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Big Pharma Tight-Lipped on Details of API Stockpile Deals

Key Takeaway: GSK, along with Bristol Myers Squibb and Merck, has committed to contribute active pharmaceutical ingredients to the U.S. Strategic Active Pharmaceutical Ingredients Reserve as part of a broader initiative to enhance supply chain resilience. While the agreements are framed as a means to ensure adequate supplies in emergencies, many specifics remain undisclosed, including the origins of the donated materials. This lack of transparency raises questions about the effectiveness and reliability of the initiative.
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POSITIVE FACTORS

  • GSK is contributing to national health security by donating APIs.
  • The agreements aim to reduce reliance on foreign nations for essential medicines.
  • The stockpile initiative is a proactive measure to mitigate future shortages.

CONCERNS & RISKS

  • Details of the agreements remain confidential, raising transparency concerns.
  • Uncertainty exists regarding the manufacturing locations of donated materials.
  • The secrecy around the donations may hinder public trust in the initiative.

BiopharmaWatch Analysis

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+13%
120-day peak, hindsight
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1.8%
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Lead asset
Otelixizumab
Phase 3 · Diabetes Mellitus, Type 1

Full Press Release Details

Bristol Myers Squibb, GSK and Merck delivered a show of support for the Trump administration’s supply chain resilience push late last year, committing materials to a stockpile to mitigate the risk of shortages. Weeks later, many details of the agreements remain private.
The White House ended 2025 by striking Most Favored Nation (MFN)pricing dealswith nine pharma companies. Leerink Partners and Truist Securities analystssaidthe terms of the deals were as expected, aligning with agreements the Trump administrationpreviously reachedwith five drugmakers. Companies are cutting some drug prices and selling products directly to patients in exchange for tariff relief.
While the headline terms of the newer deals were unsurprising, they included a new aspect, with BMS, GSK and Merck eachagreeingto contribute materials to the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR).
The White House framed the agreements as a way to “reduce reliance on foreign nations and ensure the United States has an adequate supply of such products in the event of an emergency.” Those goals have been cited as a reason for multiple actions that President Donald Trump has taken in his second term to date.
U.S. officials created SAPIR to stockpile active pharmaceutical ingredients (APIs) during Trump’s first term. After being re-elected, Trumporderedthe Office of the Assistant Secretary for Preparedness and Response (ASPR) to ready the existing repository to begin receiving and maintaining APIs, with the aim of building a six-month supply of APIs for essential medicines and medical countermeasures.
The Trump administration secured materials for the stockpile as part of the drug pricing deals. Merck will contribute 3.5 tons of the antibacterial ertapenem. GSK will provide 98.8 kg of albuterol, an API used in asthma rescue inhalers including the British drugmaker’s Ventolin. Albuterol is among the 86 medicines that the ASPRidentifiedas essential in 2022.
Emma Walmsley, in one of her last acts before stepping down as GSK CEO at the end of 2025,saidat a White House event to disclose the agreements that her company was “investing in American health security by donating the ingredients that go into rescue inhalers . . . so that people can access them when they need them.”
BMSsaidit will donate more than seven tons of API for its blood thinner Eliquis to fill SAPIR at no cost to taxpayers. The White House’s fact sheet on the deals said BMS will contribute tablets representing 6.5 tons of apixaban, the active ingredient in Eliquis and another of the 86 essential medicines. A BMS spokesperson toldBioSpacevia email that the specific terms of the agreement are confidential.
Cari Gallman, chief policy officer at BMS,saidat the White House event that her company was “answering the administration’s calls . . . to shore up the national medicine reserves” by agreeing to contribute to the stockpile.
While the Trump administration pitched the deals as a way to reduce reliance on foreign nations, it is unclear where the donated materials were manufactured. Trump’s 2025 SAPIR executive order leaves room for the ASPR to procure APIs from overseas, only directing the federal body to source materials from domestic manufacturers “where possible.”
The BMS spokesperson declined to say where the company made its donated apixaban API. BMS made the API at a site in Ireland until 2017, when itsoldthe facility. SK Biotek, one of BMS’ API suppliers, took ownership of the facility and continued to make the same portfolio of small molecule pharmaceutical products. BMSsaidin February 2025 that it relies on third parties for some or all of its apixaban needs.
A GSK spokesperson similarly declined to reveal where the donated albuterol was made, tellingBioSpacevia email that the company is not sharing any information beyond what it provided in its press release about the pricing deal.
An ASPR spokesperson toldBioSpacevia email that the agreements include confidential information and that no additional details can be disclosed. Merck did not respond to a request for comment. The secrecy means details, including when the companies will make the donations and which sites will store the APIs, remain private.
The extent to which the donations diverge from standard practices is unclear. Companies routinely store months of inventory. An nVentic analysisfound14 leading branded drugmakers had between 90 and 335 days’ inventory outstanding in 2024. Finished and work-in-progress goods account for some of the inventory, but APIs are an increasingly important part of the mix.
Average raw materials inventories in 2023werealmost double their pre-pandemic levels, according to nVentic. Holding larger API inventories can insulate companies from supply disruption, which became a growing problem as the pandemic interrupted established trade routes and increased demand for some drugs. Albuterol inhalerswereamong the products that were in short supply early in the pandemic.
The University of Utah’s Erin Fox, an expert in drug shortages, toldBioSpacevia email that there is no way to know how much API manufacturers keep in reserve because companies consider the information a trade secret.
However, having followed drug shortages for a long time, Fox suspects most companies keep at least 6 to 12 months’ worth of APIs that are not subject to Drug Enforcement Administration regulation. Fox’s hypothesis is that companies keep such reserves because it can take months for the FDA to approve a new source of API should companies need to switch, and pharma companies “want to be sure they can do all of their testing etc. and not have a gap in supply.”

Frequently Asked Questions

What is GSK contributing to the U.S. stockpile?

GSK is donating 98.8 kg of albuterol, an active pharmaceutical ingredient for asthma inhalers.

Why are the details of the agreements confidential?

The agreements include confidential information, and companies have not disclosed specific details.

What is the purpose of the Strategic Active Pharmaceutical Ingredients Reserve?

The reserve aims to ensure a reliable supply of essential medicines during emergencies.

Who else is involved in the stockpile agreements?

Bristol Myers Squibb and Merck are also contributing active pharmaceutical ingredients.

What concerns have been raised about the donations?

Concerns include the lack of transparency regarding the manufacturing locations of donated materials.

Last updated: Jan 27, 2026