Senores Pharmaceuticals获得盐酸托吡酯25、50、100和200毫克片剂的ANDA-动脉网

Senores Pharmaceuticals acquires ANDA for Topiramate HCl 25, 50, 100 and 200 mg tablets

PHARMA FOCUS ASIA 等信源发布 2025-05-05 20:56

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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”)..

塞诺雷斯制药有限公司（“SPL”）通过其全资子公司美国塞诺雷斯制药公司（“SPI”），于今日签署协议，收购沃克哈特有限公司（“沃克哈特”）的美国食品药品监督管理局（USFDA）批准的简化新药申请（“ANDA”），涉及盐酸托吡酯25毫克、50毫克、100毫克和200毫克片剂（“托吡酯”）。

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.

托吡酯被指定用于治疗癫痫和偏头痛。根据IQVIA的数据，截至2024年12月，美国托吡酯片剂的市场规模约为1.1147亿美元（MAT 2024年12月）。

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.

该收购将通过SPL进行首次公开募股（“IPO”）所得款项来提供资金。这与红鲱鱼招股说明书中所述的IPO目的相符。

About Senores Pharmaceuticals Limited:

关于塞诺雷斯制药有限公司：

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..

塞诺雷斯制药有限公司（连同其子公司“塞诺雷斯”）是一家全球性的、以研发为导向的制药公司，致力于为美国、加拿大及其他受监管和新兴市场的各个治疗领域和剂型开发和生产多种类的医药产品。

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.

公司的现有产品组合包括61种ANDA和22种获准在美国分销的CMO/CDMO商业产品。Senores还从事经全球食品和药物管理机构认证的复杂仿制药的开发和生产，并为新兴市场提供仿制药，覆盖40多个国家。

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”)..

该公司目前已获得超过10个国家监管机构对其位于查特拉尔的制造工厂的批准，用于新兴市场，拥有260多个产品注册和530个产品申请。Senores还生产重症监护注射剂和活性药物成分（“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.

塞诺雷斯拥有2个制剂生产基地——一个位于美国亚特兰大，该基地通过了美国FDA认证，并符合DEA、TAA和BAA对管制物质及政府供应的要求；另一个位于印度艾哈迈达巴德的查特拉尔，通过了WHO-GMP认证，主要服务于新兴市场。该公司还在印度拥有2个原料药生产基地，均位于艾哈迈达巴德附近，一个在查特拉尔，另一个在纳罗达。

Senores has strong R&D capabilities to drive differentiated product portfolio across 3 R&D sites (1 in the USA and 2 in India)..

Senores在三个研发基地（一个在美国，两个在印度）拥有强大的研发能力，可以推动差异化的产品组合。

Safe Harbor Statement:

安全港声明：

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.

本文件中与未来状态、事件或情况有关的陈述，包括但不限于关于计划和目标、研发进展和结果、潜在项目特征、项目潜力及项目相关问题的目标日期的陈述，是基于估计和对未来事件对当前及发展中的情况的预期影响的前瞻性陈述。

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..

此类声明受诸多风险和不确定性的影响，不一定能够预测未来的结果。实际结果可能与前瞻性声明中预期的结果有重大差异。公司不承担更新前瞻性声明以反映实际结果、更改假设或其他因素的义务。

For more information, please contact:

更多信息，请联系：

Company: Senores Pharmaceuticals Limited CIN: L24290GJ2017PLC100263

公司：Senores制药有限公司 CIN：L24290GJ2017PLC100263

Mr. Deval Shah

德瓦尔·沙阿先生

Email: investors@senorespharma.com

电子邮件：investors@senorespharma.com

For updates and specific queries, please visit www.senorespharma.com

如需更新和具体查询，请访问 www.senorespharma.com

Investor Relations: Strategic Growth Advisor