福元医药(601089.SH)：坎地沙坦酯氢氯噻嗪片(Ⅱ)获得药品注册证书

Core Viewpoint - The company FuYuan Pharmaceutical (601089.SH) has received a drug registration certificate from the National Medical Products Administration for its product, Candesartan Cilexetil and Hydrochlorothiazide Tablets, indicating approval for production [1] Group 1: Product Details - The approved product is a combination formulation containing 16mg of Candesartan Cilexetil and 12.5mg of Hydrochlorothiazide per tablet [1] - This formulation is a combination of an angiotensin II receptor inhibitor (Candesartan Cilexetil) and a diuretic (Hydrochlorothiazide) [1] - The original developers of this drug are Takeda and AstraZeneca, with the product first launched in Sweden in June 1998 and receiving FDA approval in the United States in September 2000 [1] Group 2: Market Context - The original manufacturer’s version of Candesartan Cilexetil and Hydrochlorothiazide Tablets has not yet been launched in China [1] - The product is not intended for initial treatment of hypertension but is suitable for adults with primary hypertension who do not achieve effective blood pressure control with either Candesartan Cilexetil or Hydrochlorothiazide alone, or as a substitute treatment at the same dosage for the combination of both drugs [1]