As about 50% of all clinical trials right now are dealing with APIs made up of nucleosides, peptides and carbohydrates, more major pharmaceutical companies will need these key intermediates in greater quantities, Subramaniam Arumugam, president and CEO of India-based CMO ArudaaVis, told Outsourcing-Pharma.com. And since not every manufacturer can make them, there will be more interest from large pharma companies and other intermediate purchasers, especially for low-cost CMOs in India and China, he said.
ArudaaVis’ current top partner is US-based Isis Pharmaceuticals, which Arumugam said has signed licensing deals with every top pharma company and is in high demand for more API intermediates. He noted that currently about 25 APIs in development have nucleotides that need the production of nucleosides and are in high demand, especially for cancer drugs.
“There’s an old saying that if you can make complex carbohydrates, you can make anything,” Arumugam said, noting purity challenges. He also noted that his company has only a few competitors in China that can match its low prices and expertise.
Indian, China API Exports to EU
As far as how India plans to deal with the new EU import laws for APIs from countries outside the region, Arumugam said he believes the government will come into compliance when the deadline arrives in July.
He added that most Indian API manufacturers and exporters are run by people, like himself, who have worked in the industry in the US and other Western countries before coming back to India and therefore understand the way the US FDA and EMA work and the importance of compliance.
A scientist at Albany Molecular Research who requested to remain anonymous also told Outsourcing-Pharma.com that the odds of the EU closing off API imports from some of the largest foreign manufacturers in India and China, and therefore causing widespread drug shortages, is slim.
He noted that shortages are already occurring because of how cheap APIs are.
China, which along with India produces 80% of the world’s APIs, is also likely to come into compliance with the EU requirements by July, Jack Lu, president and CEO of Chinese API intermediate manufacturer Aqbiopharma, told Outsourcing-Pharma.com.
He noted that China’s State Food and Drug Administration has increased its prominence over the last few years and is taken much more seriously now than in years past.