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Hence an approval in the next one-and-a-half to two years seems unlikely." Chereddi adds, "Hengrui's product is just starting Phase 3 in China, and Innovent's product has approval from the Chinese FDA, but hasn't been filed in India." His conclusion: "Indian generic manufacturers face a limited but real opportunity—not an open market." Shah frames it as a "timing risk, not an inevitability", and flags three gating factors beyond trial requirements: Regulatory scrutiny of novel oral delivery systems, bioavailability concerns specific to Indian populations and intellectual property protection on oral peptide platforms that limits immediate generic replication
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