XI’AN, China, Nov. 22 /Xinhua-PRNewswire/ -- Worldwide Biotech & Pharmaceutical Company (''WWBP’’) announced today that the company has been awarded the Good Manufacturing Practices (''GMP’’) Certificate on Nov. 4, 2004.
The GMP Certificate was awarded by the Chinese State Food and Drug Administration (SFDA, Chinese FDA), Shaanxi office. The SFDA is in charge of comprehensive supervision on the safety management of food and drugs and the competent authority of drug regulation. GMP is an absolutely necessary certificate that companies engaged in food and medicine production must have. As the result of adopting the regulation, it has forced 1,340 of 5,371 drug makers to close in China. With the GMP Certificate (Certificate No: Shan F0094), issued by State Drug Administration, WWBP is proved to be a manufacturer that complies with the requirements of the Chinese Good Manufacturing Practices for Pharmaceutical Products. By now, WWBP has already constructed a 5,359 square meter Good Manufacturing Practice (GMP) standard facility which is one of the few GMP compliant facilities for both biological and pharmaceutical products in China. The certificate allows WWBP to manufacture medical products including tablets, capsules and granules. It would also provide WWBP an opportunity to acquire larger market share on the drug manufacturing industry in China.
''It is so great that we passed the examination and finally obtained the GMP Certificate. Now we are qualified and this certificate really encourages us because firstly, it is very useful for improving the level of our production administration,’' said WenXia Guo, CEO and President of WWBP, ''secondly, and broadly speaking, it is a basic requirement to connecting our Chinese medicine producers together with the international quality standard system and successfully makes our products more competitive on the world market.’'
About Worldwide Biotech and Pharmaceutical Company
Worldwide Biotech & Pharmaceutical Co. (''WWBP’’) is a hi-tech biotech company with top-ranking pharmaceutical R&D abilities; Good Manufacturing Practices (GMP) licensed manufacturing facilities and well-established marketing network in China and Southeast Asia. The product range of WWBP covers Hepatitis C Virus (HCV) products, diagnostic medicines and Over-The- Counter (OTC) drugs. WWBP currently possesses of 35,940 square meter land and 5,359 square meter GMP standard facilities. With strong pharmaceutical R&D abilities especially in HCV field, WWBP has been known as the first biotech company in the world to hold the technology of culturing intact HCV in vitro by cell culture. Its principle project ''The intact hepatitis C virus (HCV) and method for culturing HCV in vitro by cell culture’’ was awarded Chinese Patent by China Patent Bureau and the prestigious China Patent Golden Metal by World Intellectual Property Organization and China Patent Bureau. The medal is the only one issued for achievement in the biomedical sciences during the past 10 years. WWBP has achieved a GMP production scale level of 10,000 ml for concentrated HCV virus and 10 grams HCV antigen per month, which is expected to bring WWBP considerable gross sales revenue each year and greatly strengthen the company’s R&D on anti-HCV drug screen system and HCV human vaccine. WWBP had successfully reached two merger agreements with pharmaceutical companies in China, both of which have scalable production and well-established sales network and the acquiring is expected to be finished before the end of 2005. The acquisitions will strengthen WWBP’s R&D abilities and production scale, as well as extend its marketing network throughout China and Southeast Asia. WWBP has been working closely with pharmaceutical research institutes, and has established sound connections with both central & local governments.
About GMP Certificate
GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that the products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.
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For more information, please contact: Worldwide Biotech and Pharmaceutical Company Ivy Liu Mobile: +86-29-8819-3339 Email: wwbp@worldwidebio.com
Worldwide Biotech & Pharmaceutical Company
CONTACT: Ivy Liu of Worldwide Biotech & Pharmaceutical Company,+86-29-8819-3339, or wwbp@worldwidebio.com
