Alembic Pharmaceuticals Ltd. has received final approval from the U.S. Food and Drug Administration (USFDA) for its generic prucalopride tablets in 1 mg and 2 mg strengths, further strengthening its presence in the U.S. pharmaceutical market.
The approval covers the company’s Abbreviated New Drug Application (ANDA) for the treatment of chronic idiopathic constipation (CIC) in adults. Alembic’s generic product has been deemed therapeutically equivalent to Takeda Pharmaceuticals USA Inc.’s Motegrity tablets, allowing the company to market a more affordable generic alternative in the United States.
The latest approval expands Alembic’s portfolio of USFDA-approved generic medicines and aligns with its strategy of growing its global formulations business through a diversified pipeline of complex and high-value pharmaceutical products.
According to the company, the U.S. market for prucalopride tablets is valued at approximately Rs. 940 crore (US$100 million), presenting significant growth opportunities in the highly competitive generics segment.
The approval also highlights Alembic Pharmaceuticals’ continued focus on research and development, regulatory compliance, and manufacturing excellence, reinforcing its long-term strategy to expand in regulated international markets.
India’s pharmaceutical industry continues to strengthen its global standing through a robust pipeline of high-quality generic medicines supported by world-class manufacturing standards and approvals from leading regulatory agencies. The USFDA clearance is expected to enhance Alembic’s export portfolio, strengthen its presence in regulated markets, and further reinforce India’s reputation as a reliable global supplier of affordable, high-quality pharmaceutical products while contributing to the country’s growing pharmaceutical exports.