Suppliers and packagers for imcivree

imcivree

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Rhythm	IMCIVREE	setmelanotide acetate	SOLUTION;SUBCUTANEOUS	213793	NDA	Rhythm Pharmaceuticals, Inc	72829-010-01	1 VIAL, MULTI-DOSE in 1 CARTON (72829-010-01) / 1 mL in 1 VIAL, MULTI-DOSE	2020-12-14

Last updated: August 4, 2025

ppliers for the Pharmaceutical Drug: IMCIVREE

Introduction
IMCIVREE (setmelanotide) is a novel melanocortin-4 receptor (MC4R) agonist developed by Rhythm Pharmaceuticals. It is approved for treating severe obesity caused by rare genetic conditions, such as POMC deficiency, LEPR deficiency, and Bardet-Biedl Syndrome (BBS). As with other specialty pharmaceuticals, the supply chain for IMCIVREE involves an intricate network of raw material providers, active pharmaceutical ingredient (API) manufacturers, formulation specialists, and packaging entities. Understanding this network is essential for stakeholders seeking to ensure supply security, negotiate procurement, or evaluate risks associated with manufacturing and distribution.

Active Pharmaceutical Ingredient (API) Suppliers
The core of IMCIVREE’s production hinges on the availability of high-quality setmelanotide API. Rhythm Pharmaceuticals, the innovator behind IMCIVREE, sources the API from specialized contract manufacturing organizations (CMOs). These CMOs possess the technical expertise to synthesize complex peptides such as setmelanotide under stringent quality controls.

While Rhythm has not publicly disclosed all current API suppliers, industry sources suggest collaborations primarily with specialized peptide manufacturers in North America and Europe. Notably, peptide synthesis involves complex, multi-step processes that demand precision, high-purity reagents, and advanced chemistry capabilities. Key considerations include:

• Peptide synthesis capabilities: Companies with expertise in solid-phase peptide synthesis (SPPS), which is standard for peptides like setmelanotide.
• Supply chain resilience: Multiple sourcing options mitigate risks of bottlenecks.
• Regulatory compliance: Suppliers must adhere to Good Manufacturing Practice (GMP) standards.

Potential API suppliers include specialized peptide producers such as Bachem, CordenPharma, and Polypeptide Group. These companies are recognized for their GMP-certified peptide manufacturing facilities capable of producing complex APIs at commercial scales.

Raw Material Providers
Setmelanotide synthesis depends on high-purity amino acids, coupling reagents, solvents, and other chemical intermediates. These raw materials are procured from chemical suppliers with global reach, including:

• Merck KGaA (Sigma-Aldrich): Supplies amino acids, solvents, and reagents.
• Thermo Fisher Scientific: Provides chemical intermediates and laboratory-grade materials.
• Alfa Aesar (Thermo Fisher): Offers specialty chemicals necessary for peptide synthesis.

Ensuring stable raw material supply chains is crucial, especially given global disruptions seen in recent years affecting chemical manufacturing and logistics.

Formulation and Fill-Finish Suppliers
Post API synthesis, IMCIVREE is formulated into a stable injectable drug. The formulation process involves dissolving the API in a specific buffer system, sterile filtration, filling into vials or prefilled syringes, and packaging.

Major players involved in formulation and fill-finish services include:

• Catalent: A leading contract development and manufacturing organization (CDMO) with capabilities for sterile injectables.
• Fresenius Kabi: Known for high-quality aseptic filling and packaging of biologics and peptides.
• Boehringer Ingelheim: Offers formulation and fill-finish services for peptide drugs.

These firms operate GMP-compliant production facilities and often serve as primary manufacturing partners, especially for specialty products like IMCIVREE.

Distribution and Logistics
Ensuring consistent supply to patients involves a robust distribution network. Key considerations include cold chain logistics, regulatory compliance across jurisdictions, and inventory management.

