Quality and Safety of Asian Pharmaceutical Products—EU and US Regulatory Agency Activities and New Chinese GMP Regulations

摘要

The active pharmaceutical ingredients (API) and pharmaceutical product manufacturing industry is a complex global industry. While the United States and European pharmaceutical industries are experiencing little or no growth in this market segment, Asian producers are seeing high growth rates both from domestic demand and export sales. Countries in Asia are moving aggressively to supply ingredients to regulated markets such as US and Europe. The Chinese API producers generated estimated revenues of US$4.4 billion in 2005 and are projected to achieve sales of US$9.9 billion in 2010. Indian APi producers accounted for about US$2 billion in sales in 2005. These numbers are projected to larger in the next few years (1).