Kudos! In the first month of the new year, five new product approvals were secured—Shijiazhuang Sihua Pharmaceutical Group’s Terbutaline Sulfate Injection has been approved.


发布时间:2023-01-30

【概要描述】 Immediately after the Spring Festival, Shijiazhuang Sihua Pharmaceutical Group announced another significant breakthrough in R&D and innovation: on January 29, the group’s newly developed and submitted terbutaline sulfate injection (1 ml: 0.5 mg) received drug production registration approval from the National Medical Products Administration, making it the third such product approved in China and deemed to have passed the consistency evaluation. This marks the fifth new-product production approval the company has secured in the first month of this year.
Immediately after the Spring Festival, Shijiazhuang Sihua Pharmaceutical Group once again announced encouraging news in R&D and innovation: on January 29, the group’s newly developed and submitted terbutaline sulfate injection (1 ml: 0.5 mg) received drug production registration approval from the National Medical Products Administration, making it the third such product approved in China and deeming it to have passed the consistency evaluation. This marks the fifth new-product production approval the group has secured in the first month of this year.
According to available information, terbutaline sulfate injection is classified as a Class 3 new chemical drug and is primarily indicated for the prevention and relief of bronchial asthma and reversible bronchospasm associated with bronchitis and emphysema.
Previously, in 2021, Shijiazhuang Sihua Pharmaceutical Co., Ltd. obtained approval from the National Medical Products Administration for the registration of its Class 4 chemical drug—terbutaline sulfate solution for nebulization (2 ml: 5 mg)—making it the second domestic manufacturer to receive such approval, which is deemed equivalent to passing the bioequivalence evaluation. In the same year, Hebei Guolong Pharmaceutical Co., Ltd., a subsidiary of the group, also secured manufacturing approval for its terbutaline sulfate active pharmaceutical ingredient.
In recent years, Shijiazhuang Sihua Pharmaceutical Group has consistently pursued a “API-plus-formulation” development strategy, leveraging innovation to strengthen, extend, and complete the industrial chain. This approach has effectively facilitated the deep integration of the innovation chain, supply chain, industrial chain, and value chain, resulting in a steady accumulation of product innovations that have gradually evolved into comprehensive product lines. Consequently, the company’s market competitiveness has continuously improved, and its ranking among the Top 100 Pharmaceutical Manufacturers in China has been steadily advancing.

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