To supply the Dane: Novo expects First API batch in 2020

By Gareth Macdonald contact

- Last updated on GMT

Novo opts to build US API capacity for semaglutide rather than outsource
Novo opts to build US API capacity for semaglutide rather than outsource
Novo Nordisk has confirmed it will build an API plant in the US, telling this publication a desire to have manufacturing capacity in the key market for its oral diabetes candidate, semaglutide, drove the decision.

The drugmaker announced​ its plans to invest $2bn to build both the plant in Clayton, North Carolina and a finished product site in Måløv, Denmark today, confirming a plan hinted at by CEO Lars Rebien Sørensen in an interview with Bloomberg​ last week.

Spokeswoman Katrine Rud von Sperling told us building the active pharmaceutical ingredient (API) plant in the US makes sense from both a financial and economic perspective.

We decided to place the new API facilities in the US for strategic reasons. The US is by far our largest market and there are many logistical and economic advantages of having a larger part of our manufacturing in our main market.

She added that: “After a thorough evaluation of multiple sites and an extensive vetting process, Clayton ended up being our preferred location. We already have a large and very professional organisation there and an excellent collaboration with city, local and state leadership.

US focus

Novo’s exiting site in Clayton is responsible for the formulation, filling and packaging of its diabetes care products. It also produces the firm’s Felxpen and FlexTouch prefilled insulin devices for the US market.

The new facility – which is due to be operational by 2020 according to Sperling – will focus solely on producing finished API from raw material shipped to the site. At present all the drug actives Novo uses are made at its facility in Kalundborg, Denmark.

Sperling also told us the decision to build in-house capacity rather than outsource is testament to Novo’s expertise in the production of protein, which she said it a “core capability​.”

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