Alembic Pharma gains on USFDA nod for generic constipation drug targeting $100 million US market

Shares of Alembic Pharmaceuticals rose on Tuesday, July 28, after it received final approval from the US Food and Drug Administration (USFDA) to market Prucalopride Tablets in 1 mg and 2 mg strengths in the United States.

The approval covers the company's abbreviated new drug application (ANDA) for Prucalopride Tablets, which are therapeutically equivalent to Takeda Pharmaceuticals USA Inc's reference listed drug, Motegrity Tablets, the company said in an exchange filing.

Prucalopride belongs to a class of medicines known as serotonin-4 receptor agonists and is prescribed for adults with chronic idiopathic constipation, a condition characterised by persistent constipation without an identifiable underlying cause.

The Gujarat-based company said the reference market for the drug was valued at about $100 million for the 12 months ended March 2026, citing IQVIA data.

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US market remains a growth driver

The latest clearance adds to Alembic's portfolio in the US, its largest overseas market and a key contributor to international revenue.

With this approval, Alembic's cumulative tally of USFDA approvals has reached 245, including 225 final approvals and 20 tentative approvals. Final approvals allow companies to commercialise generic medicines in the US, subject to patent and market conditions.

Alembic has continued to strengthen its US formulations business in recent quarters. In the March quarter, revenue from the segment rose 11% year on year to ₹564 crore, while the company launched six products in the US market and received four ANDA approvals. The ex-US generics business reported revenue of ₹369 crore during the quarter.

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For the quarter ended March 2026, the drugmaker reported a 29% year-on-year increase in consolidated net profit to ₹202 crore, while revenue rose 4.4% to ₹1,848 crore. Its India branded formulations business grew 4% year-on-year to ₹568 crore.

Shares of Alembic Pharmaceuticals rose 1.66% to the day's high, but pared some of the gains and were trading 0.74% higher at ₹820.45 as of 3.22 pm. The stock has gained 4.3% over the past month and 7.4% in the last six months, although it remains down 2% year to date and 18% over the past year.