Alembic Pharmaceuticals Secures USFDA Final Approval for Prucalopride Tablets
Alembic Pharmaceuticals Limited announced that it has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) covering Prucalopride Tablets, 1 mg and 2 mg.The approved ANDA signifies that Alembic's product is therapeutically equivalent to Motegrity Tablets, 1 mg and 2 mg, manufactured by Takeda Pharmaceuticals USA Inc. Prucalopride tablets are indicated as a serotonin-4 receptor agonist used in the treatment of chronic idiopathic constipation (CIC) in adults.
The market potential for Prucalopride Tablets, 1 mg and 2 mg is estimated at US$ 100 million for twelve months ending March 2026, according to IQVIA. This approval adds to Alembic's substantial portfolio within the regulatory landscape.
Alembic has secured a cumulative total of 245 ANDA approvals from the USFDA, comprising 225 final approvals and 20 tentative approvals.
Key operational details regarding the product and corporate standing are summarized below:
| Metric | Details |
|---|---|
| Product | Prucalopride Tablets, 1 mg and 2 mg |
| Indication | Chronic idiopathic constipation (CIC) in adults |
| Therapeutic Equivalent | Motegrity Tablets, 1 mg and 2 mg of Takeda Pharmaceuticals USA Inc. |
| Market Size Estimate | US$ 100 million (for twelve months ending March 2026) |
| Cumulative ANDA Approvals | 245 (225 final; 20 tentative) |
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company established in 1907. Headquartered in India, the publicly listed company manufactures and markets generic pharmaceutical products globally. Alembic’s state of the art research and manufacturing facilities are approved by regulatory authorities in many developed countries, including the USFDA. The company is noted as a leader in branded generics in India, with its brands marketed through a field force exceeding 5500.
APLLTD Stock Price Movement
Shares of Alembic Pharmaceuticals Limited are edging higher to ₹824.90 as of 1:30 PM today, rallying by 1.28% in live trading. The stock sees strong interest from investors, with 33,151 shares traded while remaining within the intraday range of ₹810.35 and ₹825.50.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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