Chinese peptide company China's role in global generic drug supply chain

To explore the potential impact of the new coronavirus on the generic drug market, particularly the impact of isolation and travel bans on the supply chain, GLG Gree recently met with Steven Lynn, the former head of the manufacturing and product quality office of the U.S.

Food and Drug Administration’s Center for drug evaluation and research compliance office. Mr. Lynn has also served as global head of group compliance and audit at Novartis and vice president of global quality compliance for mylan. Here is his opinion (edited).

GLG: the first thing we want to know is, how many APIs (active pharmaceutical ingredients) in the world come from China?

Steven: it’s a trillion dollar issue. According to the U.S. Food and Drug Administration (FDA), about 60% or 70% are from China, but since these data are not up-to-date, it is difficult to know the current actual percentage. Both drug manufacturers and suppliers must register with the FDA, but the FDA does not know the exact current production capacity of production bases around the world. They certainly want to get the data, but under the current law, they can only apply for it.

However, it is certain that a large part of the world’s API comes from China, whether it is new drugs, generic drugs or biotechnological APIs. Most of these APIs are exported to India, where they are made into finished products. However, there is also a large number of API production in the European Union, as well as in the United States.

GLG: what has changed recently?

Steven: in terms of brand drugs and generic drugs, the production of API in China is likely to decline slightly. I say this because many companies are focusing on drug compliance issues in India and China and trying to solve them. But at the same time, these companies are unable to find other API suppliers, so many of them are at a loss and have to make the best use of the resources on hand – which is why I think a large proportion of APIs will still come from China.

This is also the case for finished products produced in India. Many companies want to move out of India, but often they can’t because of financial problems. The cost of manufacturing in India or China is much lower than in the European Union or the United States, so they are at a loss.

GLG: what if we increase API production in the United States? Is this feasible?

Steven Lynn: I don’t have statistics on the current production in the United States, but I guess it will increase about 10% of the total production. The biggest problem is capacity. Is the U.S. production base capable of increasing production? Do they have spare production lines to put into production?

There is also a question of whether they have been approved by the FDA or the European Drug Administration (EMA) to produce at the base. If it is not approved, it will take several months to accumulate the data required for the application. Then, approval may take another few months. As a result, capacity and regulatory approval are the biggest barriers to the production of APIs outside China.

GLG: are generic drug manufacturers producing more in China than brand drug manufacturers?

Steven Lynn: Generally speaking, production locations are not public, but in my experience, both reveal some information. Generic drug manufacturers are likely to disclose more information than brand drug manufacturers, which are more decentralized in their production.

GLG: is single supply more common than dual supply?

Steven Lynn: because of the pressure from FDA, brand drug manufacturers are likely to use dual sources of supply. In the case of generic drugs, dual sources of supply may not be so common because of the higher cost and the fact that many generics do not make much money.

In fact, some of these companies are losing money, but for the sake of public health, they still need to produce these drugs. In a way, the new coronavirus crisis can provide us with an opportunity to

Analyze the supply chain and understand the drugs we are producing, where they are produced, and the sources of their active ingredients. If the source of supply is China, do we have another source of supply? If not, do we have enough internal supply? How long is it going to run out? If there is another supplier, do they have the capacity to increase production and do they need FDA approval?

In this regard, it would be helpful to have a dual source of supply and own production facilities. For contract manufacturers who deal with multiple customers, they need to do everything possible to satisfy a large number of customers – say, 50 customers – so they have to prioritize the most important drugs, such as oncology or emergency medicine.

But the biggest question is whether they have all the raw materials they need and whether they have the ability to complete production in a specific time.

GLG: let’s talk about supply again. Do these companies have sufficient inventory of raw materials?

Steven Lynn: in my experience, many manufacturers have warehouses full of raw materials or APIs. But because of the improvement of manufacturing process in recent years, I don’t remember anyone who has enough stock on hand for several years.

It’s hard to say how many manufacturers are adopting lean supply, which is a trade-off between risk and reward – because it costs to store APIs, especially those that need to be refrigerated or frozen. Especially in some warmer climates, there is always a temperature problem.

GLG: finally, as a former official of the FDA, what measures do you think the FDA should take at present?

Steven Lynn: I think they may have done something about it. Personally, I might ask analysts to analyze and get as much up-to-date information as possible, including the inventory of APIs, how many manufacturing sites are registered in China and around the world, where they are located, and how long they can supply finished products to the United States.

The FDA, and investigate what companies are doing that report drug shortages. The FDA will also look for companies that have been approved to produce the drug but have not yet produced it to see if they are willing to do so. Of course, the FDA can’t force any manufacturer to produce products, but manufacturers usually start production voluntarily, especially when there is a public health need.

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