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Good News! Shijiazhuang Sihua Pharmaceutical Group Receives Approval for Three New Products in Both API and Finished-Formulation Categories on the Same Day

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Honors Announcement

发布时间：2024-06-01

【概要描述】 Unremitting efforts have yielded one breakthrough after another. With three new products approved in a single day, Shijiazhuang Sihua Pharmaceutical Group continues to set new records in R&D innovation.

Good News! Shijiazhuang Sihua Pharmaceutical Group Receives Approval for Three New Products in Both API and Finished-Formulation Categories on the Same Day

Unremitting efforts yield one breakthrough after another. With three new products approved in a single day, Shijiazhuang Sihua Pharmaceutical Group continues to set new records in R&D innovation.

On May 30, Shijiazhuang Sihua Pharmaceutical Group obtained registration approval from the National Medical Products Administration for its peritoneal dialysis solution (lactate-based, 4.25%, 2,000 ml) and acetaminophen-mannitol injection (50 ml: 500 mg), both of which have either passed or are deemed to have passed the consistency evaluation. Notably, the acetaminophen-mannitol injection (50 ml: 500 mg) is the second such product in China to receive approval. Concurrently, the group’s Hebei Guolong Pharmaceutical Co., Ltd. also secured NMPA approval for its application to register trelagliptin succinate as an active pharmaceutical ingredient for use in marketed formulations.

According to available information, peritoneal dialysis solution (lactate–G4.25%) is primarily used in patients with chronic renal failure who are ineligible for non-dialysis therapies and therefore require continuous ambulatory peritoneal dialysis. Currently, the group has five approved formulations of peritoneal dialysis solution and low-calcium peritoneal dialysis solution that have passed the consistency evaluation, thereby better meeting diverse clinical needs. Acetaminophen-mannitol injection is indicated for the relief of fever in adults. Troglitazone succinate is a long-acting oral antidiabetic agent for type 2 diabetes.

Over the past two years, Shijiazhuang Sihua Pharmaceutical Group has conducted systematic benchmarking and focused its R&D efforts on key therapeutic areas, including anti-infectives, respiratory diseases, neurological disorders, cardiovascular and cerebrovascular conditions, gastroenterology, anesthesia, endocrinology, oncology, and dialysis. The company has continuously advanced integrated development of “active pharmaceutical ingredients plus finished dosage forms,” driving product iteration and innovation through sustained accumulation and gradual breakthroughs, resulting in a thriving portfolio of new products and significant achievements. Since the beginning of this year, the group has obtained approval for 37 new products, and a total of 85 drug varieties comprising 116 dosage forms have either passed or been deemed to have passed the consistency evaluation. The successive realization of these innovative outcomes has powerfully enabled the company to move up the value chain toward the mid- to high-end segments.

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Good News Abounds! Shijiazhuang Sihua Pharmaceutical Group’s Bisoprolol Amlodipine Tablets and Entacapone Tablets Have Been Approved

Shijiazhuang Sihua Pharmaceutical Group’s Sodium Bicarbonate Injection (50 mL: 4.2 g) Has Passed the Consistency Evaluation

Good News Abounds! Shijiazhuang Sihua Pharmaceutical Group’s Bisoprolol Amlodipine Tablets and Entacapone Tablets Have Been Approved

Shijiazhuang Sihua Pharmaceutical Group’s Sodium Bicarbonate Injection (50 mL: 4.2 g) Has Passed the Consistency Evaluation