C2 Pharma, which concentrates on hard-to-make ingredients, has picked up a new supply of digoxin. The deal will give it two supplies of API for making the sometimes difficult-to-get drug.
The Luxembourg-based company has acquired the digoxin API product portfolio of Polish company Nobilus. The company said that through the agreement, C2 Pharma is the product owner and Nobilus is a manufacturing partner and releasing entity for the API. Terms of the deal were not disclosed.
“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,” C2 Pharma CEO Andrew Badrot said in a statement.
He pointed out that because of tighter regulatory oversight and the impurity and supply chain issues of some makers, supplies of digoxin APIs have been difficult for drugmakers to get since 2014.
C2 Pharma already has a long-term supply agreement and partnership with Indian API maker Laurus Labs. Last fall, the two validated the manufacturing process for two APIs, digoxin and digoxin micron, at a dedicated manufacturing facility at Laurus Labs’ site in Vizag, India. In 2016, C2 invested about $ 10 million to build the 1,800-square-meter facility. It says the annual production of that facility equals the entire global demand for digoxin.
The company says that with the parallel manufacturing by Nobilus and Laurus, C2 Pharma can ensure redundancy and constant supply.