GMP认证
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亿帆医药:合肥欣竹生产线近期才投入使用
Mei Ri Jing Ji Xin Wen· 2025-11-07 09:18
Core Viewpoint - The company Yifan Pharmaceutical has confirmed that the production line of Hefei Xinzhu has recently been put into operation and will disclose any updates regarding GMP certification in accordance with legal and regulatory requirements [1] Group 1 - Investors inquired about the status of domestic GMP certification for Xinzhu Bio and the expected timeline for FDA and EMA certifications [1] - Yifan Pharmaceutical stated that the Hefei Xinzhu production line has only recently started operations [1] - The company will provide timely announcements regarding any progress on GMP certification as required by law [1]
齐鲁制药(海南)通过日本PMDA认证
Hai Nan Ri Bao· 2025-10-17 02:21
Core Viewpoint - Qilu Pharmaceutical (Hainan) Co., Ltd. has successfully passed the GMP compliance inspection by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), which is a significant achievement for the company in terms of market access and credibility in the pharmaceutical industry [1] Group 1: Certification and Compliance - The PMDA is a key regulatory body in Japan, known for its rigorous and scientifically sound certification standards, which are recognized globally, particularly in Southeast Asia and the Middle East [1] - The successful GMP certification allows Qilu Pharmaceutical to legally enter the Japanese market and supports its expansion into the Asia-Pacific and global markets [1] Group 2: Audit and Evaluation - The PMDA conducted a four-day on-site audit in July, focusing on a specific sterile preparation product, assessing six major systems including quality management, production control, material management, laboratory management, equipment facilities, and packaging labeling [1] - The audit provided a comprehensive and strict review of the company's quality management system and entire production process [1] Group 3: Market Presence - Qilu Pharmaceutical holds the number one market share for 38 products in their respective export markets, with 33 formulations exported to the United States and 17 formulations to Europe [1] - The company's products are sold in over 100 countries and regions worldwide, indicating a strong global presence [1]
北陆药业:关于控股子公司海昌药业通过巴西国家卫生监督局GMP认证的公告
Zheng Quan Ri Bao Zhi Sheng· 2025-09-02 13:17
Core Viewpoint - Beilu Pharmaceutical announced that its subsidiary, Zhejiang Haichang Pharmaceutical Co., Ltd., has received official GMP certification from the Brazilian National Health Surveillance Agency [1]. Group 1 - The certification indicates that Haichang Pharmaceutical meets the required standards for drug production quality management [1]. - This development may enhance the company's credibility and market access in Brazil, potentially leading to increased sales and growth opportunities [1].
润博士Dr.rui:FDA认证的NAD+产品靠谱吗?如何避免智商税
Sou Hu Cai Jing· 2025-05-07 08:40
Core Insights - The article emphasizes the importance of understanding key factors when choosing NAD+ products, particularly focusing on the types of precursor substances used, namely NMN and NR, which have distinct characteristics affecting stability and absorption [1][3]. Group 1: Product Composition - The main NAD+ supplements contain either NMN or NR, with NMN having a larger molecular weight and potentially better stability, while NR has a smaller molecular weight and is theoretically easier to absorb [1]. - Quality products should clearly indicate the specific form and content of the precursors used [1]. Group 2: Production Process and Purity - The production process and purity of NAD+ precursors are crucial, with high-purity products typically produced through biological fermentation, which, although more expensive, ensures safety and purity [3]. - Consumers are encouraged to check for third-party testing reports that detail effective ingredient content, heavy metal residues, and microbial limits, with a purity level of 98% or higher being ideal [3]. Group 3: Certification and Pricing - Certification information is vital, as NAD+ supplements do not require the same rigorous approval as drugs; however, certifications like FDA's GRAS and GMP can provide assurance regarding safety and production standards [5]. - The market price for NAD+ products varies significantly, influenced by factors such as raw material source, purity level, dosage form, and brand premium, with consumers advised to avoid both the most expensive and excessively cheap options [5].