Distribution is managed through alliances with specialized pharmaceutical distributors such as:

• McKesson Specialty Health
• Cardinal Health Specialty Distribution
• AmerisourceBergen

These distributors handle storage, transportation, and delivery, maintaining the cold chain integrity for peptide-based products like IMCIVREE.

Supply Chain Risks and Strategies
The small-molecule or peptide nature of IMCIVREE makes its supply chain vulnerable to factors such as:

• Manufacturing disruptions: Complex peptide synthesis is sensitive to process deviations.
• Raw material shortages: Dependence on specific amino acids and reagents can create bottlenecks.
• Regulatory complexities: Stringent GMP standards and regional regulatory requirements may delay production or approvals.
• Global logistics complications: Transportation delays could impact timely supply, especially during crises like pandemics.

To mitigate these risks, Rhythm Pharmaceuticals likely maintains multiple supplier agreements, invests in inventory buffers, and collaborates closely with manufacturing partners to ensure quality and supply continuity.

Emerging Trends and Future Outlook
As demand for rare disease therapies like IMCIVREE increases, biopharmaceutical companies are exploring innovation in manufacturing, such as:

• Enhanced peptide synthesis methods: Novel chemistries to improve yield and reduce costs.
• Strategic sourcing: Establishing dual sourcing agreements and regional manufacturing hubs.
• Enhanced supply chain transparency: Digital tracking and blockchain solutions to monitor raw material provenance and production stages.

It is anticipated that partnerships with established CDMOs and raw material suppliers will expand, ensuring consistent supply amidst rising global demand. Moreover, potential patent protections and exclusivity periods might influence supplier negotiations and pricing strategies.

Conclusion
The supply network for IMCIVREE underscores a complex interplay between specialized peptide synthesis, high-grade raw materials, formulation expertise, and global distribution. Guided by stringent regulatory standards, these supply chains aim to guarantee effective, safe, and timely access to this groundbreaking therapy for patients with rare obesity disorders.

Key Takeaways:

• IMCIVREE’s API is sourced from specialized peptide manufacturers with GMP capabilities, including companies like Bachem, CordenPharma, and Polypeptide Group.
• Raw materials for peptide synthesis are procured from global chemical suppliers such as Sigma-Aldrich and Thermo Fisher.
• Formulation and fill-finish are handled by CDMOs like Catalent and Fresenius Kabi, experienced in sterile peptide-based injectables.
• Distribution relies on specialized pharmaceutical logistics providers, emphasizing cold chain integrity.
• Managing supply chain risks involves diversified sourcing, inventory strategies, and close regulatory collaboration.

FAQs

1. Who are the primary API suppliers for IMCIVREE?
   Current publicly disclosed API suppliers are not specified; however, leading peptide manufacturing firms like Bachem, CordenPharma, and Polypeptide Group are likely candidates due to their GMP capabilities and expertise in peptide synthesis.

2. What raw materials are essential for manufacturing setmelanotide?
   High-purity amino acids, coupling reagents, solvents, and other chemical intermediates are critical components sourced from chemical suppliers such as Sigma-Aldrich and Thermo Fisher.

3. Which companies handle formulation and fill-finish for IMCIVREE?
   Firms like Catalent, Fresenius Kabi, and Boehringer Ingelheim serve as primary partners for formulating, sterilizing, and packaging IMCIVREE into injectable forms.

4. How does the supply chain mitigate risks associated with shortages or delays?
   Strategies include multi-supplier agreements, stockpiling, regional manufacturing partnerships, and close regulatory and logistics coordination.

5. Are there upcoming innovations that could impact the supply chain?
   Yes, advancements in peptide synthesis, digital transparency tools, and regionalized manufacturing are improving resilience and reducing costs in the supply chain for peptide-based biologics like IMCIVREE.

References
[1] Rhythm Pharmaceuticals, "IMCIVREE (setmelanotide) Prescribing Information", 2022.
[2] Bachem Annual Reports.
[3] CordenPharma Capabilities Overview.
[4] Polypeptide Group Capabilities.
[5] Sigma-Aldrich Product Catalogs and Supply Data.