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The faster pace of approvals by the US Food and Drug Administration (USFDA) is leading to a steep fall, not just in the price of generic drugs but also of limited competition products of Indian pharma companies in the world’s largest health care market.
While the products, be it niche or under exclusivity, bring a windfall for pharma companies in the initial period, sales thereafter have tended to fall at a much faster clip given higher competition. The trend led by channel consolidation, USFDA’s push towards faster abbreviated new drug approvals (ANDAs) under the general Drug User Fee Act and demands
