Piramal Pharma Solutions (PPS), a leading 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 subsidiary of Botanix Pharmaceuticals Limited, 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.
"This business partnership demonstrates our ability to deliver tailored, resilient solutions for organizations like Botanix," said Peter DeYoung, CEO, Piramal Global Pharma. "Our North American drug substance facilities are equipped with the expertise, advanced technology, and cutting-edge capabilities required to help derisk the Sofdra supply chain and ensure this breakthrough therapy reaches patients in need with consistency and efficiency."
This phased approach will enable PPS to support future supply needs for Sofpironium Bromide while offering the potential for dual-site production if additional capacity is required. By proactively supporting supply chain continuity, PPS can help improve the quality of life for patients living with primary axillary hyperhidrosis, underscoring and reinforcing its commitment to Patient Centricity.