Lianhe Aigen passed the FDA audit inspection

Lianhe Aigen Pharma Co., Ltd. (formerly known as Lianhe Chemical Technology (Taizhou) Co., LTD.) is located at No. 3 Donghai 8th Avenue, Toumengang New District, Linhai, Taizhou, Zhejiang, which is mainly customizes and produces pharmaceutical intermediates and API for customers. In July 2023, the company successfully passed the U.S. FDA's on-site PAI inspection for several apis with a result of 0-483 (zero defects).This indicates that the company's cGMP quality management system and production environment facilities have been recognized by the US government, which will bring new impetus to the customized production of the company's pharmaceuticals and expand the international market and improve the comprehensive competitiveness of the company's pharmaceutical business.

The successful passage of the US FDA certification is of great significance to Lianhe Aigen. This not only signifies the company's cGMP quality system has reached a higher level, but also will have a positive impact on the company's future development and business performance. The company will have the opportunity to obtain more advanced intermediates and API projects from strategic partners to further promote the company's development in the pharmaceutical field.

Lianhe Aigen will continue to uphold strict quality management concept, constantly improve product quality and service level, to provide customers with better products and solutions. At the same time, the company will also expand the international market actively, strengthen cooperation with global customers, and make greater contributions to promoting the development of the global pharmaceutical industry.