Hunan Xianshi Pharmaceutical Receives NMPA Marketing Approval for Two Strengths of Dapoxetine Hydrochloride Tablets
Release date:
2026-01-09
CHANGSHA, Jan 09, 2026 — Hunan Xianshi Pharmaceutical Co., Ltd. has obtained marketing authorization from the National Medical Products Administration (NMPA) for Dapoxetine Hydrochloride Tablets in two specifications: 30 mg and 60 mg.
Classified as a Category 4 chemical generic drug per China’s drug registration rules, the product is developed and manufactured in strict alignment with bioequivalence requirements against the reference listed originator drug in terms of quality and therapeutic effect, allowing it to serve as an alternative to the original formulation in clinical use.
Dapoxetine Hydrochloride Tablets are a specialized prescription medicine indicated for the treatment of male premature ejaculation. The drug regulates the ejaculatory reflex center with fast onset and targeted pharmacological effects, approved for symptomatic treatment in male patients aged 18 to 64 years old, and listed as a first-line therapeutic option in domestic and international clinical guidelines for premature ejaculation management.
The latest approval further expands Xianshi Pharmaceutical’s product portfolio. It marks important progress in the company’s layout across prescription and self-care pharmaceutical sectors and demonstrates its robust capacity in generic drug R&D and regulatory registration. Meanwhile, the new generic product enriches clinical medication options and better meets unmet patient treatment demands.
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