Alembic Pharmaceuticals has received final approval from the United States Food and Drug Administration (USFDA) for Prucalopride Tablets in 1 mg and 2 mg strengths. The clearance allows the company to launch a generic version of Takeda Pharmaceuticals USA Inc.’s reference listed drug, Motegrity, targeting chronic idiopathic constipation in adults. This regulatory milestone expands Alembic’s footprint in the US generics market, where the product holds an estimated market size of $100 million for the twelve months ending March 2026, according to IQVIA data.

Approval Details

The approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to the reference listed drug. The following table summarizes the key regulatory and market parameters:

Strategic Significance

The final USFDA approval for Prucalopride Tablets represents a meaningful addition to Alembic Pharmaceuticals' US product portfolio. With expected US sales of $100 million for the reference market, this approval provides the company with an opportunity to participate in a sizeable segment of the US generics market. The clearance underscores the company's continued focus on building its regulated market pipeline through USFDA-approved products.

Portfolio Growth

This latest approval brings Alembic’s cumulative total of USFDA ANDA approvals to 245. The portfolio comprises 225 final approvals and 20 tentative approvals. As a vertically integrated research and development pharmaceutical company, Alembic continues to leverage its state-of-the-art manufacturing facilities, which are approved by regulatory authorities in several developed countries, to expand its global generic offerings.

Alembic Pharmaceuticals Limited will host a post-results conference call on Tuesday, August 4, 2026, at 5:30 PM IST to discuss its Q1 FY27 unaudited financial results. The session is restricted to analysts and institutional investors, providing a platform for management to address queries regarding the latest quarterly performance. This disclosure was filed with the Bombay Stock Exchange and the National Stock Exchange of India Ltd. on July 27, 2026.

Conference Call Details

The company's senior management team will lead the discussion. Investors and analysts have two options to join the call. The first option involves registering through the Diamond Pass portal, which provides dial-in numbers, passcodes, and pins directly to the registered email address. This method allows participants to connect without waiting for an operator. The second option involves direct dial-in using the universal access numbers or toll-free lines available for India, the USA, the UK, Singapore, and Hong Kong.

Dial-In Information

For further assistance, Isha Lamba can be contacted at +91 22-66951652 or via email at isha.lamba@alembic.co.in . The company's Chief Financial Officer, G. Krishnan, signed the disclosure letter dated July 27, 2026.