Competitive pricing and continued cost pressures have contributed to the need for many US biopharmaceutical companies to outsource manufacture of active pharmaceutical ingredients (API) and finished products from countries with lower costs for labor,material, and equipment. The main benefit of doing so is lower costs of manufacturing with quality standards comparable to those found in the United States. India and China now account for 80% of API production. But those countries have received media attention because of biopharmaceutical manufacturing issues. In particular, some drug manufacturers in India and China have failed to ensure that quality control procedures are followed after receiving initial record approval from the US Food and Drug Administration (FDA) and do not pay close attention to ongoing quality control.
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