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New Launch! Shijiazhuang Sihua Pharmaceutical Group’s Vitamin B6 Injection Has Passed the Consistency Evaluation

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Honors Announcement

发布时间：2025-10-31

【概要描述】 On October 31, the Vitamin B6 Injection (1 ml: 0.1 g) submitted by Shijiazhuang Sihua Pharmaceutical Group passed the National Medical Products Administration’s evaluation of generic drug quality and therapeutic equivalence, marking the group’s 75th new product approval so far this year.

New Launch! Shijiazhuang Sihua Pharmaceutical Group’s Vitamin B6 Injection Has Passed the Consistency Evaluation

On October 31, the Vitamin B6 Injection (1 ml: 0.1 g) submitted by Shijiazhuang Sihua Pharmaceutical Group passed the National Medical Products Administration’s evaluation of generic drug quality and therapeutic equivalence, marking the group’s 75th new product approval so far this year.

According to available information, vitamin B6 injection is a commonly used dosage form for clinical applications of vitamin B6, indicated for the prevention and treatment of vitamin B6 deficiency, as well as for the management of isoniazid poisoning. It is also employed to alleviate vomiting induced by pregnancy, radiation sickness, and anticancer drugs, and to treat seborrheic dermatitis, among other conditions. Additionally, it is used to supplement vitamin B6 in patients receiving total parenteral nutrition or those with malnutrition and progressive weight loss due to inadequate intake. Vitamin B6 injection is classified as a Category A drug under the National Medical Insurance Scheme. According to data from Mene.net, sales of this product in domestic public hospitals and primary-level public medical institutions reached approximately RMB 435 million in 2024.

In recent years, the Group has proactively positioned and developed product pipelines in therapeutic areas such as parenteral nutrition, anti-infectives, and fluid balance, continuously exploring new growth opportunities, cultivating new competitive advantages, and steadily expanding its product portfolio. To date, the Group has had a total of 155 drug varieties comprising 206 dosage forms either approved or deemed to have passed the Consistency Evaluation, which has not only significantly enhanced product accessibility but also provided robust assurance for meeting a broader range of clinical needs.

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Continuous New Product Launches: Shijiazhuang Sihua Pharmaceutical Group Receives Concurrent Approval for Four New Products—Formulation (Lincomycin Hydrochloride Injection) and Active Pharmaceutical Ingredients (Fenofibrate, Fenofibric Acid Choline, and Sodium Levofloxacin Phosphate)—on the Same Day

On the same day, two blockbuster products from Shijiazhuang Sihua Pharmaceutical Group—the levamlodipine besylate tablets (2.5 mg and 5 mg) and magnesium sulfate injection (5 mL: 2.5 mg)—received approval for expanded indications.