Bulk Pharmaceutical API Sources for CIBACALCIN

Bulk Pharmaceutical API Sources for CIBACALCIN

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		T3660_SIGMA
AvaChem Scientific		47931-85-1
AvaChem Scientific		2217
BOC Sciences		47931-85-1

Bulk Active Pharmaceutical Ingredient (API) Sources for CIBACALCIN

Last updated: August 1, 2025

Introduction

Cibacalcin, a synthetic calcitonin analogue, is a peptide hormone used primarily in the management of conditions like hypercalcemia, osteoporosis, and other metabolic bone diseases. Its efficacy relies heavily on the pharmaceutical-grade API, which must meet stringent purity and stability standards. Identifying reliable bulk API sources for Cibacalcin is crucial for pharmaceutical manufacturers to ensure supply continuity, compliance, and cost-effectiveness.

Pharmaceutical API Landscape for Cibacalcin

The procurement of Cibacalcin API hinges on specialized manufacturers with expertise in peptide synthesis and scalable production of synthetic peptides. The API is complex due to its peptide nature, requiring advanced manufacturing processes such as solid-phase peptide synthesis (SPPS), purification, and lyophilization.

Key criteria for API sources include:

• Compliance with Good Manufacturing Practice (GMP)
• Proven quality control (QC) and certification
• Capacity for large-scale production
• Competitive pricing and reliable supply chain

Major API Manufacturers and Suppliers

1. Bachem AG

   • Overview: A leading Swiss biotech company specializing in the synthesis of peptides, oligonucleotides, and complex APIs.
   • API Capabilities: Bachem offers custom peptide synthesis and has extensive experience producing calcitonin analogues, including synthetic Cibacalcin.
   • Certifications: GMP-certified facilities and comprehensive quality documentation.
   • Supply Chain: Recognized for reliable delivery and scale flexibility to meet both clinical and commercial demands.

2. Eurogentec (a part of BioPayne Group)

   • Overview: A Belgian biopharmaceutical company specializing in peptide synthesis and biotech reagents.
   • API Capabilities: Eurogentec provides custom peptide APIs, including peptide hormones akin to calcitonin derivatives, with tailored manufacturing processes.
   • Quality Assurance: GMP compliance and extensive QC protocols.

3. PolyPeptide Group

   • Overview: Danish-based global peptide manufacturer with broad production capacity.
   • API Capabilities: Expertise in peptide synthesis, purification, and formulation across diverse peptide pharmaceuticals.
   • Supply Considerations: Capable of producing GMP-grade API for clinical and commercial use.

4. Peptides & Compounds (P&C) China

   • Overview: Rapidly expanding manufacturer specializing in peptide APIs, including calcitonin analogues.
   • API Capabilities: Cost-effective synthesis at scale, with a focus on peptides for research and early-stage clinical development.
   • Quality Standards: Increasing adoption of GMP standards; potential for high-volume supply.

5. Merrifield Laboratory (New England Peptide)

   • Overview: U.S.-based peptide synthesis service offering both research-grade and GMP API production.
   • API Capabilities: Custom synthesis, including peptide hormones and analogs.
   • Certifications: GMP compliant, with robust quality documentation.

Emerging and Niche API Suppliers

• Caslo Laboratories Inc. (Canada) — An emerging provider of peptides for research purposes, with some capacity for GMP-grade API.
• Abzena (UK) — Offers advanced peptide synthesis services, including conjugation and modifications suitable for API production.

Supply Chain Challenges and Considerations

• Complexity of Peptide Synthesis: The peptide nature of Cibacalcin necessitates sophisticated manufacturing expertise, potentially limiting the number of qualified suppliers.
• GMP and Regulatory Compliance: Ensuring suppliers hold necessary certifications is vital, especially for APIs intended for human therapeutic use.
• Intellectual Property (IP): Some APIs, or their manufacturing processes, may be protected by patents, restricting sourcing options or increasing licensing costs.
• Cost and Lead Times: Peptide API manufacturing involves complex processes resulting in higher costs and longer lead times relative to small-molecule APIs.

Regulatory and Quality Assurance

Sourcing API for Cibacalcin requires scrutinizing certification documentation, including Drug Master Files (DMFs), batch records, and stability data. Suppliers must demonstrate adherence to regulatory standards, including ICH Q7 guidelines for APIs.

Future Trends and Opportunities

As biosimilar and peptide markets expand, more manufacturers invest in scalable peptide synthesis capabilities. Advances in peptide manufacturing—such as automated SPPS, improved purification techniques, and innovative stabilization methods—are likely to diversify available sources for peptide APIs like Cibacalcin.

Conclusion

Reliable sources for bulk Cibacalcin API predominantly include established peptide manufacturers such as Bachem, PolyPeptide, Eurogentec, and select regional suppliers in China and North America. The choice of supplier must align with regulatory standards, production scale, cost considerations, and supply reliability. As the peptide therapeutics market grows, expect increased competition and technological advancement to facilitate broader access to high-quality Cibacalcin API.

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Key Takeaways

• Leading Manufacturers: Bachem, PolyPeptide, Eurogentec are primary global suppliers with proven GMP compliance.
• Supply Chain Considerations: Due to peptide synthesis complexity, few suppliers can meet large-scale GMP demands for Cibacalcin.
• Regulatory Compliance: Ensuring suppliers provide comprehensive documentation and certifications is critical.
• Market Dynamics: Emerging Asian manufacturers offer cost-effective options but require rigorous quality oversight.
• Technological Advances: Innovations in peptide synthesis are improving scalability, purity, and stability, broadening API sourcing options.

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FAQs

1. What are the main challenges in sourcing Cibacalcin API?
   The peptide's complexity necessitates specialized manufacturing, and limited suppliers with GMP certification constrain supply options. Ensuring high purity, stability, and regulatory compliance adds further difficulty.

2. Which suppliers are considered the top for GMP-grade peptide APIs like Cibacalcin?
   Bachem, PolyPeptide, and Eurogentec are recognized for their expertise and GMP-certified peptide synthesis capabilities suitable for pharmaceutical APIs.

3. How do regional manufacturers compare in terms of quality and reliability?
   While regional suppliers such as Chinese peptide firms may offer cost advantages, rigorous due diligence regarding GMP compliance and quality assurance is essential to mitigate risks.

4. What role does regulatory compliance play in API sourcing?
   It is critical; suppliers must provide comprehensive documentation, including DMFs, stability data, and certifications, to meet regulatory standards for human clinical and commercial use.

5. Are there emerging technologies that could improve API sourcing for peptide drugs like Cibacalcin?
   Yes. Advances such as automated peptide synthesizers, improved purification methods, and stabilization techniques are expanding manufacturing capacity and reducing costs, which could enhance API availability in the near future.

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Sources:

[1] Bachem AG. "Peptide API Production." Bachem Corporate Website.
[2] PolyPeptide Group. "Peptide Manufacturing Capabilities." PolyPeptide Official Site.
[3] Eurogentec. "Custom Peptide Synthesis and API Production." Eurogentec Literature.
[4] U.S. Food and Drug Administration. "Guidelines for Peptide APIs." FDA.
[5] Market reports on peptide therapeutics manufacturing.