Completion and GMP Approval of the 3,000-ton-per-year Large-Particle Sodium Bicarbonate API Project

In March 2023, Qidu Pharmaceutical began the construction of its 3,000-ton-per-year large-particle sodium bicarbonate active pharmaceutical ingredient (API) project (Workshop 611). Covering an area of 4,000 m² with an investment of USD12.5 million, the project introduced over 100 advanced pieces of equipment, transforming patented technologies into commercial achievements.  

The new project features innovative designs in process flow, equipment selection, facility layout, and product packaging. With automated control systems enabling one-touch operation, the project reduces labor while improving efficiency. The space-saving vertical flow design ingeniously utilizes gravity to minimize material residue, reduce particle damage during transfer, and lower energy consumption in transportation.  

A pioneering packaging solution—FFS heavy-duty bags combined with whole-pallet cold-stretch film packaging—was introduced, marking the first application of its kind in China’s API industry and setting a new standard for domestic API packaging. Patent-protected equipment ensures uniform material distribution, effectively resolving issues of agglomeration and clogging, guaranteeing smooth operation throughout the entire process. Most of the key equipment was independently developed, making it the world’s first of its kind. This production line represents the highest level of automation and intelligence in China’s sodium bicarbonate API manufacturing.  

Workshop 611 commenced production in February 2024. On August 5, 2024, the sodium bicarbonate API successfully obtained an "A" registration status, meeting the highest domestic quality standards. By December 4 of the same year, it had passed the GMP compliance inspection.  

Upon operation, Qidu Pharmaceutical refused to engage in industry sales control or market monopolization, helping to stabilize prices, significantly reducing manufacturing costs for pharmaceutical companies, and alleviating the financial burden on patients. Moreover, breakthroughs in key crystallization technology have elevated the production quality of domestic sodium bicarbonate APIs, enhancing China’s global brand influence in this sector. The project has driven technological advancement and quality improvements in the industry, making a significant contribution to innovation in the pharmaceutical field.