The federal push to make more medicine in the US, and where generics fit

"As of 2025, only 9% of API manufacturers are in the U.S., compared to 22% in China and 44% in India," FDA said on Oct. 3, 2025, in the announcement of a pilot program¹ meant to reward generic drug makers that manufacture and test at home. The same notice said more than half of pharmaceuticals distributed in the US are made overseas.

That statement came at the end of five years of federal orders aimed at the same gap, and six months before the first tariffs on imported medicines. Since 2020 the government has pulled three kinds of levers: stockpiles, regulatory incentives for domestic plants, and trade measures. Generic drugs, which fill most US prescriptions, have been treated differently under each.

The executive orders, proclamations and Federal Register notices themselves spell out what each measure does and what it leaves open. For background on how ingredients move from chemical plants to pharmacy shelves, see GxRadar's explainer on where drug ingredients come from.

How much is made at home depends on who is counting

Federal documents measure import reliance in different ways, so the numbers do not line up neatly. Each figure below carries its own scope.

Those finished-product figures come from FDA's pilot announcement¹ and Executive Order 14336⁴; the patented-drug figures come from the April 2026 tariff proclamation⁶. The gap between finished products and ingredients is the point. A tablet can be pressed and packaged in the US from an active ingredient made somewhere else.

Two stockpiles with different jobs

ASPR, the Administration for Strategic Preparedness and Response within HHS, runs the Strategic National Stockpile. According to ASPR's description⁸, the stockpile holds large quantities of medicines, vaccines and other supplies for chemical, biological, radiological and nuclear threats, emerging infectious diseases and pandemics. ASPR calls it a safety net for when state and local resources run out or critical products are not commercially available during an emergency. Many of the countermeasures it holds are not sold anywhere else.

A second, newer reserve holds drug ingredients instead of finished products. Executive Order 14336, signed Aug. 13, 2025, set out the logic for the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR): APIs are generally cheaper and have longer shelf lives than the finished products made from them, and government purchases can encourage domestic API production. The order⁴ described the reserve as nearly empty and set deadlines.

• Within 30 days, ASPR was to list about 26 drugs especially critical to national health and security, and identify existing funds to pay for the reserve.
• Within 120 days, subject to funding, ASPR was to ready the existing repository to receive and store APIs.
• ASPR was then to buy a six-month supply of APIs for those critical drugs, preferring domestically made APIs where possible.
• Within 90 days, ASPR was to update its 2022 list of 86 essential medicines and plan a six-month API supply for those drugs too, with a cost estimate for a second repository.

Where the essential medicines list came from

That list of 86 traces back to Executive Order 13944², signed Aug. 6, 2020. It set a policy of building domestic supply chains for essential medicines, medical countermeasures and their critical inputs, and directed agencies to use their procurement authority to limit some purchases to products made in the US. Where appropriate, agencies were to split contracts among two or more US manufacturers.

FDA got its own assignment in the 2020 order. It was told to identify, within 90 days, the medicines and inputs that are medically necessary to have available at all times. FDA published that list in October 2020. ASPR later narrowed it to 86 essential medicines in 2022, the list the 2025 reserve order⁴ builds on. Drugs that are short today are tracked on GxRadar's shortage page, and the piece on sterile injectable shortages explains why hospital drugs run short most often.

Speeding up new plants

Executive Order 14293³, signed May 5, 2025, went after the time it takes to build. It cited industry estimates that new capacity for drugs and critical inputs can take five to 10 years. It directed FDA, within 180 days, to review its regulations and guidance on new and expanded domestic manufacturing and remove duplicative requirements.

Overseas plants were the other target. The order asked FDA to strengthen risk-based inspections of overseas plants, funded by higher fees on foreign facilities where the law allows, and to publish annual counts of foreign inspections by country and manufacturer. The Environmental Protection Agency was named lead agency for permitting plants that need an environmental impact statement. GxRadar's explainer on FDA inspections covers what those visits involve.

FDA answered with two programs. FDA PreCheck, the subject of a public meeting the week of the pilot announcement, uses what the agency calls a two-phase approach¹ to speed the establishment of high-priority new manufacturing facilities in the US. The Oct. 3 pilot is aimed squarely at generics. Under it, abbreviated new drug applications (ANDAs) are eligible for priority review if any required bioequivalence testing was done in the US and the product is made in the US using exclusively domestic sources¹ of API. The process those applications go through is described in how a generic drug gets approved, and approval counts by year are on the GxRadar approvals page.

The Section 232 tariffs, and the generic exemption

On April 1, 2025, the Secretary of Commerce opened an investigation under section 232 of the Trade Expansion Act of 1962 into whether imports of pharmaceuticals and their ingredients threaten national security. The notice of the investigation⁵ covered finished generic and non-generic drugs, medical countermeasures, APIs and key starting materials.

Proclamation 11020, signed April 2, 2026, acted on the findings, but only for patented drugs and their ingredients. According to the proclamation⁶, it took effect on July 31, 2026, for a listed group of companies and on Sept. 29, 2026, for all others.

Under the proclamation's own terms⁶, the decision not to tariff generics extends to purchases of generic drugs and ingredients for the Strategic API Reserve. It also directs Commerce to tell the President, within one year, of any circumstances that might call for action on generic imports. A Commerce notice published Sept. 23, 2026⁷, repeated that the pharmaceutical tariffs do not currently apply to generic products and associated ingredients.

For generic prices, that exemption matters because the margins are thin. GxRadar's piece on the long deflation of generic prices shows how far per-tablet costs have fallen, and any future tariff on ingredients would apply to products that often cost pharmacies a few cents a unit.

Dates still open

Most of these measures work on a long clock. The May 2025 order³ itself cited estimates of five to 10 years to bring new capacity online, and the reserve order⁴ asked ASPR for a plan and cost estimate for a second API repository that has no fixed completion date.

The nearest firm deadline is the Commerce review of generic imports. Counting one year from the April 2, 2026, proclamation, it falls due by April 2, 2027. Until then, the generic exemption stands on language the proclamation⁶ frames as applying "at this time," so its status is worth checking against the latest Federal Register notices.