Focus on sprinting towards FDA and entering the global market with a high starting point

The injection grade methylprednisolone sodium succinate produced by Jinyao Pharmaceutical, a subsidiary of Jinyao Group, has passed the on-site inspection before the approval of the US FDA's Simplified New Drug Application (ANDA). Subsequently, Celecoxib capsules also obtained ANDA approval, which means that the drug has qualified for sale in the US market and has a positive impact on Jinyao Group's expansion into the US formulation market. At present, Jinyao Group has multiple products such as prednisone, spironolactone, dexamethasone, methylprednisolone, etc. that have passed the US FDA certification, and 8 products have obtained the European CEP certificate. The product sales network covers more than 50 countries and regions including Europe and America.

Challenges/initial situation

The raw material of celecoxib produced by Tianyao Co., Ltd., a subsidiary of Tianjin Jinyao Group, has passed the technical review of the Center for Drug Evaluation (CDE) of the National Medical Products Administration. Its formulated product celecoxib capsules were approved by the FDA (US Food and Drug Administration) to enter the US market in February 2020.

Solution/portfolio

The continuous monitoring system of Borong Environment adopts a wireless combined with wired architecture for implementation and stable operation.

With unique transmission stability and data redundancy, it ensures data integrity in catastrophic situations, scalable architecture, and excellent system performance, providing a strong foundation for cost reduction, efficiency improvement, stable operation, and convenient and rapid implementation of later supplementary monitoring point construction, installation, and verification. Customers can efficiently provide support when facing quality audits such as those conducted by the European Union.