While pharmaceutical manufacturing facilities can age well, the care and attention aging facilities require can arise at inopportune moments, as was the case for Novo’s Wegovy launch. Even so, Catalent aims to make quick work of air handler replacement to get the new weight-loss drug back into production, despite typically long lead times, consultant says.
Efforts to remediate Catalent, Inc’s manufacturing site in Brussels, Belgium, to address US FDA inspectional observations and restore production of Novo Nordisk A/S’s just-launched Wegovy (semaglutide) reflect some of the challenges manufacturers face in keeping facilities fit as they age.
Catalent describes the Brussels plant as its flagship European syringe filling facility, with more than 70 years of biologics and...
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
