Suppliers and packagers for generic pharmaceutical drug: BREMELANOTIDE ACETATE

BREMELANOTIDE ACETATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557	NDA	Cosette Pharmaceuticals, Inc.	0713-0897-04	4 SYRINGE in 1 CARTON (0713-0897-04) / .3 mL in 1 SYRINGE (0713-0897-06)	2025-11-12
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557	NDA	Palatin Technologies	80064-141-02	2 SYRINGE in 1 CARTON (80064-141-02) / .3 mL in 1 SYRINGE (80064-141-01)	2019-06-21
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557	NDA	Palatin Technologies	80064-141-04	4 SYRINGE in 1 CARTON (80064-141-04) / .3 mL in 1 SYRINGE (80064-141-01)	2019-06-21

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: Bremelanotide Acetate

Introduction
Bremelanotide acetate, marketed under brand names such as Vyleesi, is a synthetic peptide used primarily for the treatment of hypoactive sexual desire disorder (HSDD) in women. Its therapeutic efficacy and market acceptance depend heavily on the availability of high-quality suppliers capable of consistent, large-scale production. This article explores the key suppliers involved in the supply chain of bremelanotide acetate, analyzing manufacturing sources, global distribution channels, and industry collaborations.

Manufacturers of Bremelanotide Acetate

1. Major Innovators and Patentees
Bremelanotide was developed by Palatin Technologies, Inc., a biotechnology firm focused on peptide-based therapeutics. Initially, Palatin held the clinical rights, with subsequent partnerships and licensing agreements facilitating production and commercialization. The active pharmaceutical ingredient (API) synthesis is often carried out by specialized peptide contract manufacturing organizations (CMOs). As of 2023, Palatin partnered with several CMOs to scale production, including leading firms capable of peptide synthesis at GMP (Good Manufacturing Practice) standards.

2. Contract Manufacturing Organizations (CMOs)
The production of peptides like bremelanotide requires sophisticated peptide synthesis techniques, employing solid-phase peptide synthesis (SPPS) and purification processes to ensure purity and stability. The following are key CMOs with documented capabilities in peptide manufacturing relevant to bremelanotide acetate:

• Bachem AG
  Bachem is a global leader in peptide synthesis, offering GMP-grade peptides for pharmaceutical development and commercial supply. They have extensive experience with peptide APIs, including complex analogs, and have supplied peptides to several clinical trials and commercial projects. Their facilities adhere to stringent regulatory standards, making them a prime candidate for bremelanotide acetate supply.

• Peptide2.0
  Based in the United States, Peptide2.0 specializes in custom peptide synthesis for research and clinical applications. They possess scalable GMP facilities capable of producing peptides like bremelanotide at commercial quantities.

• Aston University’s Peptide Synthesis Service
  While primarily an academic service, Aston University collaborates with commercial partners to scale peptide production. They possess specialized expertise in peptide stability and formulation, although their primary focus remains academic.

• Wuxi AppTec
  A Chinese-based global contract research organization (CRO) and CMO, Wuxi AppTec offers peptide synthesis and manufacturing within its integrated platform. The company emphasizes high-quality GMP production and has expanded its peptide portfolio to include complex APIs like bremelanotide.

3. Key Raw Material Suppliers
Securing a reliable supply chain begins with sourcing high-purity raw materials, particularly amino acids and coupling reagents. Leading suppliers include:

• Cambridge Isotope Laboratories
  Offers isotopically labeled amino acids and reagents essential for peptide synthesis.

• MilliporeSigma (Merck KGaA)
  Provides bulk chemicals, amino acids, and solvents used in peptide manufacturing, ensuring quality and regulatory compliance.

• Jubilant Ingrevia
  A global API and specialty chemicals manufacturer, supplying amino acids and peptide intermediates suitable for bremelanotide synthesis.

Global Distribution and Supply Chain Dynamics

1. Regulatory Considerations
Distribution of bremelanotide acetate hinges on GMP compliance, export regulations, and therapeutic-specific approvals. Companies like Palatin and manufacturing partners must navigate regions’ regulatory landscapes, including the FDA (United States), EMA (Europe), and other national agencies. Distributors with established logistics networks, cold chain capabilities, and quality assurance measure ensure the integrity of the peptide during transit.

