USP: India and China continue their API manufacturing reign

Companies in India, China, and Europe continue to play an outsized role in manufacturing active pharmaceutical ingredients (API) used in products destined for the US market in terms of locations cited in API drug master files (DMFs) filed with the US Food and Drug Administration (FDA).

According to the US Pharmacopeia’s (USP) Medicine Supply Map, only 4% of the active API DMFs filed with FDA in 2023 cited US manufacturing facilities; 50% were held by India, followed by China at 32%, the EU at 10% and other countries at 4%. DMFs are submitted to FDA by companies supplying drug ingredients to another company and are confidential and stripped of proprietary information. USP notes that not all drug products are made with APIs referencing DMFs, and that the proportion of DMFs is not necessarily indicative of total output by a country or region.

Instead, USP said the geographical analysis of DMFs can shed light on global manufacturing trends. When looking at total active DMFs, India remains in the lead globally, with 48%, followed by the EU with 17%, China with 16%, and the US with 9%.

USP said the 2023 data highlights a “dynamic and evolving” landscape with respect to API manufacturing. In 2000, facilities in India represented 19% of API DMFs filed that year. By 2021, India’s share increased to 62% of filings, which decreased to 50% of filings in 2023. Despite its decrease in annual filings, India’s total share of active API DMFs remains unchanged at 48%, while both the US and EU saw a decline in total active DMFs, and China saw an increase driven by a sharp uptick in DMFs filed in 2023.

China’s API manufacturing capacity has also shown a “striking rise in recent years,” USP wrote. In 2021, companies in China filed 134 API DMFs, and by 2023, this number surged to 219, marking a 63% increase in two years. USP said “this growth highlights China’s expanding role in global API production,” though the organization said that pending legislation, such as the BIOSECURE Act, “may impact DMF submissions in the future.” The act prohibits companies that receive federal funds from using biotechnology that is sourced from a US foreign adversary. The House of Representatives passed the bill on 9 September and the measure is currently pending in the Senate.

The report also found that Europe’s share of newly filed API DMFs decreased from 42% in 2000 to 7% in 2021 and is currently at 10% in 2023. “While this represents a small recovery, it still reflects a long-term trend of decreasing API manufacturing activity within Europe,” said USP. The US remained steady at 4% of API DMFs filed in both 2021 and 2023.

Vimala Raghavendran, senior director of the USP pharmaceutical supply chain center, told Focus that the big takeaway is that the API market is “getting a lot more concentrated” and China’s position as a major API supplier has increased over the last few years.

She added that having a geographically diverse manufacturing base can help to reduce supply chain vulnerabilities.

Raghavendran further noted that the main purpose of the map is to provide visibility into the supply chain to help manufacturers plan for and avert potential drug shortages. “You won’t know where the vulnerabilities are unless you map that,” she said.

USP

USP: India and China continue their API manufacturing reign

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