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Shijiazhuang Sihua Pharmaceutical Group’s dapagliflozin/metformin extended-release tablets (I) and arginine ibuprofen granules (0.2 g/0.4 g) — three new products — were approved on the same day.

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Honors Announcement

发布时间：2025-04-22

【概要描述】 Recently, three new products submitted by Shijiazhuang Sihua Pharmaceutical Group—the Class 4 chemical drug dapagliflozin/metformin extended-release tablets (I) and arginine ibuprofen granules (0.2 g/0.4 g)—received drug production registration approvals from the National Medical Products Administration on the same day, and are deemed to have passed the consistency evaluation. To date this year, the Group has obtained approval for 20 new dosage-form products, bringing the total number of approved and evaluated products to 168 specifications across 124 varieties.

Shijiazhuang Sihua Pharmaceutical Group’s dapagliflozin/metformin extended-release tablets (I) and arginine ibuprofen granules (0.2 g/0.4 g) — three new products — were approved on the same day.

Recently, three new products submitted by Shijiazhuang Sihua Pharmaceutical Group—the Class 4 chemical drug dapagliflozin/metformin extended-release tablets (I) and arginine ibuprofen granules (0.2 g/0.4 g)—were granted drug production registration approvals by the National Medical Products Administration on the same day, and are deemed to have passed the consistency evaluation. To date this year, the Group has received approval for 20 new dosage-form products, bringing the total number of products that have passed the consistency evaluation to 168 specifications across 124 varieties.

According to available information, dapagliflozin/metformin extended-release tablets (Formulation I) are a combination formulation that integrates the benefits of both dapagliflozin and metformin, representing a major breakthrough in diabetes pharmacotherapy in recent years. When used in conjunction with dietary management and exercise, this medication is indicated for adult patients with type 2 diabetes who are already receiving dapagliflozin and metformin hydrochloride therapy to improve glycemic control. With the continued growth of China’s diabetes drug market, the combination regimen of “metformin plus other oral hypoglycemic agents” has increasingly attracted clinical attention. The recently approved dapagliflozin/metformin extended-release tablets (Formulation I) further enriches the company’s product portfolio in the field of antidiabetic medications.

Arginine ibuprofen granules are an over-the-counter antipyretic and analgesic medication that inhibits prostaglandin synthesis, thereby exerting antipyretic, analgesic, and anti-inflammatory effects. They are primarily indicated for the treatment of toothache, dysmenorrhea, pain resulting from trauma (such as sports injuries), joint and ligament pain, back pain, headache, neuralgia, and fever associated with influenza. According to data from MeneNet, in 2022 sales at the three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—totaled RMB 24.74 million; in 2023, sales amounted to RMB 20.46 million; and in the first half of 2024, sales reached RMB 8.15 million.

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