Corrected October 19, 2026. An earlier version of this article, first published May 29, 2026 and based on a trade-press report, said the FDA added 38 foreign peptide API manufacturers to Import Alert 66-40 in a single action. We could not confirm that against the FDA's own list, so we have removed it and rewritten the article from the FDA record.
What Import Alert 66-40 Is
Import Alert 66-40, “Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs,” lets the FDA hold drugs at the US border without testing them when a foreign firm has been found out of compliance with current good manufacturing practice. The firms are named on the alert's public red list, with the date each was added. The alert dates back to 1988 and now lists firms from many countries, from API makers to cosmetics companies.
Listing usually follows an FDA inspection, a refused inspection, or a records request the firm did not satisfy. A firm comes off the list once the FDA accepts that the problems have been fixed, usually after a re-inspection.
Peptide API Makers Added in 2026
The FDA adds firms one at a time throughout the year. In 2026 the additions included two companies that hold US Drug Master Files for GLP-1 peptide APIs:
- Chengdu Shengnuo Biopharm (China), added September 19, 2026, covering all drugs and drug products from its Chengdu facility. It holds US DMFs for semaglutide, tirzepatide, liraglutide and retatrutide API.
- Reliance Life Sciences (India), added July 9, 2026, covering all drugs and drug products it manufactures. It holds a US DMF for liraglutide API.
A DMF filing and an import alert can exist at the same time. A DMF only means the company submitted manufacturing information to the FDA. It is not an approval and does not mean the site is currently in good standing.
GLP-1 APIs Have a Second Gate: Import Alert 66-80
In September 2025 the FDA added a stricter rule for GLP-1 APIs such as semaglutide and tirzepatide. Under Import Alert 66-80, GLP-1 API shipments can be detained unless the manufacturer is on the FDA's “green list” of firms it considers compliant. For these molecules, a supplier that is merely absent from the 66-40 red list is not enough. It also needs to be on the 66-80 green list.
How to Check a Supplier
- Get the manufacturer's exact legal name and facility address, not just a trading or brand name.
- Search that name on the Import Alert 66-40 red list. Note that a large company may have one site listed and others not.
- For GLP-1 APIs, confirm the manufacturer is on the Import Alert 66-80 green list.
- Check the FDA warning letter database for the same legal name.
- Repeat the check before each new order. The list changes every few weeks.
When we find a listed company, or one of its sites, on the red list, its profile in this directory carries an FDA import alert notice. See also our GLP-1 API manufacturer list and Chinese peptide suppliers.