Senores Pharma Acquires FDA-Approved Topiramate ANDA from Wockhardt

Topiramate hydrochloride tablets from Wockhard Ltd have been approved by Abbreviated New Drug Application, the achievement of the US FDA, announced by Ahmedabad-based Senores Pharmaceuticals Limited. This agreement includes all four dosage powers of 25 mg, 50 mg, 100 mg, and 200 mg that are used in the treatment of epilepsy and migraines.

While the financial information of the agreement remains unrevealed, the acquisition will be funded through profits raised by Senores Pharma’s recent IPO, supporting the objectives drawn in its Red Herring Catalog. The IPO raised nearly Rs. 580 crore, covering a fresh issue of Rs. 500 crore and an offer for sale worth Rs. 82.11 crore.

According to IQVIA, Topiramate holds a substantial existence in the U.S. pharmaceutical market, with a market size of approximately US $111.47 million as of December 2024.

This acquisition enhances Senores Pharma’s strong U.S. portfolio, which currently consists of 61 approved ANDAs and 22 commercial CMO/CDMO products spread across the country. The company has also added regulatory approvals in over 10 international markets for its manufacturing facility located in Chhatral, near Ahmedabad, with more than 260 registered products and 530 product applications globally.

Senores operate two formulation manufacturing plants, one in Atlanta, USA, and another in Chhatral, India. The two API production sites were added to Ahmedabad. The research and development abilities are supported by three research centers, counting one in the United States.

This recent gain marks a planned step in Senores Pharma’s goal to enlarge its footprint in regulated markets, mainly in the U.S., while continuing to strengthen its offerings across strategic therapeutic areas.