US FDA Establishes "Green List" for Foreign GLP-1 Ingredient Makers Amid Concerns Over Counterfeit Drugs

Eli Lilly & Co. and Novo Nordisk A/S shares fell after the FDA established a "green list" of foreign manufacturers producing raw materials for GLP-1 drugs. The list includes over three dozen manufacturers, but their names are redacted. Raw materials from non-listed manufacturers may be subject to detention if imported. Novo called for effective implementation of the import alert to protect patients from safety risks posed by knockoff drugs.

The U.S. Food and Drug Administration (FDA) has implemented a significant regulatory measure by establishing a "green list" of foreign manufacturers producing raw materials for GLP-1 drugs. This move aims to enhance the safety and quality of imported active pharmaceutical ingredients (APIs) used in these medications. The announcement has had immediate market implications, with shares of Eli Lilly & Co. and Novo Nordisk A/S falling on Friday.

The FDA's action is part of its broader strategy to safeguard consumers from potentially dangerous GLP-1 drugs. The "green list" includes manufacturers that appear to comply with the FDA's rigorous standards. APIs from manufacturers not on the list may be subject to detention without physical examination if imported. This measure is particularly relevant given the FDA's previous concerns about compounded versions of GLP-1 drugs like semaglutide and tirzepatide, which are not approved by the FDA and can pose safety risks.

The green list is a proactive step to protect patients who use these compounded drugs. It is part of the FDA's ongoing efforts to monitor the market and take enforcement actions against unsafe or fraudulent drugs. The FDA has emphasized its commitment to ensuring the safety of all active ingredients used in GLP-1 drugs.

The impact on Eli Lilly and Novo Nordisk is significant. Both companies have been involved in legal efforts to block compounders from selling alternative versions of their GLP-1 drugs, particularly Wegovy and Mounjaro. The FDA's green list could exacerbate the legal and regulatory challenges they face, as it makes it more difficult for compounders to source compliant APIs.

Novo Nordisk has called for effective implementation of the import alert to protect patients from the safety risks posed by knockoff drugs made with inauthentic or substandard APIs. The company has expressed concerns about the potential for these drugs to enter the U.S. market and cause harm to patients.

The regulatory landscape for GLP-1 drugs is complex and evolving. The FDA's green list is one of several measures aimed at ensuring the safety and efficacy of these medications. As the market for GLP-1 drugs continues to grow, particularly in the treatment of type 2 diabetes and chronic weight management, the regulatory environment will remain a critical factor in shaping the future of these drugs.

References:
[1] https://www.fda.gov/news-events/press-announcements/fda-launches-green-list-protect-americans-illegal-imported-glp-1-drug-ingredients
[2] https://www.bloomberg.com/news/articles/2025-09-05/lilly-novo-sink-on-fda-list-of-foreign-glp-1-ingredient-makers