Guangxiang Pharmaceutical of Shijiazhuang Sihua Pharmaceutical Group Receives Approval for Drotaverine Hydrochloride
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TIME:2025-08-07

On August 6, the active pharmaceutical ingredient of drotaverine hydrochloride 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 stones, 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 79 bulk and specialty API varieties, further strengthening its supply-chain resilience and capability.
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