Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration for its generic Prucalopride Tablets in 1 mg and 2 mg strengths.
The medicine is approved for treating chronic idiopathic constipation in adults and is therapeutically equivalent to Takeda Pharmaceuticals USA’s Motegrity tablets. The approval allows Alembic to introduce a more affordable generic alternative in the United States market.
The US market for Prucalopride Tablets is estimated at around ₹940 crore, or US$100 million, offering a significant commercial opportunity for the company.
The approval expands Alembic’s portfolio of USFDA-approved medicines and strengthens its presence in regulated international markets. It also highlights the growing role of Indian pharmaceutical companies in supplying affordable, quality-assured generic medicines worldwide.
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