坎地沙坦酯氢氯噻嗪片(Ⅱ)
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福元医药:坎地沙坦酯氢氯噻嗪片(Ⅱ)获得药品注册证书
智通财经网· 2025-09-29 08:12
Core Viewpoint - Fuyuan Pharmaceutical (601089.SH) has received a drug registration certificate from the National Medical Products Administration for Candesartan Cilexetil and Hydrochlorothiazide Tablets, allowing the production of this combination medication [1] Group 1: Product Approval - The drug Candesartan Cilexetil and Hydrochlorothiazide is a combination of an angiotensin II receptor inhibitor and a diuretic, approved for production in China [1] - The product is indicated for adults with primary hypertension who do not achieve effective blood pressure control with either Candesartan Cilexetil or Hydrochlorothiazide alone, or as a substitute for the combination therapy at the same dosage [1] Group 2: Historical Context - The drug was co-developed by Takeda and AstraZeneca, first launched in Sweden in June 1998, and received FDA approval in the United States in September 2000 [1] - Currently, the original manufacturer’s version of Candesartan Cilexetil and Hydrochlorothiazide Tablets is not available in the Chinese market [1]
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
智通财经网· 2025-09-29 08:09
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]
华海药业:两款产品获得药品注册证书
Zhi Tong Cai Jing· 2025-09-16 09:21
Core Viewpoint - Huahai Pharmaceutical has received approval from the National Medical Products Administration for the registration of two new drugs, which will enhance its product line and market competitiveness [1] Group 1: Regulatory Approval - The company has obtained the drug registration certificates for Candesartan Cilexetil and Rosatadine Acetate Injection from the National Medical Products Administration [1] - These drugs are classified as Category 3 chemical drugs, which are considered to have passed the consistency evaluation according to national policies [1] Group 2: Business Impact - The approval of these new drugs will enrich the company's product portfolio [1] - This development is expected to positively impact the company's operational growth and market competitiveness [1]
华海药业(600521.SH):两款产品获得药品注册证书
智通财经网· 2025-09-16 09:20
Core Viewpoint - Huahai Pharmaceutical has received approval from the National Medical Products Administration for the registration of two new drugs, which will enhance its product line and market competitiveness [1] Group 1: Regulatory Approval - The company has obtained the drug registration certificates for Candesartan Cilexetil and Rosatadine Hydrochloride Injection from the National Medical Products Administration [1] - These drugs are classified as Category 3 chemical drugs, which are considered to have passed the consistency evaluation according to national policies [1] Group 2: Business Impact - The approval of these new drugs will enrich the company's product portfolio [1] - This development is expected to positively impact the company's operational growth and market competitiveness [1]
华海药业(600521.SH):获得药品注册证书
Ge Long Hui A P P· 2025-09-16 09:16
Core Viewpoint - Huahai Pharmaceutical (600521.SH) has received approval from the National Medical Products Administration for the drug registration certificates of Candesartan Cilexetil and Hydrochlorothiazide Tablets (II) and Injectable Ranitidine Acetate, indicating a significant advancement in its product portfolio for hypertension treatment [1] Group 1: Product Approval - The company has obtained the drug registration certificate for Candesartan Cilexetil and Hydrochlorothiazide Tablets (II), which is intended for the treatment of hypertension [1] - This product is not suitable for initial treatment of hypertension but is applicable for adults with primary hypertension whose blood pressure cannot be effectively controlled by either Candesartan Cilexetil or Hydrochlorothiazide alone, or as a replacement therapy for the combination of both drugs at the same dosage [1]