- Piramal Pharma Solutions has entered a manufacturing and supply arrangement with Botanix SB for Sofpironium Bromide, the API used in Sofdra®.
- The agreement includes development and validation work at PPS’s Michigan facility, with potential expansion to a second manufacturing site in Canada.
Piramal Pharma Solutions (PPS) has entered a manufacturing and supply arrangement with Botanix SB Inc., a subsidiary of Botanix Pharmaceuticals, to support production of Sofpironium Bromide, the active pharmaceutical ingredient (API) in Sofdra®.
Under the agreement, PPS will begin development and validation services for the API at its Riverview, Michigan facility. The companies stated that, following regulatory approval at the site, they may also validate the process at PPS’s Aurora, Canada facility as part of a potential dual-site manufacturing strategy.
According to PPS, the approach is intended to provide supply chain flexibility, manufacturing redundancy, and continuity of supply. The company stated that the Riverview and Aurora facilities have recently received investments in equipment and integrated systems to support drug substance development and commercial manufacturing activities.
“This business partnership demonstrates our ability to deliver tailored, resilient solutions for organizations like Botanix. 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.”
Peter DeYoung, CEO, Piramal Global Pharma
PPS said the phased strategy could support future Sofpironium Bromide supply requirements and potentially reduce cost of goods sold for Botanix. The agreement further expands the company’s CDMO and contract manufacturing activities across North America while supporting supply continuity for therapies targeting primary axillary hyperhidrosis.
