头孢丙烯片
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华北制药获得头孢丙烯片药品注册证书
Bei Jing Shang Bao· 2026-02-09 11:47
Core Viewpoint - North China Pharmaceutical (华北制药) announced that its wholly-owned subsidiary, Hebei Huamin Pharmaceutical Co., Ltd., received the drug registration certificate for Cefprozil Tablets (0.25g) from the National Medical Products Administration [1] Group 1: Company Information - The drug Cefprozil is a second-generation cephalosporin antibiotic, first developed by Bristol-Myers Squibb in 1991 [1] - Cefprozil is the first oral cephalosporin approved by the FDA for treating pediatric otitis media and sinusitis [1] - The drug was approved for market entry in China by the National Medical Products Administration in 1999 [1] Group 2: Product Details - The approved indication for Cefprozil in China is for the treatment of mild to moderate infections caused by sensitive bacteria [1]
华北制药(600812.SH):下属公司头孢丙烯片获得《药品注册证书》
Ge Long Hui A P P· 2026-02-09 09:20
Core Viewpoint - North China Pharmaceutical (600812.SH) announced that its wholly-owned subsidiary, Hebei Huamin Pharmaceutical Co., has received the drug registration certificate for Cefprozil tablets (0.25g) from the National Medical Products Administration, marking a significant development in its antibiotic portfolio [1] Group 1: Product Approval - The drug Cefprozil is classified as a second-generation cephalosporin antibiotic [1] - The approved indications for Cefprozil in China include treatment for mild to moderate infections caused by sensitive bacteria, such as upper respiratory infections, lower respiratory infections, and skin and soft tissue infections [1] Group 2: Indications - Specific approved indications include: 1. Upper respiratory infections: Streptococcal pharyngitis/tonsillitis, otitis media, and acute sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis [1] 2. Lower respiratory infections: Acute bronchitis and exacerbations of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis [1] 3. Skin and soft tissue infections: Non-complicated infections caused by Staphylococcus aureus and Streptococcus pyogenes, with the note that abscesses may require surgical drainage [1]
华北制药:下属公司头孢丙烯片获得《药品注册证书》
Ge Long Hui· 2026-02-09 09:16
Core Viewpoint - North China Pharmaceutical (600812.SH) announced that its wholly-owned subsidiary, Hebei Huamin Pharmaceutical Co., has received the drug registration certificate for Cefprozil tablets (0.25g) from the National Medical Products Administration, indicating a significant regulatory approval for a new antibiotic product [1] Group 1: Product Approval - The drug Cefprozil is classified as a second-generation cephalosporin antibiotic [1] - The approved indications for Cefprozil in China include treatment for mild to moderate infections caused by sensitive bacteria, such as upper respiratory infections, lower respiratory infections, and skin and soft tissue infections [1] Group 2: Indications - For upper respiratory infections, Cefprozil is indicated for conditions like streptococcal pharyngitis/tonsillitis and acute otitis media caused by Streptococcus pneumoniae and Haemophilus influenzae [1] - In lower respiratory infections, it is used for acute bronchitis secondary to bacterial infections and acute exacerbations of chronic bronchitis [1] - The drug is also indicated for non-complicated skin and soft tissue infections caused by Staphylococcus aureus and streptococci, although abscesses typically require surgical drainage [1]
华北制药:子公司头孢丙烯片获得药品注册证书
Xin Lang Cai Jing· 2026-02-09 09:12
Core Viewpoint - Huabei Pharmaceutical's subsidiary Huamin Company has received approval from the National Medical Products Administration for the registration of Cefprozil Tablets (0.25g), a second-generation cephalosporin antibiotic used for mild to moderate infections caused by sensitive bacteria [1] Group 1 - The registration certificate for Cefprozil Tablets was obtained on February 9, 2026, after the application was submitted in October 2024 [1] - The total research and development investment for this product amounted to 14.6458 million yuan [1]