Acquisition of niche API portfolio ensures quality and continuous supply
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A fully redundant supply of digoxin API from C2 Pharma will be available via two CMO manufacturing sources at Nobilus in Poland and Laurus Labs in India.
C2 Pharma has acquired the digoxin API product portfolio of Polish company, Nobilus Ent, self-developed and inherited from Roche/Galenus Mannheim. Through the agreement, C2 Pharma 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.
Since 2014, digoxin API availability has been frequently and severely disrupted causing shortages of product due to high levels of impurities and an unreliable supply chain. 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,” said CEO of C2 Pharma, Andrew Badrot. “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.
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