Founded in 2001, Lijian Pharmaceutical is a comprehensive pharmaceutical enterprise designed and constructed in line with EU GMP standards, and also a National High-Tech Enterprise of China. We operate two modern R&D and manufacturing bases located in Shenzhen and Nanchang, China, covering a total plant area of over 101,000 square meters. The company employs more than 2,000 full-time staff and boasts a large team of specialists with decades of hands-on experience in R&D, regulatory registration, manufacturing and quality management systems. We focus on the R&D, manufacturing and commercialization of cephalosporin antibiotics, antitussive medicines, blood glucose regulators and other pharmaceutical products. Meanwhile, Lijian provides professional CMO, CDMO and BD cooperation services for our partners.
As China’s first manufacturer of non-terminally sterilized preparations to obtain EU GMP certification, we have successfully passed official EU GMP audits conducted by German authorities eight times consecutively over the past two decades. Lijian is also the first Chinese pharmaceutical enterprise to implement the Qualified Person system in full compliance with EU standards. We have established a four-tier quality control system covering incoming raw material inspection, in-process control, finished product release and post-marketing stability tracking, ensuring full quality control and complete traceability throughout the entire chain from manufacturing to distribution. We own a large portfolio of formulation and manufacturing process patents, backed by robust R&D capabilities. Our regulatory registration team possesses extensive hands-on experience of product registration across numerous countries in Europe, Asia and other regions worldwide, and is ready to supply all required technical documentation for clients and regulatory authorities upon request.
Our product portfolio covers seven core therapeutic areas with more than 100 commercially available products. We support rapid technology transfer and CMO supply, and deliver full one-stop CDMO services for partners.Our workshops feature ample production capacity: annual output reaches 533 million vials of injectable preparations and 872 million units of oral dosage forms. We offer customized manufacturing to meet client requirements and rapidly fulfill large-volume bulk orders.Core production lines are equipped with European imported equipment and automation, enabling us to provide products with competitive pricing. All manufacturing and supply activities are carried out in strict accordance with EU GMP standards, delivering consistent batch-to-batch product quality. Our quality management system aligns with regulatory requirements of overseas markets, which can effectively shorten our clients’ product registration and market launch timelines.
