group the second domestic enterprise to obtain such approval for this product. This marks the fourth consistency-evaluated product approved for the group in the past three days.
“Ten miles of spring breeze carry good news; with a thousand sails racing forward, the time is right.” On March 24, the sodium lactate Ringer’s injection (500 ml) submitted by Shijiazhuang Sihua Pharmaceutical Group passed the National Medical Products Administration’s evaluation of generic drug quality and therapeutic equivalence, making the group the second domestic enterprise to achieve such certification for this product. This marks the fourth product from the group to receive approval under the consistency evaluation program in the past three days.
On March 22, Shijiazhuang Sihua Pharmaceutical Group obtained production approval for Category 3 chemical drug sustained-release theophylline tablets (0.4 g) and sorbitol-mannitol irrigation solution (3,000 ml), which are deemed to have passed the consistency evaluation.
One day later, on March 23, the Group’s achievements in pharmaceutical consistency evaluation continued to expand, as it obtained the National Medical Products Administration’s approval for manufacturing registration of Azithromycin for Injection (0.5 g) following a consistency assessment. Azithromycin for Injection is primarily indicated for the treatment of infections caused by susceptible bacteria, such as community-acquired pneumonia and pelvic inflammatory disease. To date, Shijiazhuang Sihua Pharmaceutical Group has developed multiple dosage forms of azithromycin, including the active pharmaceutical ingredient, dispersible tablets, dry suspension, conventional tablets, glucose injection, and lyophilized powder for injection, thereby progressively enriching its “API-plus-formulation” product portfolio. This expansion creates greater capacity to meet diversified market demands and further capitalize on the Group’s competitive advantages.
Following the approval of Sodium Lactate Ringer’s Injection (500 mL) in the consistency evaluation, the Group now has a total of 42 drug varieties comprising 54 dosage forms that have either passed or are deemed to have passed the consistency evaluation.
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