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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 Abounds! Shijiazhuang Sihua Pharmaceutical Group’s Bisoprolol Amlodipine Tablets and Entacapone Tablets Have Been Approved
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发布时间：2024-06-04
【概要描述】
In early summer, Shijiazhuang Sihua Pharmaceutical Group is reaping a bountiful harvest in research and innovation. Following the simultaneous approval on May 30 of three new products—active pharmaceutical ingredients and finished dosage forms—the group’s Class 4 chemical drugs, bisoprolol amlodipine tablets (5 mg) and entacapone tablets (0.2 g), have now obtained drug production registration approvals from the National Medical Products Administration, which also deem them to have passed the consistency evaluation. Notably, the bisoprolol amlodipine tablets (5 mg) represent the second domestic approval for this product, while the entacapone tablets (0.2 g) mark the third.
In early summer, Shijiazhuang Sihua Pharmaceutical Group is reaping a bountiful harvest in research and development innovation. Following the simultaneous approval on May 30 of three new products—active pharmaceutical ingredients and finished dosage forms—the group’s Class 4 chemical drugs, bisoprolol amlodipine tablets (5 mg) and entacapone tablets (0.2 g), have now obtained drug production registration approvals from the National Medical Products Administration, which also deem them to have passed the consistency evaluation. Notably, the bisoprolol amlodipine tablets (5 mg) represent the second domestic approval for this product, while the entacapone tablets (0.2 g) mark the third.
According to reports, bisoprolol amlodipine tablets are a fixed-combination formulation comprising bisoprolol fumarate (a β-blocker) and amlodipine besylate (a calcium channel blocker), which can be used as an alternative therapeutic option for the treatment of hypertension in patients who are currently taking individual monotherapies at equivalent doses to those in the combination product and whose blood pressure is well controlled. Data from MeneNet show that in 2023, sales of this product in public hospitals in key provinces and cities grew by approximately 846%, reflecting rapid volume expansion.
Entacapone tablets are an anti-Parkinsonian medication; they are a highly effective, selective, and reversible peripheral catechol-O-methyltransferase (COMT) inhibitor. This product can be used as an adjunct to standard therapies such as levodopa/benserazide or levodopa/carbidopa for the treatment of Parkinson’s disease that is not adequately controlled by these medications, as well as for managing the “end-of-dose” phenomenon (motor fluctuations). According to data published by MeneNet, in 2022 among the top 10 anti-Parkinsonian drugs sold at physical retail pharmacies in Chinese cities, the top five were benserazide hydrochloride tablets, pramipexole hydrochloride tablets, rasagiline mesylate tablets, entacapone tablets, and piribedil sustained-release tablets.
In recent years, Shijiazhuang Sihua Pharmaceutical Group has focused on developing market-driven products for the treatment of age-related diseases in areas such as cardiovascular and neurological disorders, with the aim of meeting clinical needs and improving public health. The company has continuously expanded its product pipeline and strengthened its product portfolio, resulting in a robust lineup of antihypertensive drugs—including nifedipine sustained-release tablets (II), felodipine sustained-release tablets, valsartan/amlodipine tablets (I), and urapidil hydrochloride injection—as well as a range of anti-Parkinson’s medications, such as rasagiline mesylate tablets and entacapone tablets. This has established a positive cycle of product iteration and upgrading, significantly advancing the company’s innovative, high-quality development to a new level.
To date, Shijiazhuang Sihua Pharmaceutical Group has obtained approval for 39 new products, and a total of 87 drug varieties comprising 118 dosage forms have either passed or been deemed to have passed the consistency evaluation.
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