Suppliers and packagers for generic pharmaceutical drug: MACIMORELIN ACETATE

MACIMORELIN 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
Novo	MACRILEN	macimorelin acetate	FOR SOLUTION;ORAL	205598	NDA	Novo Nordisk	0169-1401-01	1 POUCH in 1 CARTON (0169-1401-01) / 60 mg in 1 POUCH	2022-01-31

Suppliers for the Pharmaceutical Drug: Macimorelin Acetate

Last updated: July 29, 2025

Introduction

Macimorelin acetate, marketed under the brand name Macrilen, represents a promising oral growth hormone secretagogue primarily used for diagnosing adult growth hormone deficiency (AGHD). Approved by the U.S. Food and Drug Administration (FDA) in 2019, the drug has gained attention within the pharmaceutical and healthcare sectors for its novel mechanism and clinical utility [1]. As demand increases, understanding the landscape of suppliers—ranging from raw material providers to finished drug manufacturers—is vital for stakeholders seeking reliable sourcing and strategic planning.

Overview of Macimorelin Acetate

Macimorelin acetate is a synthetic small-molecule GH secretagogue, which stimulates the secretion of growth hormone by acting on the ghrelin receptor. Its oral administration offers a significant advantage over traditional provocative tests requiring intravenous agents. The molecule's complex chemical synthesis necessitates specialized chemical suppliers and manufacturing partnerships to ensure quality and regulatory compliance.

Key Raw Material Suppliers

The primary raw materials for synthesizing macimorelin acetate are specialized chemical intermediates and active pharmaceutical ingredients (APIs). The sourcing of high-purity raw materials is critical to meet strict regulatory standards and ensure consistent drug performance.

• Chemical Intermediates Suppliers

  • Companies specializing in complex organic synthesis provide intermediates such as substituted amino acids, heterocyclic compounds, and precursors essential for macimorelin synthesis.
  • Notable players include Sigma-Aldrich (a Merck company), Thermo Fisher Scientific, and Alfa Aesar, offering high-grade chemicals compliant with pharmaceutical standards.

• Active Pharmaceutical Ingredient (API) Suppliers

  • As of now, macimorelin acetate APIs are primarily produced by contract manufacturing organizations (CMOs) with specialized capabilities in complex molecules.
  • Thermo Fisher Scientific and Lonza are leaders in providing pharmaceutical-grade intermediates and APIs globally.
  • Smaller, niche CMO firms specializing in peptide and small-molecule synthesis, such as WuXi AppTec and Cambrex, play roles in custom synthesis and scale-up.

Manufacturers of Macimorelin Acetate

The production of finished macimorelin acetate involves intricate chemical processes, strict quality controls, and adherence to Good Manufacturing Practices (GMP). The only approved commercial source in the U.S. is Hikma Pharmaceuticals, which licensed the drug from Millendo Therapeutics (now part of Strongbridge Biopharma) [2].

• Hikma Pharmaceuticals
  As the exclusive licensed manufacturer for Macrilen, Hikma oversees the entire manufacturing chain, from synthesis to formulation, ensuring compliance with FDA standards. The company’s facilities are certified for GMP production, guaranteeing batch-to-batch consistency.

• Contract Manufacturing Organizations (CMOs)
  Several CMOs with expertise in small-molecule synthesis are involved in early-stage synthesis, process validation, and scale-up before licensing agreements. These include:

  • WuXi AppTec
  • CordenPharma
  • Liomont (for regional distribution in Latin America)
  • Cambrex

Due to the complex synthesis, many CMOs focus on API production, with finished dosage formulation handled by specialized pharmaceutical companies.

Key Challenges in Supply Chain

Supply chain reliability stems from the molecule's complexity, regulatory hurdles, and patent protections. The synthesis process involves multiple steps, each requiring rigorous quality assurance. Additionally, tight regulatory environments restrict the number of authorized suppliers, which could pose risks of drug shortages or supply disruptions.

Emerging Suppliers and Market Dynamics

With the drug's relatively recent approval, the supplier landscape remains limited. However, industry trends suggest potential growth in manufacturing capacity:

• Expansion of Contract Manufacturing
  As demand grows, more CMOs will likely seek to develop capabilities for macimorelin acetate synthesis, driven by increasing diagnostic applications and potential research uses.

• Regional Suppliers
  Emerging suppliers in Asia and Europe are investing in R&D capacity to produce generic or biosimilar versions, which could influence pricing and availability over time.

• Regulatory Considerations
  Suppliers must navigate complex regulatory frameworks (FDA, EMA, etc.), ensuring batch documentation, stability data, and compliance.

Strategic Considerations for Stakeholders

• Supply Security: Collaborate with multiple sourcing partners or establish strategic alliances to mitigate supply risks.
• Quality Assurance: Prioritize suppliers with robust GMP compliance, validated processes, and transparent quality control measures.
• Cost Optimization: Monitor market trends, and consider long-term contracts with reliable CMOs to manage costs effectively.
• Future Proofing: Explore opportunities to develop in-house synthesis capabilities or secure licensing agreements for scaled manufacturing.

Conclusion

The supplier landscape for macimorelin acetate remains concentrated, owing to technical complexities and regulatory controls. Hikma Pharmaceuticals remains the sole licensed manufacturer in the U.S., with a limited but growing roster of contract manufacturers and raw material suppliers supporting global supply. Stakeholders must maintain diligence in supplier qualification, quality assurance, and regulatory compliance to ensure resilient sourcing of this innovative diagnostic agent.

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Key Takeaways

• Limited Supplier Base: Currently dominated by Hikma Pharmaceuticals, with a handful of specialized CMOs providing raw materials and manufacturing services.
• Complex Supply Chain: The synthesis and formulation require advanced expertise, which constrains the number of qualified suppliers.
• Regulatory Barriers: Strict regulatory standards limit supplier options and influence supply stability.
• Market Growth Potential: Increased diagnostic applications may drive expansion of manufacturing capacity and new supplier entrants.
• Strategic Sourcing: Diversification, quality assurance, and early partnership are essential for secure supply chains.

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FAQs

Q1: Who are the main global suppliers of macimorelin acetate APIs?
A1: Currently, the primary licensed manufacturer in the U.S. is Hikma Pharmaceuticals, with major API production involving contract manufacturing organizations like WuXi AppTec and Cambrex. Raw materials come from chemical suppliers such as Sigma-Aldrich and Alfa Aesar.

Q2: Are there any generic or biosimilar versions of macimorelin acetate available?
A2: No, as of now, macimorelin acetate remains proprietary, with no generic or biosimilar versions officially authorized. Future market entrants may change this landscape.

Q3: What are the key challenges in sourcing macimorelin acetate?
A3: Challenges include complex synthesis requiring high expertise, regulatory hurdles limiting supplier options, and ensuring consistent quality and supply chain resilience.

Q4: How is the supply chain for macimorelin acetate evolving?
A4: The supply chain is expected to expand as demand grows, with more contract manufacturers developing capabilities. Regional suppliers may emerge, influenced by market needs and regulatory environments.

Q5: What should stakeholders consider when selecting suppliers for macimorelin acetate?
A5: Focus on GMP compliance, manufacturing capacity, quality assurance, regulatory track record, and the ability to meet forecasted demand reliably.

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References

[1] FDA. (2019). FDA approves first oral drug to diagnose adult growth hormone deficiency.
[2] Millendo Therapeutics (now Strongbridge Biopharma). (2019). Licensing Agreement for Macimorelin.