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Good News Abounds: Shijiazhuang Sihua Pharmaceutical Group’s Esmolol Hydrochloride Injection and Deferiprone API Approved on the Same Day

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Honors Announcement

发布时间：2024-06-29

【概要描述】 On June 28, Shijiazhuang Sihua Pharmaceutical Group received production registration approval for its Class 3 chemical drug—Esmolol Hydrochloride Injection (10 mL: 0.1 g)—which is also deemed to have passed the consistency evaluation. This follows the June 18 approval of Esmolol Hydrochloride Sodium Chloride Injection (100 mL), marking another product in the group’s Esmolol portfolio to receive regulatory clearance. On the same day, the group’s Hebei Guolong Pharmaceutical Co., Ltd. obtained approval from the National Medical Products Administration for delarotinib, which has been registered as an active pharmaceutical ingredient for use in marketed dosage forms. Since the beginning of this year, the group has secured approval for 46 new products, with R&D quality and efficiency surpassing last year’s levels.

Good News Abounds: Shijiazhuang Sihua Pharmaceutical Group’s Esmolol Hydrochloride Injection and Deferiprone API Approved on the Same Day

On June 28, Shijiazhuang Sihua Pharmaceutical Group received production registration approval for its Class 3 chemical drug—Esmolol Hydrochloride Injection (10 mL: 0.1 g)—which is also deemed to have passed the consistency evaluation. This follows the June 18 approval of Esmolol Hydrochloride Sodium Chloride Injection (100 mL), marking another product in the group’s Esmolol portfolio to receive regulatory clearance. On the same day, the group’s Hebei Guolong Pharmaceutical Co., Ltd. obtained approval from the National Medical Products Administration for its developed drug, Deferasirox, which has now been registered as an active pharmaceutical ingredient for use in marketed formulations. Since the beginning of this year, the group has secured approval for 46 new products, with R&D quality and efficiency surpassing last year’s levels.

According to available information, esmolol hydrochloride injection is primarily indicated for supraventricular tachycardia or non-compensatory sinus tachycardia, as well as intraoperative and postoperative tachycardia and/or hypertension. Data from MeneNet show that the main market for esmolol hydrochloride injection is at the level of public medical institutions—specifically urban public hospitals, county-level public hospitals, urban community health centers, and township health clinics—and in 2022 it ranked second among injectable antihypertensive drugs, maintaining a steady growth trend over the past five years. Deferasirox is mainly used in patients who develop iron overload due to long-term blood transfusions, such as those with thalassemia or other rare forms of anemia.

Innovation is surging, linking “pearls” into a “chain.” In recent years, Shijiazhuang Sihua Pharmaceutical Group has taken meeting public health needs and industrial-chain demands as its starting point, focusing on key therapeutic areas such as anti-infectives, respiratory diseases, neurological disorders, cardiovascular and cerebrovascular conditions, gastrointestinal diseases, anesthesia, and oncology. The company has continuously increased investment and deepened its strategic positioning, pursuing integrated development of active pharmaceutical ingredients and finished dosage forms to steadily expand and diversify its product pipeline. To date, the company boasts 321 finished dosage-form products, with a cumulative total of 89 products across 120 specifications having either passed or been deemed to have passed the consistency evaluation. It also offers 60 bulk and specialty API varieties, thereby powerfully propelling the company toward the mid- to high-end segments of the industry.

Keywords:

The overall technical application achievements of Guangxiang Pharmaceutical, a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, have reached the internationally advanced level.

Good News! Shijiazhuang Sihua Pharmaceutical Group’s Epinephrine and Betahistine Mesylate APIs Approved on the Same Day

The overall technical application achievements of Guangxiang Pharmaceutical, a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, have reached the internationally advanced level.

Good News! Shijiazhuang Sihua Pharmaceutical Group’s Epinephrine and Betahistine Mesylate APIs Approved on the Same Day