Core Viewpoint - The application for Roxithromycin suspension by Xinhua Pharmaceutical (Gaomi) Co., Ltd. has been accepted by the National Medical Products Administration on March 26, 2026, with acceptance number CYHB2600592 [1][3]. Company Information - Company Name: Xinhua Pharmaceutical (Gaomi) Co., Ltd. [2][5] - Established Date: December 29, 2000 [5] - Legal Representative: Xu Wenhui [5] - Industry: Biopharmaceutical Manufacturing [5] - Company Type: Limited Liability Company (non-natural person investment or holding) [5] - Company Size: Small [5] - Number of Employees: 239 [5] - Registered Capital: 19 million RMB [5] - Paid-in Capital: 19 million RMB [5] - Registered Address: No. 6, West High-tech Industrial Development Zone, Gaomi City, Weifang, Shandong Province [5]. Shareholder Information - Shareholder: Shandong Xinhua Pharmaceutical Co., Ltd. [5] - Shareholding Ratio: 100% [5] - Contributed Capital: 19 million RMB [5] - Contribution Date: May 10, 2012 [5] - First Shareholding Date: April 11, 2012 [5].

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) is set to disclose its 2025 annual report on March 30, with no significant undisclosed matters currently reported [2] Group 1 - The company announced the upcoming disclosure date for its annual report [2] - There are no major undisclosed matters that need to be reported at this time [2]

Group 1 - The core point of the article is that Ibuprofen granules have been included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2024 Edition) as a Class B product, indicating strong demand and clinical application for this common analgesic and antipyretic drug [1] - Ibuprofen is effective in alleviating mild to moderate pain, including headaches, joint pain, migraines, toothaches, muscle pain, neuralgia, and dysmenorrhea, and is also suitable for fever caused by common colds or influenza [1] - Xinhua Pharmaceutical, as a leading enterprise in the integrated production of ibuprofen raw materials and formulations in China, has established a complete ibuprofen industry chain from pharmaceutical intermediates to raw materials and formulations [1] Group 2 - The company has developed a diverse range of ibuprofen products, including ibuprofen tablets, ibuprofen pseudoephedrine tablets, ibuprofen suspension, ibuprofen sustained-release capsules, ibuprofen suspension drops, and the newly approved ibuprofen granules, catering to various clinical medication needs [1] - The company relies on a self-controlled raw material supply system, a strict and standardized quality management system, and continuous R&D innovation capabilities to enhance its ibuprofen product matrix [1] - Recently, Xinhua Pharmaceutical's subsidiary, Xinda Pharmaceutical, received approval from the National Medical Products Administration for the market launch of ibuprofen granules [2]

Group 1 - The core point of the article is that Xinhua Pharmaceutical has received approval for its Ibuprofen granules from the National Medical Products Administration [2] Group 2 - The approval was granted to Shandong Zibo Xinda Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Xinhua Pharmaceutical [2] - The issuance of the drug registration certificate marks a significant milestone for the company in expanding its product offerings [2]

Core Viewpoint - Xinhua Pharmaceutical announced that its wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., received the drug registration certificate for ibuprofen granules from the National Medical Products Administration, indicating a significant regulatory approval for a product aimed at pain relief and fever reduction [1] Company Summary - The approved ibuprofen granules are intended for alleviating mild to moderate pain, including headaches, joint pain, migraines, toothaches, muscle pain, neuralgia, and dysmenorrhea [1] - The product can also be used to reduce fever caused by common colds or influenza [1]

Group 1 - Core viewpoint: Xinhua Pharmaceutical (SZ 000756) announced that its wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has received the drug registration certificate for Ibuprofen Granules from the National Medical Products Administration [1] Group 2 - Company announcement: The announcement was made on the evening of March 23, with the closing price of Xinhua Pharmaceutical at 13.96 yuan [1]

Group 1 - The core point of the article is that Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for its ibuprofen granules, which are intended to relieve mild to moderate pain and fever associated with common colds and influenza [1] - The ibuprofen granules are classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025 edition) [1] - The sales revenue for ibuprofen-related formulations in Chinese public medical institutions is projected to be approximately RMB 4.4 billion in 2024 [1] Group 2 - The approval of this product enhances the variety of ibuprofen formulations offered by the company, providing more medication options for patients [1]

Group 1 - The core point of the article is that Xinhua Pharmaceutical (000756.SZ) announced that its wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has received the drug registration certificate for ibuprofen granules from the National Medical Products Administration [1] Group 2 - The approval of the ibuprofen granules indicates a significant regulatory milestone for the company, potentially enhancing its product portfolio and market competitiveness [1] - This development may lead to increased revenue opportunities for the company as it expands its offerings in the pharmaceutical market [1] - The registration of ibuprofen granules aligns with the company's strategy to innovate and diversify its pharmaceutical products [1]

Group 1 - The core point of the article is that Xinhua Pharmaceutical (000756.SZ) announced that its wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has received the drug registration certificate for Ibuprofen granules from the National Medical Products Administration [1] Group 2 - The approval of the Ibuprofen granules registration certificate signifies a potential expansion in the company's product offerings [1] - This development may enhance the company's market position in the pharmaceutical industry, particularly in the analgesic segment [1] - The registration could lead to increased revenue opportunities for the company as it introduces the new product to the market [1]

证券代码：000756 证券简称：新华制药 公告编号：2026-08 山东新华制药股份有限公司 关于子公司获得布洛芬颗粒药品注册证书的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记载、误导性陈 述或重大遗漏。 近日，山东新华制药股份有限公司（以下简称"公司"）之全资子公司山东淄博新达制药有限 公司（以下简称"新达制药"）收到国家药品监督管理局核准签发的布洛芬颗粒（以下简称"本品"） 《药品注册证书》。现将相关情况公告如下： 2023年12月，新达制药向国家药品监督管理局药品审评中心（CDE）递交布洛芬颗粒上市许可 注册申报资料并获受理，2026年3月获得《药品注册证书》，审评结论为批准注册。 1 剂型：颗粒剂 规格：0.2g 药品分类：非处方药 注册分类：化学药品3类 申请人：山东淄博新达制药有限公司 一、基本情况 药品名称：布洛芬颗粒 申请事项：药品注册（境内生产） 通知书编号：2026S00744 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品符合药品注册的 有关要求，批准注册，发给药品注册证书。同意本品按（甲类）非处方药管理。质量标准、说明 书、标签及生产 ...