Alembic Pharma gets USFDA approval for generic chronic constipation treatment tablets
- IBEF
- July 29, 2026
Alembic Pharmaceuticals Ltd. has strengthened its presence in the United States pharmaceutical market after receiving final approval from the US Food and Drug Administration (USFDA) for its generic prucalopride tablets in 1 mg and 2 mg strengths. The approval covers the company's Abbreviated New Drug Application (ANDA) for the treatment of chronic idiopathic constipation (CIC) in adults. The approved product has been recognised as therapeutically equivalent to Takeda Pharmaceuticals USA Inc.'s Motegrity tablets, enabling Alembic Pharmaceuticals to market a cost-effective generic alternative in the United States. The approval further expands the company's portfolio of USFDA-approved generic medicines and reinforces its strategy of strengthening its global formulations business through a diversified pipeline of complex and high-value pharmaceutical products.
According to the company, the reference market for prucalopride tablets has an estimated value of Rs. 940 crore (US$ 100 million), offering significant growth opportunities in the United States generics market. The latest approval reflects Alembic Pharmaceuticals continued focus on research and development, regulatory compliance and manufacturing excellence, supporting its long-term expansion in international markets. India's pharmaceutical industry continues to strengthen its global competitiveness through a robust pipeline of generic medicines, supported by high-quality manufacturing standards and regulatory approvals from leading international agencies. The approval is expected to enhance Alembic Pharmaceuticals' export portfolio, improve its presence in regulated markets and contribute to India's growing reputation as a reliable global supplier of affordable, high-quality pharmaceutical products while supporting the country's expanding pharmaceutical exports.
Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.
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