News Center
Lizhu Fuxing has passed the German GMP certification.
Release time:
2013-06-03
Lizhu Fuxing has passed the German GMP certification.
From May 23 to 27, German inspectors successfully completed a rigorous on-site inspection over five days, passing the strict audit of the German GMP for the two raw materials, Vancomycin and Teicoplanin, produced by Lizhu Group Fuxing Company, and were unanimously certified.
German inspectors fully recognized that the Vancomycin and Teicoplanin products produced by Lizhu Fuxing meet the Warranty system for sales to the German and EU markets. Thus, after passing the US FDA, Lizhu Fuxing's Vancomycin has also successfully passed the EU GMP, fully opening the door to the regulated market. Teicoplanin, as the first product to pass the new quality standards soon to be implemented in the EU, has established a competitive advantage. The successful passage of these two products through the EU GMP further solidifies the core competitiveness of Lizhu Fuxing's anti-drug-resistant product line.
In clinical treatment, drug-resistant G+ (Gram-positive bacteria) exhibit multiple drug resistance, and many antibiotics are ineffective against them. However, Vancomycin and Teicoplanin, due to their unique bactericidal mechanisms, are the most effective weapons for treating such resistant bacteria. With the widespread use of antibiotics, the infection rates of multi-drug-resistant bacteria, especially MRSA and MRSE, continue to rise.In recent years, Lizhu Fuxing Company has established the development of anti-drug-resistant antibiotics as its key direction. In addition to the industrial production of Vancomycin and Teicoplanin, several other anti-drug-resistant antibiotic varieties are under intensive development. With the certification of these two varieties by the EU, the company will actively cooperate with EU pharmaceutical companies in various forms to strengthen and expand these two varieties in the EU regulated market.
With this EU certification, Lizhu Fuxing expects the sales of Vancomycin and Teicoplanin to double in 2013.
From the perspective of group strategy, in recent years, Lizhu Group has actively applied for international certifications for both formulation products and raw materials, accepted strict quality reviews, and held itself to the quality standards of the regulated market, laying a solid foundation for ultimately entering the international mainstream market and making full preparations.
Related Information