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In a remarkable stride for innovation and speed, Dr. Reddy’s Laboratories has received Tentative Approval for Generic Lumateperone capsules a milestone that marks a new benchmark in small molecule development. Filed on NCE-1, this submission reflects our commitment to strategic excellence and scientific precision. Lumateperone completed DMF adequacy and received Tentative Approval in just 20 months, one of the fastest timelines in recent years for a small molecule. This is more than just a regulatory milestone. It’s a testament to our agility, collaboration, and relentless pursuit of quality. Congratulations to everyone who made this possible.
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