At a conference a few days ago I sat beside a former deputy commissioner of the Food and Drug Administration (FDA). We were in a small group that was discussing the need to help interested parties in Brazil, China, and India learn more about US drug regulatory affairs and compendial science. As best I could understand, the food and drug regulatory infrastructure in China and India appears to be much the same as it was in the US around the 1930s and 1940s. However, everyone agreed that China and India have some of the best medicinal chemists, pharmaceutical formulations engineers, and pharmacy plant manufacturing and pharmacokinetics specialists in the world.
During the conversation I learned that the vast majority of the world’s commercially available antibiotic products are manufactured in China and India. This information struck me as a shock! Until then, I had been under the impression that when the last antibiotic manufacturing plant closed in the US in 2004 and the industry moved off-shore, that the companies had gone to Puerto Rico and Europe. But China and India?
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