Digoxin API availability has been frequently and severely disrupted. Since 2014 there havbeen shortages of product due to high levels of impurities and an unreliable supply chain. In an effort to stabilise the supply chain, C2 Pharma has acquired the Digoxin API product portfolio of the Polish company, Nobilus Ent, self-developed and inherited from Roche/Galenus Mannheim.
Through the agreement, Luxembourg-based C2 Pharma, a phytochemical and chemical pharmaceutical manufacturing and distribution group, is the product owner, and Nobilus is a manufacturing partner and releasing entity for the API.
Parallel manufacturing to ensure redundancy is supported by long-term partner, Laurus Labs, an India-based API manufacturer with an impeccable track record.
To mitigate the expected future impact of those Digoxin API shortages, C2 Pharma has taken various actions, including this recent agreement, as well as setting up a fully independent supply chain for digitalis leaves and investing in a brand new, dedicated, state-of-the-art manufacturing facility with Laurus Labs in India.
“While this type of investment is unprecedented for such a niche product, we believe that it is the most responsible path to secure a quality, continuous supply of this complex and essential API,” CEO of C2 Pharma, Andrew Badrot said. “With existing impurity and supply issues, and as regulatory authorities progressively tighten specifications, this places C2 Pharma at the forefront of purification technology and process innovation for Digoxin API.”
Tech transfer has been completed and validated, and the Digoxin API is currently in production at the Nobilus Ent and Laurus Lab sites. Purchases can be made directly from C2 Pharma.