Novo Nordisk A/S NVO has encountered manufacturing challenges and drug shortages for its diabetes and weight reduction medicine on account of unprecedented demand for Wegvoy and Ozempic.
To handle the scarcity, Novo Nordisk agreed to amass three fill-finish websites from Novo Holdings A/S in reference to a transaction the place Monday, Novo Holdings agreed to amass Catalent Inc CTLT.
Novo Nordisk will purchase the three manufacturing websites for an upfront fee of $11 billion.
The three manufacturing websites specialize within the sterile filling of medicine and are positioned in Anagni (Italy), Brussels (Belgium), and Bloomington (Indiana, US).
The three websites make use of greater than 3,000 individuals and have ongoing collaborations with Novo Nordisk.
The mum or dad firm of Novo Nordisk agreed to pay $63.50 Per Share in Money in an all-cash transaction that values Catalent at $16.5 billion on an enterprise worth foundation.
Notably, the FDA uncovered high quality management lapses throughout an inspection in November, exposing numerous considerations, together with the presence of a “pest” on the manufacturing line, as detailed within the inspection report.
The FDA inspection from October 31 to November 15 highlighted 5 distinct observations, Reuters reported.
Catalent confronted criticism for failing to analyze unexplained discrepancies in sure product batches totally.
The FDA’s report, obtained via a Freedom of Info Act request, revealed roughly 194 deviations recorded between October 31, 2021, and October 31, 2023, with Catalent unable to establish the basis reason for 171 incidents.
The FDA’s findings included inadequacies in written procedures designed to forestall microbial contamination of sterile merchandise. Cases of sterile-safety breaches, operators’ naked face/pores and skin and robes touching, obvious residues, and the invention of ink on the manufacturing line raised considerations about Catalent’s adherence to high quality management requirements.
FDA inspectors visited the Brussels-based plant in October 2021 and August 2022 to evaluate its manufacturing regulatory compliance.
The investigation revealed that workers on the Catalent manufacturing facility, which handles Wegovy’s pen-filling course of, didn’t constantly perform required high quality checks.
Worth Motion: CTLT shares are buying and selling decrease by 0.56% at $58.16 on the final test Wednesday.
Photograph By Natalia Varlei On Shutterstock