On January 21, Notai Biotech announced that the dry mixed suspension production line and granule production line in its Zhonghua Pharmaceutical Port factory (Workshop 203) recently received the "Drug GMP Compliance Inspection Notification" (Su Yao Jian Yao Sheng Gao [2025] 037 and [2025] 038) issued by the Jiangsu Provincial Drug Administration, passing the drug GMP compliance inspection.

The workshop is designed according to FDA/EMA standards and has introduced first-tier international brand equipment, including Glatt's wet granulation line, KILIAN's double-outlet tablet press, SYNTEGON's capsule filling machine, Glatt's coating machine, and CAM's automated packaging line. The designed annual production capacities are 4.5 billion tablets & hard capsules, 36 million bottles of oral dry mixed suspensions & granules, and 450 million bags of granules/powders. The workshop has passed completion acceptance.

Notai Biotech stated that the successful GMP compliance inspection of the dry mixed suspension and granule production lines indicates that the production lines meet the requirements of the "Good Manufacturing Practice for Drug Production," further enhancing the company's levels of green, intelligent, and large-scale operations, thereby ensuring product quality control and supply capacity. Currently, the company has achieved complete dosage form coverage for its key products, including Oseltamivir phosphate capsules, granules, and dry mixed suspensions, showcasing the company's core competitiveness in product iteration and upgrades, which has positive significance for the company’s future development.

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