TUL obtained the EU GMP certificate for antibiotic sterile APIs

The production of Amoxicillin Sodium, Ampicillin Sodium, Clavulanate Potassium, Sulbactam Sodium and mixed powder varieties of antibiotic sterile APIs of Zhuhai United Laboratories Co., Ltd. passed the official inspection of the Spanish Drug and Health Products Administration (AEMPS), and obtained the GMP compliance certificate officially issued by Spain on September 1, 2022.

TUL insists on implementing drug production quality management in accordance with international advanced GMP standards, and takes the road of international development. Its products have successively passed the GMP certification inspection of exporting countries, and obtained the pass to enter the international market. In the European market, the certification of sterile raw materials such as amoxicillin sodium by the company has been passed since 2011. After multiple GMP inspections by EU countries and CEP inspections by the European Medicines Quality Management Agency (EDQM), the new production line has passed another inspection along with the original certified production line. In addition, the company's non sterile raw materials such as amoxicillin and ampicillin have continuously passed GMP certification inspections in EU countries since 2006.

The EU GMP certification has significant influence globally and is regarded as the "passport" for drugs to enter the international market. The results of GMP inspections among EU member states are mutually recognized and shared with each other, as well as with countries such as Japan, the United States, Australia, and Canada. Passing EU GMP certification is a reliable recognition of the production strength and product quality of pharmaceutical enterprises. UL will continue to improve and enhance the level of production quality management and GMP implementation, and provide safe and effective drugs to the market.