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药品制造商Strides塞来昔布胶囊(100mg、200mg和400mg)获FDA批准,增强了抗炎产品组合

Strides Strengthens Anti-Inflammatory Portfolio with USFDA Approval for Celecoxib Capsules, 100 mg, 200 mg, and 400 mg

Medgate Today 等信源发布 2025-05-01 21:22

可切换为仅中文


Celecoxib Capsules approval complements Strides’ existing products to serve a broader patient base

塞来昔布胶囊的批准补充了Strides现有产品,以服务更广泛的患者群体。

Strides Pharma Science Limited (Strides) today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Celecoxib Capsules, 100 mg, 200 mg, and 400 mg, from the United States Food & Drug Administration (USFDA).

斯特里德斯制药科学有限公司(Strides)今天宣布,其全资子公司新加坡斯特里德斯制药全球私人有限公司已获得美国食品药品监督管理局(USFDA)对塞来昔布胶囊100毫克、200毫克和400毫克的批准。

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Celebrex® Capsules, 100 mg, 200 mg, and 400 mg, of Upjohn US 2 LLC.

该产品与参比制剂(RLD)Celebrex®胶囊(100毫克、200毫克和400毫克,Upjohn US 2 LLC公司生产)具有生物等效性和治疗等效性。

The approval of Celecoxib Capsules strengthens Strides’ portfolio in the anti-inflammatory therapeutic segment. This approval complements the company’s existing products in the same therapy area and enhances its ability to serve a broader patient population with effective, affordable treatment options.

塞来昔布胶囊的获批增强了Strides在抗炎治疗领域的实力。这一批准补充了该公司在同一治疗领域现有的产品,并提升了其通过有效且价格合理的治疗方案服务更广泛患者群体的能力。

Celecoxib is a selective COX-2 inhibitor used for the management of pain and inflammation associated with various conditions including osteoarthritis, rheumatoid arthritis, acute pain, and dysmenorrhea. Celecoxib Capsules, 100 mg, 200 mg, and 400 mg have a combined market size of ~US$ 116 Mn as per IMS..

塞来昔布是一种选择性COX-2抑制剂,用于治疗与各种疾病相关的疼痛和炎症,包括骨关节炎、类风湿性关节炎、急性疼痛和痛经。根据IMS的数据,100毫克、200毫克和400毫克的塞来昔布胶囊的总市场规模约为1.16亿美元。

The product will be manufactured at the company’s facility in Puducherry.

该产品将在公司位于本地治里的工厂生产。