Senores Pharmaceuticals Gains Philippine FDA Approval for 10 Products
Filing Summary
Senores Pharmaceuticals Limited has received marketing authorizations from the Philippine Food and Drug Administration for 10 products. These products span therapeutic areas such as cardiovascular, CNS, and pain management. The market value for these drugs in the Philippines is estimated at USD 23 million. This development aligns with Senores Pharmaceuticals’ strategy to expand its presence in Southeast Asia. The company operates two manufacturing facilities for formulations and two for APIs, with approvals from multiple regulatory bodies. Senores Pharmaceuticals is focused on enhancing access to affordable healthcare in emerging markets.
Senores Pharmaceuticals Limited has announced the receipt of marketing authorizations from the Philippine Food and Drug Administration for 10 products. These products cover therapeutic areas including cardiovascular, CNS, and pain management. The approvals are part of the company’s strategy to expand its footprint in Southeast Asia.
The market size for these products in the Philippines is valued at approximately USD 23 million. This valuation highlights the potential for Senores Pharmaceuticals to increase its market presence in the region. The company has not disclosed specific financial terms or payment structures related to these approvals.
The approved products will enable Senores Pharmaceuticals to serve the Philippine market more effectively. The company focuses on developing and manufacturing a wide range of pharmaceutical products, primarily for the US, Canada, and other regulated and emerging markets. Senores Pharmaceuticals has a portfolio that includes 32 own ANDA and 32 CMO/CDMO commercial products for distribution in the USA.
Senores Pharmaceuticals operates two manufacturing facilities for formulations, one in Atlanta, US, which is USFDA approved and DEA/BAA compliant, and another in Chhatral, Ahmedabad, India, approved by WHO-GMP. Additionally, the company has two API manufacturing facilities in India, located in Chhatral and Naroda. These facilities have received approvals from regulatory bodies in over 10 countries, supporting the company’s operations in emerging markets.
The timeline for the implementation of these marketing authorizations has not been specified in the filing. However, the approvals mark a significant step in the company’s regional expansion strategy. The company aims to leverage its manufacturing capabilities and regulatory endorsements to enhance its presence in the Asia-Pacific region.
Senores Pharmaceuticals Limited is a global, research-driven pharmaceutical company engaged in developing and manufacturing pharmaceutical products. The company focuses on complex generics and critical care injectables, catering to more than 40 countries. Senores Pharmaceuticals is committed to delivering high-quality, affordable treatments and expanding access to healthcare in emerging markets.