Piramal and Botanix to support API supply for North America

Piramal Pharma Solutions, a contract development and manufacturing organization (CDMO) headquartered in Mumbai, India, has entered a manufacturing and supply agreement with Botanix SB, a subsidiary of Australia-based Botanix Pharmaceuticals, to support development and commercial supply of the active pharmaceutical ingredient in Sofdra, an FDA-approved treatment for primary axillary hyperhidrosis.

Under the agreement, Piramal will initiate development and validation services for sofpironium bromide at its Riverview, Michigan facility, according to the announcement. Following successful regulatory approval at Riverview, the companies will consider validating the process at Piramal’s Aurora, Canada facility, which the company said would give Botanix the option to use Piramal as a dual-source commercial API supplier to support long-term supply chain flexibility.

Peter DeYoung, CEO of Piramal Global Pharma, said in a statement that the partnership demonstrates the company’s ability to deliver resilient solutions and that its North American drug substance facilities are equipped to help derisk the Sofdra supply chain.

The announcement follows Piramal’s launch last week of a new payload-linker development and manufacturing suite at its Riverview facility, part of a broader $90 million U.S. manufacturing expansion that also includes enhanced commercial-scale capabilities at its sterile injectables facility in Lexington, Kentucky.