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Guangxiang Pharmaceutical of Shijiazhuang Sihua Pharmaceutical Group Receives Approval for Drotaverine Hydrochloride
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发布时间：2025-08-07
【概要描述】
On August 6, the tetrahydrozoline hydrochloride active pharmaceutical ingredient developed by Hebei Guangxiang Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, was approved by the National Medical Products Administration and registered as an API for use in marketed dosage forms.
On August 6, the ropivacaine hydrochloride API developed by Hebei Guangxiang Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, was approved by the National Medical Products Administration and registered as an API for use in marketed dosage forms.
According to available information, drotaverine hydrochloride is indicated for the treatment of 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 calculi, and pyelonephritis and cystitis). It is also used as an adjunctive therapy for smooth-muscle spasms caused by gastrointestinal disorders (including gastric and duodenal ulcers, gastritis, enteritis, colitis, and other inflammatory conditions) and for the relief of dysmenorrhea.
In recent years, the Group has demonstrated strong momentum in its integrated “API–formulation” development model, effectively facilitating the continuous translation of corporate innovation into commercial success. Since the beginning of this year, a total of 12 new API products have been approved, with Guangxiang Pharmaceutical accounting for 8 of these approvals. To date, the Group holds a portfolio of 79 bulk and specialty APIs, further strengthening its supply-chain resilience and capability.
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Non-Commercial (Filing) – 2025-0091