Today I believe that Besremi is manufactured exclusively in Taiwan. This seems like an elevated risk if China does indeed aggressively try to absorb the territory…or perhaps even if it isn’t aggressive.
I’m not trying to make a political statement but if China does take over the island for a variety of reasons there may be substantial long term risk to supplies. I would like to see them differentiate their manufacturing to a second location. Is anyone else aware of this risk and have concerns? It can take years to build a new facility.
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There is a risk that the supply chain for drugs manufactured in Taiwan would be disrupted if China moves to forcibly absorb Taiwan back into the People's Republic of China. Not sure we can do much about it. Hopefully, PharmaEssentia has contingency plans in place for that event. It seems highly unlikely they would share those plans, however.
Agreed. But given long time frame to manufacture elsewhere it would be challenging to imagine they could construct elsewhere either. Hopefully there is enough lead time that they could get a head start.
I just checked. Interesting lawsuit they have been embroiled in with the manufacturer. Unfortunately it looks like AOP is simply the European distributor, but all manufacturing happens in Taiwan. Given the complexity and cost of building the properly certified facility, which looks like it would take 2-5 years and with global demand (Besremi recently approved now in Brazil), and likely approval for ET soon, hopefully they have plans to open an additional facility elsewhere to diversify the singular supplier risk.
Used to teach international business at university level and can't quite understand the concern of supply from China. China is unlikely to stop a pharma exporting it's product. They might restrict import of a products if they don't like the source country but I can't think of an example of them restricting export by a company. The pandemic certainly showed the importance of having critical production from trusted partners and how globalized the world is.
It'll be interesting to watch how the pharmaceutical industry responds to the trade barriers being put up currently and where they may seek to expand production.
China is certainly willing to use its leverage whether for rare earth metals (ie, gallium) or other products in order to help secure its objectives. It has also restricted products even in medical supply channels before such as masks, gloves, gowns, and face shields which were subject to export restrictions or delays during the early years of the pandemic.
China is a major global supplier of APIs for antibiotics, antivirals, and many generic drugs.
During COVID-19 and again during geopolitical tensions (especially with India and the U.S.), China hinted at or threatened API export controls. While no formal ban was imposed on APIs at scale, logistical slowdowns and regulatory bottlenecks effectively constrained global access during critical periods.
More recently Chinese state media and some policymakers have suggested restricting medical supply exports as a form of economic retaliation, particularly around antibiotics, diabetes drugs, and even surgical consumables.
In addition, a potential military conflict or blockade involving Taiwan is also possible which could have a substantial negative impact on supply.
Having a singular manufacturing location is an inherent risk.
From what I have read online, Besremi is not compounded or formulated locally by Mayo Clinic. They are acting as the dispenser or coordinator for your Besremi supply, probably through their in-house specialty pharmacy or outpatient pharmacy services.
They then store snd ship the drug to you after it is supplied from a wholesaler or distributor (likely McKesson or another provider approved to handle Besremi).
They do not alter the formulation — the drug comes prefilled and ready for injection from the manufacturer.
It is, but in many ways I think restricting medication or even medical supplies in retaliation would be viewed very negatively. Restricting access to iPhone construction is quite different from life or death medications and related supplies.
Hopefully this does not come to fruition. It seems unlikely but does underscore the risk. No question it is a non zero risk. Why manufacturers ever build only 1 facility when shipping globally is beyond me. It’s cheaper but puts global supplies at risk for any event.
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