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Granules expands US generics pipeline with ADHD drug clearance
Granules India secured USFDA tentative approval for a generic ADHD drug, expanding its US portfolio and targeting a market valued at about $500 million.
Granules India has received tentative approval from the US Food and Drug Administration for a generic medication used in attention deficit hyperactivity disorder. The approval expands the company’s US portfolio to 195 ANDA approvals. The product targets an estimated $500 million market and final approval is expected after patent expiry, strengthening Granules’ export-focused pharmaceutical pipeline.