CPHI Frankfurt 2025: The Current API Market

APIs are a prominent and important part of a drug product. Pharmaceutical companies often source these materials from global API manufacturers, and qualifying these suppliers is integral to good manufacturing practices and regulations. A secure supply chain for these materials is also imperative.

With a variety of potential disruptions that may result from the current geopolitical climate, Dr. Weite Oldenziel, CEO of Ofichem, gives his perspective on why API suppliers should be qualified and how the current API market is handling the political landscape.

“Changes [in the API market] are always present, and we have to conclude that by far the majority of the APIs [are] being produced in Southeast Asia and predominantly in the countries India and China,” Oldenziel says. “There is a lot of talk about, say, reshoring, onshoring, near shoring. It is very difficult to substantiate this, to which extent this is happening. It is also very important to realize that no two APIs are alike. A low-volume, high-priced, proprietary API is completely something different than a large-volume, low-priced, generic API.”

“So, how is the sector reimagining supply chains? In general, I would say not that much,” Oldenziel says. “Things in the pharmaceutical supply chain are moving relatively slow. It is quite a conservative market where strict compliance with rules and regulations is very important. So, processes just move slow, and they can't anticipate on incidents in the world markets. Only when an incident has a more structural character… you will see that supply chains are affected.”

Ofichem will be exhibiting at CPHI Frankfurt 2025, which is happening from Oct. 28–30 in Frankfurt, Germany. You are welcome to visit their stand, number 11.0A89, zone API.

Click on the link about to watch the interview.

About the speaker

Dr. Weite Oldenziel is CEO of Ofichem, a fully integrated pharmaceutical company, both in drug substance and in drug product. He is a pharmacist and has a PhD in neurochemistry.

Transcript

Editor's note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

My name is Weite Oldenziel from a background. I'm a pharmacist and did a PhD in neurochemistry, and since almost 20 years, I'm now the CEO of the Ofichem Group, which is a fully integrated pharmaceutical company, both in drug substance and in drug product number two, sorry, yeah, very important for pharma manufacturers, of course, is the technical part. So the API supplier should fulfill all kinds of regulation. That's a no brainer. You things like GMP, things like an API registration, things like an asmf or a CEP. That's crystal clear. However, also very important, which is actually not part of the official supplier qualification, is that an API supplier also should be proactive. Should be supporting the pharma manufacturer should help and guide them, because only when they work together, the pharma manufacturer and the API supplier, they can bring the medicine to the market.

So yeah, what does the current API market look like? Of course, changes are always present, and we have to conclude that by far the majority of the APIs being produced in Southeast Asia and predominantly in the countries India and China. There are a lot of talks about, say, reshoring, on shoring, near shoring. It's very difficult to substantiate this, to which extent this is happening. It's also very important to realize that one API is not the other one. A low volume, high priced, proprietary API is completely something different as a large volume, low priced, generic API. So maybe not from a technical point of view, this API is different, but certainly from a commercial point of view.

So how is the sector re imaging, supply chains? This is quite a difficult question. In general, I would say not that much overall, and that has to do with the fact that things in the pharmaceutical supply chain are moving relatively slow. It's quite a conservative market where compliance and to remain in compliance is very important. So processes just move slow and they can't anticipate on incidents in the world markets, so only when an incident gets more like a structural character, yeah, then you really can see that supply chains are affected. What, for example, you've seen a few years ago when development. Proprietary APIs. More was reshored back to Europe and US. Or what you see now is at the Trump administration that there are more initiatives for maybe reshoring to US soil. But at this moment, that's not very tangible yet.

I'm very much looking forward to the cphi with enthusiasm. It's always very nice to reconnect with old friends and with acquaintances and to talk about the pharmaceutical world, which is our work, and which I'm really passionate about.