齐鲁制药(海南)通过日本PMDA认证

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]