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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
Good News! Shijiazhuang No.4 Pharmaceutical has obtained the National Medical Products Administration’s drug production registration approval for its newly developed linezolid glucose injection (100 ml).
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发布时间：2021-07-03
【概要描述】
The linezolid glucose injection (100 mL) developed and submitted for approval by Shijiazhuang Sihua Pharmaceutical Co., Ltd. has obtained the Drug Production Registration Approval from the National Medical Products Administration, which is deemed to have passed the consistency evaluation.
On July 1, Shisi Pharmaceutical Group (02005.HK) issued an announcement stating that Linezolid Glucose Injection (100 ml), developed and submitted for approval by its wholly owned subsidiary Shijiazhuang Sihua Pharmaceutical Co., Ltd., has now received drug production registration approval from the National Medical Products Administration, which is deemed to have passed the consistency evaluation. This follows the company’s recent approval of supplemental applications for Azithromycin for Injection (0.5 g and 0.25 g) within the past week, marking another new product launch approval for the company.
In April 2020, Shijiazhuang Sihua Pharmaceutical’s marketing application for linezolid glucose injection, submitted as a Class 4 generic drug, was accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. After a review period of 15 months, the product was granted manufacturing registration approval and was deemed to have passed the consistency evaluation.
According to available information, linezolid is a synthetic oxazolidinone antibiotic primarily used to treat infections caused by Gram-positive bacteria that are resistant to other antibiotics. In the Chinese market, linezolid is marketed in the forms of linezolid tablets, linezolid dry suspension, and linezolid glucose injection. Data from MeneNet show that in recent years, sales of linezolid at the end-user level—namely, urban public hospitals, county-level public hospitals, urban community health centers, and township health clinics (collectively referred to as China’s public medical institutions)—have increased year after year. In 2018, total sales revenue reached RMB 1.932 billion, representing a year-on-year increase of 25.64%, with linezolid glucose injection accounting for 78.41% of the market share.
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