Explore the complexities of Chinese generic drug production, from its 80% API market dominance to critical quality gaps and the global push for supply chain diversification.
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Explore how the FDA monitors foreign generic drug plants, the shift to unannounced inspections, and the impact of CGMP standards on global pharmaceutical safety.
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Patent Term Restoration recovers time lost during FDA regulatory review. Learn how the Hatch-Waxman Act extends exclusivity, calculation rules, and strategic implications for pharma.
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