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

Approximately, 80% of APIs used in the US and the European Union (EU) to manufacture finished pharmaceutical products come from Asia, with China and India accounting for much of the supply (2). An increasing number of manufacturing facilities for APIs have relocated to Asia. However, foreign manufacturers have concerns about producing certain proprietary drug products in Asia due to weak intellectual property protection laws. Chinese pharmaceutical companies are primarily oriented towards supplying their own domestic market and tend to place less emphasis on external good manufacturing practice...

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