Piramal Pharma Solutions has entered into a manufacturing and supply partnership with Botanix Pharmaceuticals to support the development and future commercial supply of Sofpironium Bromide, the active pharmaceutical ingredient used in Sofdra®, a treatment approved for primary axillary hyperhidrosis. Under the agreement, Piramal Pharma Solutions will begin process development and validation activities for the API at its Riverview, Michigan facility in the United States.
Following regulatory approval of the Riverview site, the companies will evaluate the possibility of expanding manufacturing validation activities to Piramal’s Aurora facility in Canada. The proposed dual-site approach is expected to provide Botanix with greater operational flexibility and long-term supply chain security through a geographically diversified sourcing model.
The collaboration is designed to support future commercial demand while reducing potential supply disruptions through manufacturing redundancy and integrated production capabilities across North America. Piramal Pharma Solutions stated that both facilities have undergone significant investments in advanced manufacturing infrastructure, process systems and technology integration to support complex pharmaceutical development programs efficiently and at scale.
The Riverview and Aurora operations collectively provide expertise across research, development, scale-up and commercial manufacturing for pharmaceutical drug substances. By maintaining manufacturing capabilities at two strategic locations, the company expects to offer Botanix additional flexibility in scheduling, production continuity and risk mitigation in the event of geopolitical or operational disruptions.
Peter DeYoung, Chief Executive Officer of Piramal Global Pharma, said the partnership reflects the company’s ability to deliver customized and resilient manufacturing solutions for pharmaceutical innovators. He noted that the combination of technical expertise, advanced manufacturing technology and integrated North American operations would help strengthen the Sofdra® supply chain while ensuring reliable access for patients.
The dual-site strategy is also expected to improve cost efficiencies and reduce overall cost of goods sold for Botanix while supporting future capacity expansion if demand increases globally. Piramal Pharma Solutions added that the arrangement aligns with its patient-centric approach by helping maintain uninterrupted access to therapies for individuals affected by primary axillary hyperhidrosis, a condition characterized by excessive underarm sweating.
Piramal Pharma Solutions operates a globally integrated network of development and manufacturing facilities across North America, Europe, and Asia. The company offers end-to-end services across the pharmaceutical lifecycle, including drug discovery, process development, clinical trial supplies, commercial manufacturing of APIs, sterile fill-finish solutions, peptide manufacturing, biologics, gene therapies, and highly potent drug products. Piramal Pharma Limited currently operates through 17 global development and manufacturing facilities and serves customers across more than 100 countries through its pharmaceutical manufacturing and healthcare businesses.
