Since its key plant in Halol was written up by the FDA following an inspection last year, Sun Pharmaceutical has gone all out to get on top of the agency's concerns. It has brought in outside consultants and invested in new systems and employee training. But it wasn't enough to ward off an FDA warning letter.
Temperature excursions along the supply chain for cold-chain pharma products often need to be investigated and that takes time, and time is money. That is one of the factors that has led AstraZeneca to move ahead with plans to shift the vast majority of its global shipments to sea freight from air freight.
Catalent is moving further and faster with its global expansion plans while building its softgel and nutritional product capacity. The contract manufacturer will move into Brazil with the acquisition of Relthy Laboratórios.
The product has been approved in Ireland, the Netherlands, Sweden and the U.K., but the company said Thursday that Swissmedic had turned down the drug.
It looks like a national track and trace system is going to be implemented in the U.S. sooner rather than later. Differences between what industry believes it is capable of handling and what regulators believe it must kept it out of the FDA reauthorization bill, but no one should think that put it into the deep freeze.
Federal authorities have taken down another player in the escalating counterfeit drug trade, this one for shipping foreign-made cold chain cancer drugs that arrived at a doctor's office as a "gooey mess."
Roche ($RHHBY) Diagnostics has reportedly begun a cold-chain-equipped direct flight each weekend from Indianapolis to Luxembourg. The move lets the drugmaker skip a stop in Chicago--European...