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. According to reports from CNBC TV18, The Economic Times, and Business Standard, 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 Gujarat-based company stated that the reference market for the drug was valued at about $100 million for the 12 months ended March 2026, citing IQVIA data. As per latest reports, this final USFDA approval represents a meaningful addition to Alembic's US product portfolio, providing the company with an opportunity to participate in a sizeable segment of the US generics market.
The latest clearance adds to Alembic's portfolio in the US, its largest overseas market and a key contributor to international revenue. As reported by CNBC TV18, 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. The company has continued to strengthen its US formulations business in recent quarters, with revenue from the segment rising 11% year on year to ₹564 crore in the March quarter. As a vertically integrated research and development pharmaceutical company, Alembic continues to leverage its state-of-the-art manufacturing facilities, which are approved by regulatory authorities in several developed countries, to expand its global generic offerings.
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. According to CNBC TV18, its India branded formulations business grew 4% year-on-year to ₹568 crore. The ex-US generics business reported revenue of ₹369 crore during the quarter. The $100 million market size for Prucalopride Tablets represents a significant opportunity for Alembic to contribute meaningfully to its US revenue streams. Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults, belonging to a class of medicines known as serotonin-4 receptor agonists.
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. As reported by CNBC TV18, 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. The stock has shown positive momentum with recent gains, reflecting investor confidence in the company's regulatory milestones and growth prospects in the US generics market. The company launched six products in the US market and received four ANDA approvals in the March quarter, demonstrating continued expansion in its US operations.
