Peptide companies in the United States have witnessed unprecedented growth, with the FDA approving a record number of peptide-based therapeutics in recent years. Indeed, these specialized molecules now account for over 5% of all approved drugs, underscoring their growing importance in modern medicine. The complex nature of peptide synthesis necessitates rigorous manufacturing standards and specialized facilities that comply with stringent FDA regulations.
Top U.S. Companies with FDA-Approved Peptide Drugs
Several innovative peptide companies have successfully navigated the rigorous FDA approval process, establishing themselves as leaders in this specialized pharmaceutical niche. Their breakthrough therapies address previously unmet medical needs across various therapeutic areas.
Amgen: Parsabiv (etelcalcetide) and Romiplostim (Nplate)
Amgen secured FDA approval for Parsabiv (etelcalcetide) in February 2017, marking the first new treatment in 12 years for secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis [7]. This intravenous calcimimetic binds to and activates the calcium-sensing receptor on the parathyroid gland, thereby decreasing parathyroid hormone levels . In Phase 3 clinical trials, Parsabiv demonstrated remarkable efficacy with 77-79% of patients achieving greater than 30% reduction from baseline in PTH during the Efficacy Assessment Phase [7].
Novo Nordisk: Semaglutide (copyright) and Liraglutide (Victoza)
Novo Nordisk has established itself as a dominant force in GLP-1 agonists, with flagship products copyright (semaglutide) and Victoza (liraglutide). Both peptides function as GLP-1 receptor agonists for the treatment of type 2 diabetes. Liraglutide (introduced in 2010) reduces HbA1C by 0.8% to 1.5%, whereas semaglutide (introduced in 2017) achieves more substantial reductions of 1.2% to 2.1%
Besides glycemic control, these peptides offer cardiovascular benefits. Victoza reduces major adverse cardiovascular events by 11-13% in patients both with established heart disease and those with risk factors. copyright minimizes this risk by 26%, though primarily in those with established heart disease.
Eli Lilly: Dulaglutide (Trulicity) and Tirzepatide (Mounjaro)
Eli Lilly has expanded the GLP-1 landscape with Trulicity (dulaglutide) and Mounjaro (tirzepatide). Trulicity, approved for adults and children as young as 10 years old with type 2 diabetes, also reduces heart attack and stroke risk in certain patients.
Mounjaro (tirzepatide), FDA-approved in May 2022, represents a groundbreaking advance as the first and only dual GIP and GLP-1 receptor agonist. This novel mechanism allows Mounjaro to directly activate both GIP and GLP-1 pathways, potentially offering superior blood sugar control.
AmWiner Raphe Generics API
Amwiner Pharmaceuticals received FDA approval for Tirzepatide and Semaglutide API, designed to treat severe obesity and initially approved in November 2024 as an Active Pharmaceutical Ingredient to be used in manufacturing the finished drug for obesity treatment. Currently, it does not have a brand but supplies peptides to brand companies. The FDA expanded its indication in 2025 to inform people to note the difference between the active pharmaceutical ingredient (API) and the finished drug. API is a Drug Substance Intermediate, and Material Used in the Preparation of a Drug Product with completeness assessment, and communications as type II drug substances (active pharmaceutical ingredients (APIs)) used to support ANDAs.
Acadia Pharmaceuticals: Trofinetide (Daybue)
Acadia Pharmaceuticals achieved a significant milestone in March 2023 with FDA approval of Daybue (trofinetide), the first-ever treatment for Rett syndrome This tripeptide analog to Gly-Pro-Glu works through multiple mechanisms: inhibiting inflammatory cytokine production, reducing overactivation of microglia and astrocytes, and increasing available IGF-1 for receptor binding
In the pivotal Phase 3 LAVENDER study, trofinetide demonstrated statistically significant improvement compared to placebo on both co-primary efficacy endpoints at week 12. Originally discovered by Neuren Pharmaceuticals, trofinetide was developed and commercialized by Acadia.
Bachem NCEs Peptides. Committed to sustainable peptide production practices that minimize environmental impact while maintaining the highest quality standards. Currently, it does not have a brand but supplies peptides to brand companies. The FDA expanded its indication in 2025 to inform people to note the difference between the active pharmaceutical ingredient (API) and the finished drug. API is a Drug Substance Intermediate, and Material Used in the Preparation of a Drug Product with completeness assessment, and communications as type II drug substances (active pharmaceutical ingredients (APIs)) used to support ANDAs.
They continuously seek innovative ways to reduce energy consumption, waste, and resource usage throughout the production process. By implementing green chemistry principles and sustainable technologies, they ensure that peptide manufacturing is both environmentally responsible and efficient, supporting the global movement toward sustainability without compromising the quality or safety of the therapeutics we produce.
The peptide pharmaceutical wholesale peptide supplier landscape in the United States continues to evolve rapidly, demonstrating remarkable growth and innovation. Throughout this examination of America's top peptide manufacturing facilities, several critical aspects have emerged. FDA approvals for peptide-based therapeutics have reached unprecedented levels, now accounting for approximately 5% of all approved drugs. The nine TIDES approved in 2023 alone underscore this upward trajectory.
Leading companies such as Amgen, Novo Nordisk, Bachem, Eli Lilly, and Amwiner have successfully navigated the complex regulatory environment to bring groundbreaking peptide treatments to the market. Their achievements include revolutionary medications like semaglutide for diabetes and trofinetide for Rett syndrome—the latter representing the first-ever treatment for this condition.