Senores Pharmaceuticals acquires ANDA for Topiramate HCl 25, 50, 100 and 200 mg tablets
Senores Pharmaceuticals Limited (“SPL”), through its wholly-owned subsidiary Senores Pharmaceuticals, Inc., USA (“SPI”), has signed agreement today to acquire the USFDA-approved Abbreviated New Drug Application (“ANDA”) for Topiramate HCl 25, 50, 100 and 200 mg tablets (“Topiramate”) from Wockhardt Limited (“Wockhardt”).
Topiramate is indicated as a treatment of epilepsy and migraine. The market size of Topiramate Tablet in the USA was ~USD 111.47 Mn (MAT December 2024)1 as per IQVIA.
The acquisition will be funded through the Initial Public Offer (“IPO”) proceeds raised by SPL. This is in line with the Objects of the IPO stated in the Red Herring Prospectus.
About Senores Pharmaceuticals Limited:
Senores Pharmaceuticals Limited (together with its subsidiaries “Senores”) is a global, research-driven pharmaceutical company engaged in developing and manufacturing a wide range of pharmaceutical products predominantly for the US, Canada, and other regulated and emerging markets across various therapeutic areas and dosage forms.
The companies’ current portfolio includes 61 ANDA and 22 CMO/CDMO commercial products that are permitted for distribution in the USA. Senores is also engaged in the development and manufacturing of complex generics certified by global food and drugs authorities and delivers generic drugs for emerging markets catering to more than 40 countries. The company has currently approval from regulatory bodies of more than 10 countries for its manufacturing facility in Chhatral for emerging markets with over 260 product registrations and 530 product applications. Senores also manufactures critical care injectables and Active Pharmaceutical Ingredients (“API”).
Senores has 2 manufacturing facilities for formulations – one in Atlanta, US which is USFDA approved and DEA, TAA & BAA compliant for controlled substances and government supplies & other is in Chhatral, Ahmedabad, India approved by WHO-GMP to cater to emerging markets. The company also has 2 manufacturing facilities for API in India, both located around Ahmedabad, with one in Chhatral and the other in Naroda. Senores has strong R&D capabilities to drive differentiated product portfolio across 3 R&D sites (1 in the USA and 2 in India).
Safe Harbor Statement:
Statements in this document relating to future status, events, or circumstances, including but not limited to statements about plans and objectives, the progress and results of research and development, potential project characteristics, project potential and target dates for project related issues are forward-looking statements based on estimates and the anticipated effects of future events on current and developing circumstances. Such statements are subject to numerous risks and uncertainties and are not necessarily predictive of future results. Actual results may differ materially from those anticipated in the forward-looking statements. The company assumes no obligation to update forward-looking statements to reflect actual results changed assumptions or other factors.