News Center

位置：

Honors Announcement

Group News

Media Reports

Good News! Four New Pharmaceutical Preparations from Shijiazhuang Sihua Pharmaceutical Group Approved on the Same Day

Category:

Honors Announcement

发布时间：2025-09-01

【概要描述】 Innovation is surging forward with unstoppable momentum. On September 1, four new dosage-form products developed and submitted for approval by Shijiazhuang Sihua Pharmaceutical Group—the Category 3 chemical drug allopurinol tablets (0.1 g), urapidil sustained-release capsules (30 mg), nicardipine hydrochloride sodium chloride injection (200 ml), and the Category 4 chemical drug drotaverine hydrochloride injection (2 ml: 40 mg)—all received manufacturing registration approvals from the National Medical Products Administration on the same day and are deemed to have passed the consistency evaluation. Notably, urapidil sustained-release capsules and nicardipine hydrochloride sodium chloride injection were the first of their kind in China to be approved. To date this year, the Group has secured approval for a total of 59 new products, including 44 dosage-form products, bringing the cumulative…

Good News! Four New Pharmaceutical Preparations from Shijiazhuang Sihua Pharmaceutical Group Approved on the Same Day

Innovation is gaining unstoppable momentum. On September 1, four new dosage-form products developed and submitted for approval by Shijiazhuang Sihua Pharmaceutical Group—the Category 3 chemical drug allopurinol tablets (0.1 g), urapidil sustained-release capsules (30 mg), nicardipine hydrochloride sodium chloride injection (200 ml), and the Category 4 chemical drug drotaverine hydrochloride injection (2 ml: 40 mg)—all received manufacturing registration approvals from the National Medical Products Administration on the same day and are deemed to have passed the consistency evaluation. Notably, urapidil sustained-release capsules and nicardipine hydrochloride sodium chloride injection were the first of their kind in China to be approved. To date this year, the Group has secured approval for a total of 59 new products, including 44 dosage-form products, bringing the cumulative total to 145 drug varieties and 192 product specifications that have either passed or are deemed to have passed the consistency evaluation.

According to available information, allopurinol tablets are indicated for the treatment of primary or secondary gout—including acute attacks, tophi, joint destruction, uric acid stones, and/or renal disease—as well as for patients with recurrent calcium oxalate stones. Urapidil sustained-release capsules, an α-receptor antagonist antihypertensive agent, are suitable for primary hypertension, renovascular hypertension, hypertension caused by pheochromocytoma, or urinary dysfunction associated with benign prostatic hyperplasia. Nicardipine hydrochloride sodium chloride injection is a selective calcium channel blocker indicated for the emergency management of intraoperative hypertensive crises or hypertensive emergencies. Drotaverine hydrochloride injection is used to treat smooth muscle spasms associated with biliary tract disorders (such as gallstones and bile duct stones, as well as cholecystitis and cholangitis) and urological disorders (such as renal and ureteral stones, pyelonephritis, and cystitis), and may also be employed as an adjunctive therapy for smooth muscle spasms resulting from gastrointestinal diseases (including gastric and duodenal ulcers, gastritis, enteritis, colitis, and other inflammatory conditions) and for the relief of dysmenorrhea.

Previously, Hebei Guangxiang Pharmaceutical Co., Ltd., a subsidiary of the Group, received approval in May 2023 for urapidil API and subsequently obtained approvals in March, April, and August 2025 for four additional APIs: nicardipine hydrochloride, allopurinol, and drotaverine hydrochloride. The recent approvals for four new finished dosage forms—urapidil sustained-release capsules, allopurinol tablets, nicardipine hydrochloride sodium chloride injection, and drotaverine hydrochloride injection—will further underscore the advantages of the Group’s integrated “API-plus-formulation” development model and enhance the market competitiveness of its products.

In recent years, the Group has focused on “newness,” leveraging technological innovation as its guiding force to tackle cutting-edge challenges in the industry and meet market demands. It has continuously advanced the strategic planning and development of specialty generic drugs and active pharmaceutical ingredients, resulting in a steady accumulation of innovative achievements and an ever-expanding pipeline of new products. The recent approval of four new dosage-form products not only signals that the company’s innovation pipeline has entered a phase of intensive translation into commercial outcomes, fully demonstrating its innovative capabilities, but also creates favorable conditions for enhancing product accessibility.

Keywords:

Attention! Shijiazhuang Sihua Pharmaceutical Group Receives Approval for Seven New Finished-Product Formulations on the Same Day, Bringing the Total Number of Newly Approved Products This Year to 66

Shijiazhuang Sihua Pharmaceutical Group’s Benidipine Hydrochloride Tablets Approved

Attention! Shijiazhuang Sihua Pharmaceutical Group Receives Approval for Seven New Finished-Product Formulations on the Same Day, Bringing the Total Number of Newly Approved Products This Year to 66

Shijiazhuang Sihua Pharmaceutical Group’s Benidipine Hydrochloride Tablets Approved