Piramal Pharma Solutions inks partnership with Botanix to support drug substance development

Piramal Pharma Solutions (PPS), a leading global Contract Development and Manufacturing Organization (CDMO) and part of Mumbai-based Piramal Pharma, has entered a manufacturing and supply arrangement with Botanix SB Inc., a subsidiary of US-based Botanix Pharmaceuticals.

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.

With decades of combined experience, the Riverview and Aurora facilities offer exceptional proficiency in drug substance development and manufacturing, spanning R&D through commercialisation. Recent investments have provided both facilities with the advanced equipment and unified systems required to execute this programme, reinforcing the strengths of their geographic proximity and integration expertise while enhancing their ability to offer cost-efficient solutions.