Big Pharma companies are product license holders, not just manufacturers: purposeful fudging of responsibilities
...and have outsourced ALL manufacture!
Don't be fooled
Every time you hear a Big Pharma company referred to as a ‘manufacturer’, don't be fooled. They are responsible for everything, from cradle to grave in the lifecycle of the product they are licensed to sell. They have carefully branded themselves over the years as merely ‘manufacturers’ to distance themselves from their Regulatory responsibilities. The idea has been to disocciate themselves from ‘selling’, which has a much stronger assocation with overall culpability.
It has long bothered me that inside the industry, people refer to the pharma company as the manufacturer, while the wholesale distributor is the company dealing with pharmacies and doctors, having bought their products from the pharmaco’s. Once with the distributor, the pharma company wipes its hands of it. There is no further conversation between the two.
Other safety-critical sectors
Contrast this with other safety-critical sectors, such as the automotive industry. Agents and distributors sell to customers…