Piramal Pharma Solutions, Botanix Partner to Support Drug Substance Development

Piramal Pharma Solutions (PPS), a global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd., has entered a manufacturing and supply arrangement with Botanix SB Inc., a commercial dermatology company.

Under this arrangement, PPS will initiate development and validation services for Sofpironium Bromide, the active pharmaceutical ingredient (API) in Sofdra, at its Riverview, Michigan facility. Following successful regulatory approval at Riverview, PPS and Botanix will consider validating the process at PPS’s Aurora, Canada facility. This potential twin-site strategy would give Botanix the option to use PPS as a dual-source commercial API supplier, enhancing its long-term supply chain flexibility and security.

By maintaining the option for development and validation at both sites, PPS can offer partners redundancy, supply chain continuity, and scheduling flexibility. If geopolitical issues arise, PPS can seamlessly shift production between facilities, ensuring ongoing supply for Botanix and its patients. This proactive approach enables PPS’s partners to remain agile and resilient amid global uncertainty, with robust coverage across the U.S. and the rest of the world.

These twin-site capabilities also offer financial benefits, enabling PPS’s partners to better balance quality and time. By derisking the Sofdra supply chain, PPS is expected to provide Botanix a significant reduction in cost of goods sold.

“This business partnership demonstrates our ability to deliver tailored, resilient solutions for organizations like Botanix,” said Peter DeYoung, CEO, Piramal Global Pharma.

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Piramal Pharma Solutions recently unveiled a new payload-linker development and manufacturing suite at its Riverview, Michigan drug substance facility.