PharmaTher's Ketamine ANDA Gains U.S. Demand Boost with CNPV Deal
PharmaTher has gained a significant boost with CNPV's support, creating a strong U.S. demand for its recently sold ketamine-based ANDA. This deal, potentially worth over US$25 million, reduces risks and preserves long-term growth prospects.
CNPV's involvement is expected to accelerate PharmaTher's capital-light ketamine strategy. It aligns with the company's plan to submit FDA-aligned CMC and conduct focused clinical 'bridges' suitable for 505(b)(2). Ecosystem signals, such as public announcements and resolved shortages, indicate sustained momentum for ketamine.
FDA's prioritization of ketamine has sparked interest among hospitals, GPOs, and public buyers, amplifying demand for reliable U.S. sources. CNPV's streamlined review process, with a decision window of around 1-2 months, reduces regulatory friction, enabling faster conversion of supply into sales. PharmaTher's partner in sterile injectables brings valuable manufacturing and U.S. regulatory/commercial capabilities, allowing economic participation without substantial investment.
CNPV fuels PharmaTher's momentum, positioning it at the forefront of the ketamine market. The deal reduces execution risk, preserves significant long-term upside, and aligns with the company's ketamine-based 505(b)(2) strategy. With FDA's prioritization and CNPV's streamlined process, PharmaTher is well-placed to capitalize on the growing demand for ketamine in the U.S.