Key Event and Quantitative Figures
On 28th July 2026, the company received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Prucalopride Tablets, 1 mg and 2 mg.
The approved product is therapeutically equivalent to the reference listed drug (RLD), Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA Inc.
The drug is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
The estimated market size for Prucalopride Tablets is US$ 100 million for the twelve months ending March 2026, according to IQVIA data.
Company Context and Cumulative Approvals
This approval increases Alembic's cumulative total of ANDA approvals from the USFDA to 245. This figure comprises 225 final approvals and 20 tentative approvals.
Regulatory References and Submission
The disclosure is made in compliance with listing regulations. The communication was digitally signed by Company Secretary Manisha Saraf on 28th July 2026 at 12:54:59 IST.
About the Company
The document reiterates that Alembic Pharmaceuticals Limited is a vertically integrated R&D pharmaceutical company headquartered in India, publicly listed, and has been operating since 1907. It manufactures and markets generic products globally with USFDA-approved facilities and has a field force of over 5500 for its branded generics business in India.