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Urapidil Hydrochloride (API) Receives Marketing Authorization Approval Notice
2025-07-25
On July 6, 2025, the Active Pharmaceutical Ingredient (API) Urapidil Hydrochloride (hereinafter referred to as "the API") developed by Topfond Pharma successfully passed the technical review by the National Medical Products Administration (NMPA) and received the Chemical Drug Substance Marketing Authorization Approval Notice.
This API is primarily indicated for the treatment of hypertensive crises (such as a sharp rise in blood pressure), severe and very severe hypertension, as well as refractory hypertension; it is also used for controlling perioperative hypertension.
The approval of this API further solidifies the company's integrated API-formulation development strategy and lays a solid foundation for the subsequent production of Urapidil Hydrochloride Injection.
(Contributed by: Topfond Pharma Research Institute)
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