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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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INNOVATIONSSY Group Limited has built a relatively perfect scientific research and innovation system with the development mode of “production, learning, research, and application” of multi-disciplinary integration and multi-directional combination.
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RECRUITIt has established high-level innovation platforms such as engineering laboratory and technology research center jointly with Chinese Academy of Sciences, and now has nearly 400 high-level talents in drug research, analysis and clinical research.
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SUBSIDIARIESThe company has a diversified business development pattern of R&D, production and export of new drugs, generic drugs, characteristic APIs, advanced finished pharmaceutical products, biological preparations and pharmaceutical packaging materials.
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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’s two new products—cycloserine capsules and lornoxicam for injection—were approved on the same day.
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发布时间：2024-10-23
【概要描述】
On October 21, Shijiazhuang Sihua Pharmaceutical Group’s applications for Category 3 chemical drug cycloserine capsules and Category 4 chemical drug lornoxicam for injection both received drug production registration approvals from the National Medical Products Administration on the same day, and are deemed to have passed the consistency evaluation.
On October 21, Shijiazhuang Sihua Pharmaceutical Group’s applications for Category 3 chemical drug cycloserine capsules and Category 4 chemical drug lornoxicam for injection both received drug production registration approvals from the National Medical Products Administration on the same day, and are deemed to have passed the consistency evaluation.
According to available information, cycloserine capsules are primarily indicated for the treatment of active pulmonary and extrapulmonary tuberculosis caused by mycobacteria susceptible to this drug and inadequately responsive to first-line anti-tuberculosis therapy; they may also be used for the treatment of acute urinary tract infections caused by susceptible Gram-positive and Gram-negative bacteria. Lornoxicam for injection is mainly indicated for the short-term management of acute mild to moderate pain in adults who are not suitable for oral administration.
Cycloserine capsules were developed by Eli Lilly and Company in the United States and launched in the U.S. in 1982. The successful approval of the cycloserine capsules developed by the Group further expands the company’s pipeline of oral antibacterial formulations, and upon launch will provide tuberculosis patients with more treatment options.
To date, the Group has had 106 drug varieties comprising 139 dosage forms and specifications that have either passed or are deemed to have passed the evaluation of generic drug quality and therapeutic equivalence.
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