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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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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 New Product Rasagiline Mesylate Tablets Approved
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发布时间：2024-05-21
【概要描述】
On May 21, Shijiazhuang Sihua Pharmaceutical Group’s Class 4 chemical drug, Rasagiline Mesylate Tablets (1 mg), received manufacturing registration approval from the National Medical Products Administration and is deemed to have passed the bioequivalence evaluation.
On May 21, Shijiazhuang Sihua Pharmaceutical Group’s Class 4 chemical drug, Rasagiline Mesylate Tablets (1 mg), received production registration approval from the National Medical Products Administration and is deemed to have passed the bioequivalence evaluation.
Rasagiline mesylate tablets are a selective, second-generation, irreversible monoamine oxidase B (MAO-B) inhibitor, primarily indicated for monotherapy in patients with primary Parkinson’s disease and for combination therapy with levodopa in patients experiencing end-of-dose fluctuations.
In January of this year, the rasagiline mesylate active pharmaceutical ingredient developed by the Group was approved for registration as an API used in marketed dosage forms. The recent approval of rasagiline mesylate tablets (1 mg) represents another significant achievement in the Group’s vigorous implementation of integrated API–formulation development.
To date this year, the Group has obtained approval for 31 new products, bringing the total number of products that have either passed or are deemed to have passed the consistency evaluation to 111 specifications across 82 product varieties.
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