Good News! Shijiazhuang Sihua Pharmaceutical Group’s two new product specifications—terbutaline sulfate solution for nebulization and peritoneal dialysis solution—have consecutively passed the evaluation.


发布时间:2023-04-13

【概要描述】 In the blossoming month of April, every moment is precious as innovative achievements “bloom in competition.” Over the past two days, Shijiazhuang No. 4 Pharmaceutical Group has reaped a series of significant research and development successes: on April 12, the group’s application for Terbutaline Sulfate Nebulization Inhalation Solution (1 ml: 2.5 mg) received production registration approval from the National Medical Products Administration, making this dosage form only the second in China to be deemed to have passed the consistency evaluation; on April 13, Peritoneal Dialysis Solution (Lactate–G 2.5%) became the first in China to pass the consistency evaluation, injecting new momentum into the development of the peritoneal dialysis solution market.
In the fragrant month of April, every moment is precious as innovative achievements bloom in full glory. Over the past two days, Shijiazhuang Sihua Pharmaceutical Group has reaped a series of significant research and development successes: on April 12, the group’s application for Terbutaline Sulfate Nebulization Inhalation Solution (1 ml: 2.5 mg) was approved by the National Medical Products Administration for manufacturing registration, making this dosage form only the second in China to be deemed to have passed the consistency evaluation; on April 13, Peritoneal Dialysis Solution (Lactate–G 2.5%) became the first in China to pass the consistency evaluation, injecting new momentum into the development of the peritoneal dialysis solution market.
According to reports, Shijiazhuang Sihua Pharmaceutical Group has previously obtained manufacturing approval from the National Medical Products Administration for terbutaline sulfate solution for nebulization (2 ml: 5 mg), terbutaline sulfate API, and terbutaline sulfate injection (1 ml: 0.5 mg). The recent approval of the 1 ml: 2.5 mg formulation of terbutaline sulfate solution for nebulization signifies that the Group’s product portfolio for this drug is becoming increasingly comprehensive, thereby creating greater opportunities to meet diversified market demands and further capitalize on its competitive advantages.
This peritoneal dialysis solution (lactate-based, 2.5%) has become the first in China to pass the consistency evaluation, following the group’s earlier achievement in June 2022 when its lactate-based peritoneal dialysis solution (1.5%) was the first in China to receive such approval. It is understood that, as the group continues to expand the scope of its consistency-evaluation achievements for this product category, it will further strengthen and extend the peritoneal dialysis product portfolio, thereby providing clinicians with a broader range of higher-quality options for peritoneal dialysis therapy.
In recent years, Shijiazhuang Sihua Pharmaceutical Group has taken innovation as its guiding principle, continuously increasing its R&D investment and steadfastly advancing the development and research of innovative drugs, generic drugs, specialty APIs, and products undergoing bioequivalence evaluation. To date, the group has achieved bioequivalence or deemed-to-be-bioequivalent status for a total of 44 drug varieties encompassing 57 dosage forms, thereby significantly boosting the company’s ascent up the value chain toward the mid- to high-end segments.
 

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