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As on : 28-Jul-2026
Alembic Pharmaceuticals receives USFDA approval for Prucalopride Tablets
 <P>Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food &amp; Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Prucalopride Tablets, 1 mg and 2 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA Inc. Prucalopride tablets are serotonin-4 receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adults.&nbsp;</P> <P>Prucalopride Tablets, 1 mg and 2 mg, have an estimated market size of US$ 100 million for twelve months ending March 2026 according to IQVIA.</P>

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