2. Geographical Focus

• North America: The primary market for bremelanotide, with suppliers like Palatin partnering with North American CMOs for direct distribution.
• Europe and Asia: Increasing manufacturing capabilities in Europe and China diversify supply sources, reduce costs, and mitigate geopolitical risks. Wuxi AppTec and other Asian CMOs play an expanding role in fulfilling global demand.

3. Industry Collaborations
Strategic collaborations bolster supply chain stability. Palatin’s licensing agreements with pharmaceutical giants, including collaborations with global CMOs, enable scalable production. Such partnerships often include clauses for technology transfer, quality oversight, and capacity expansion.

Market Outlook and Supply Chain Challenges

• As bremelanotide transitions from development to commercial realization, ensuring a steady supply of high-quality peptides becomes crucial. Long lead times for peptide synthesis, high production costs, and complex purification processes pose ongoing challenges.

• The emergence of biosimilar or alternative peptide suppliers could impact pricing and availability, prompting incumbent suppliers to invest in process optimization.

• Regulatory harmonization and Certificate of Good Manufacturing Practice (CGMP) certifications are vital for market access across multiple jurisdictions.

Conclusion
The supply chain for bremelanotide acetate is characterized by a network of specialized peptide manufacturers, raw material providers, and global distribution entities. Leading firms like Bachem AG, Wuxi AppTec, and Peptide2.0 are central to ensuring consistent, high-quality supply, supported by contract partnerships and raw material sourcing from established chemical suppliers. As demand for this therapeutic grows, supply chain resilience will depend on scalable manufacturing, regulatory compliance, and strategic industry collaborations.

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Key Takeaways

• Major Suppliers: Leading peptide CMOs such as Bachem AG and Wuxi AppTec dominate the production of bremelanotide acetate, with specialized expertise in GMP-grade peptide synthesis.
• Supply Chain Complexity: The manufacturing process involves high-purity raw materials, advanced synthesis techniques, and stringent quality controls, demanding robust supplier relationships.
• Geographical Diversification: The industry is shifting towards geographically diversified manufacturing, including North America, Europe, and Asia, to enhance supply resilience and cost management.
• Regulatory Landscape: Compliance with GMP standards and active engagement with regulatory agencies are critical for distribution in global markets.
• Market Trends: Growing demand and new collaborations will drive manufacturing capacity expansion, with ongoing challenges including high production costs and technical complexity.

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FAQs

1. Who are the leading manufacturers of bremelanotide acetate?
Major manufacturing responsibilities are distributed among contract manufacturing organizations like Bachem AG (Switzerland), Wuxi AppTec (China), and Peptide2.0 (USA), all of which produce GMP-certified peptide APIs for clinical and commercial use.

2. What raw materials are critical for producing bremelanotide acetate?
Amino acids, coupling reagents, and solvents of high chemical purity, supplied by companies like MilliporeSigma and Cambridge Isotope Laboratories, are essential to peptide synthesis.

3. How does global regulation influence the supply of bremelanotide?
Regulatory compliance, including GMP certification and regional approvals, impacts manufacturing, export, and distribution strategies, with companies partnering closely with authorities such as the FDA and EMA.

4. Are there regional differences in sourcing for bremelanotide?
Yes. North American and European markets primarily rely on domestic or partnered manufacturers, while China and Asia are becoming increasingly prominent due to their growing peptide manufacturing capabilities and cost advantages.

5. What factors could disrupt the supply chain of bremelanotide acetate?
Technical complexities in peptide synthesis, raw material shortages, regulatory delays, geopolitical tensions, and environmental factors could impact supply continuity. Strategic sourcing, redundancy, and ongoing process innovation are vital to mitigate these risks.

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Sources
[1] Palatin Technologies, Inc. Official Website. (2023). "Bremelanotide and Collaborations."
[2] Bachem AG. Corporate capabilities overview. (2023).
[3] Wuxi AppTec. Peptide manufacturing services. (2023).
[4] Peptide2.0. Custom peptide synthesis. (2023).
[5] MilliporeSigma. Chemical and peptide raw materials. (2023).