News & Events
On August 23, Lexenpharm (Suzhou) Co., Ltd. ("The Company") received an official notification from the U.S. Food and Drug Administration ("FDA"), stating that the Company's manufacturing facility meets the requirements of U.S. CGMP regulations and is ready for commercial manufacturing. This signifies that Lexenpharm's inhalation formulation production line (utilizing Blow-Fill-Seal technology or "BFS") has successfully passed the Pre-Approval Inspection ("PAI") by the FDA, making Lexenpharm the first China-based BFS sterile manufacturing plant to obtain this qualification.
In mid-June, a team of FDA investigators conducted a 7-day on-site pre-approval inspection of Lexenpharm's manufacturing facility based in Suzhou Industrial Park. They carried out a detailed and thorough evaluation of the Company's quality management system, facility and equipment system, pharmaceutical material system, production system, packaging and labeling system, and laboratory control system. The successful result of this inspection is a verification of Lexenpharm's world-leading quality standard in GMP compliance. The Company has rigorously implemented standardization, proceduralization, and normative management according to CGMP guidelines. This is a major milestone in the Company's pursuit of expansion into international markets, enhancing its global competitiveness and laying a solid foundation for future international collaborations.
The Company is based in Suzhou and specializes in the R&D and manufacturing of pharmaceutical products for respiratory and eye diseases. It has currently built the Asia's largest aseptic drug products facility with 'Blow-Fill-Seal' technology. In addition, Lexenpharm is building an organ-target delivery technology platform. The Company continues to pursue its mission "To provide high-quality, cost-effective, and efficacious pharmaceutical products and innovative treatment solutions for patients worldwide".
The foundation ceremony for Lexenpharm (Suzhou) Co., Ltd. was held on January 11, 2022 in Suzhou Industrial Park. Upon completion, the project will become Asia's largest aseptic manufacturing facility based on the 'Blow-Fill-Seal (BFS)' technology.
The company already has a 6,700-square-meter production facility in the Biopharmaceutical Industrial Park. The facility has been strictly built in accordance with FDA CGMP and NMPA cGMP standards. The annual production capacity is approximately 120 million units of sterile vials.
Lexenpharm has been investing a total investment of 750 million RMB for the new manufacturing facility that has an area of 37 acres, with a total construction area of approximately 57,000 square meters. The new facility. after completion will become the Asia's largest sterile BFS manufacturing plant with annual production capacity of 1.5 billion vials.
Between 2021 and 2022, Lexenpharm has submitted three ANDA applications to FDA and five ANDAs applications to NMPA.
The manufacturing facilities was successfully passed the PAI inspections by NMPA in May 2022 and March 2023. Recently the manufacturing facility was also successfully passed the FDA PAI inspection in June, 2023, enabling the company's high-quality drug products to enter the international market.
