Great news! Two specifications of the group’s Urapidil Hydrochloride Injection have been approved simultaneously.


Time:2023-06-02

On June 1, just one day after the approval of tedizolid phosphate for injection, two specifications of urapidil hydrochloride injection—5 ml: 25 mg and 10 ml: 50 mg—submitted by Shijiazhuang Fourth Pharmaceutical Group simultaneously obtained drug production registration approvals from the National Medical Products Administration and are deemed to have passed the consistency evaluation. It is understood that this is the group’s 31st new product approved this year.
On June 1, just one day after the approval of tedizolid phosphate for injection, two specifications of urapidil hydrochloride injection—5 ml: 25 mg and 10 ml: 50 mg—submitted by Shijiazhuang Fourth Pharmaceutical Group simultaneously obtained drug production registration approvals from the National Medical Products Administration and are deemed to have passed the consistency evaluation. It is understood that this marks the group’s 31st new product approved this year.
It is reported that Urapidil Hydrochloride Injection is primarily used for the treatment of hypertensive crises (such as a sudden and dramatic rise in blood pressure), severe and extremely severe hypertension, and refractory hypertension.
Previously, the group’s application for uradil hydrochloride active pharmaceutical ingredient had already been approved by the National Medical Products Administration and registered as an API intended for use in marketed formulations. The approval of this uradil hydrochloride injection will inject new vitality into the group’s market development of this product.
Relevant officials from the group’s R&D center stated that in recent years, the group has been implementing an integrated development strategy of “active pharmaceutical ingredients (APIs) + finished dosage forms.” Actively aligning the innovation chain with the industrial chain, the group has continuously accelerated the research and development of related finished dosage form products based on its already approved APIs, thereby strongly supporting the company in focusing its efforts precisely, enhancing awareness, and improving the quality and efficiency of its finished dosage form operations. As of now, the group has a cumulative total of 49 varieties and 64 specifications of products that have either passed or are deemed to have passed the national evaluation for consistency in quality and efficacy of generic drugs. These innovative achievements have entered a concentrated “harvest period,” powerfully propelling Shijiazhuang Fourth Pharmaceutical into a fast track of high-quality development.
 

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