Alembic Pharmaceuticals Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Prucalopride Tablets in strengths of 1 mg and 2 mg. The approval enables the company to market the generic version of Motegrity tablets, developed by Takeda Pharmaceuticals USA Inc, in the United States.
Prucalopride is a serotonin-4 receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adults. The medication is prescribed to improve bowel movement frequency and help manage chronic constipation in patients where no underlying medical cause has been identified. The product will be marketed in accordance with the approved prescribing information issued by the USFDA.
According to IQVIA data for the 12-month period ending March 2026, the Prucalopride tablet market in the United States is estimated at US$100 million, presenting a significant opportunity for Alembic to expand its presence in the gastrointestinal therapy segment.The latest approval further strengthens Alembic’s product portfolio in the highly regulated US pharmaceutical market. With this addition, the company has secured a cumulative 245 ANDA approvals from the USFDA, comprising 225 final approvals and 20 tentative approvals. The milestone reflects Alembic’s continued focus on developing and commercialising high-quality generic medicines across multiple therapeutic categories.
Alembic has consistently invested in research and development, advanced manufacturing technologies and regulatory compliance to support the launch of complex and value-added generic products in international markets. The company’s expanding portfolio of USFDA-approved products reinforces its commitment to meeting the growing demand for affordable medicines while maintaining global quality standards.
Established in 1907, Alembic Pharmaceuticals Limited is one of India’s leading research-driven pharmaceutical companies with a strong presence in both domestic and international markets. The company follows a vertically integrated business model encompassing research, product development, manufacturing and marketing of generic pharmaceutical formulations and active pharmaceutical ingredients.
Headquartered in Vadodara, Gujarat, Alembic operates modern research and manufacturing facilities that have received approvals from several leading global regulatory authorities, including the USFDA. These facilities support the company’s growing portfolio of products supplied to healthcare markets around the world. In India, Alembic is among the leading branded generic pharmaceutical companies, supported by a nationwide field force of more than 5,500 professionals. Its portfolio covers multiple therapeutic areas and enjoys strong recognition among healthcare professionals and patients.
