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Suppliers and packagers for generic pharmaceutical drug: ETELCALCETIDE
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ETELCALCETIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Kai Pharms Inc | PARSABIV | etelcalcetide | SOLUTION;INTRAVENOUS | 208325 | NDA | Amgen Inc | 55513-740-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55513-740-10) / .5 mL in 1 VIAL, SINGLE-DOSE (55513-740-01) | 2017-04-03 |
| Kai Pharms Inc | PARSABIV | etelcalcetide | SOLUTION;INTRAVENOUS | 208325 | NDA | Amgen Inc | 55513-740-20 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55513-740-20) / .5 mL in 1 VIAL, SINGLE-DOSE (55513-740-01) | 2017-04-03 |
| Kai Pharms Inc | PARSABIV | etelcalcetide | SOLUTION;INTRAVENOUS | 208325 | NDA | Amgen Inc | 55513-741-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55513-741-10) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-741-01) | 2017-04-03 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Etelcalcetide
Introduction
Etelcalcetide (trade name: Parsabiv) is a calcimimetic agent primarily prescribed to manage secondary hyperparathyroidism (SHPT) in patients undergoing maintenance hemodialysis. Its complex synthesis, high specificity, and regulatory requirements have established a concentrated global supply chain predominantly controlled by a few biotechnology entities. Understanding the procurement landscape for etelcalcetide is essential for pharmaceutical companies, healthcare providers, and stakeholders involved in dialysis treatment, drug manufacturing, or supply chain planning.
Manufacturers of Etelcalcetide
Currently, etelcalcetide is exclusively marketed by Kyowa Kirin, a Japanese biopharmaceutical company specializing in peptide therapeutics. The drug was developed through a licensing agreement with Entera Bio, and its commercial production is centralized under Kyowa Kirin’s manufacturing infrastructure.
Kyowa Kirin’s Role
Kyowa Kirin holds exclusive rights to produce, distribute, and market etelcalcetide globally, positioning it as the primary supplier [1]. The company's proprietary peptide synthesis processes and strict quality controls ensure high purity and efficacy, but they also limit the number of alternative suppliers.
Contract Manufacturing and Supply Chain Partners
While Kyowa Kirin manages global distribution, the drug’s active pharmaceutical ingredient (API)—a synthetic peptide—may be produced through contracted manufacturing organizations (CMOs) in strategic locations such as Japan, South Korea, or China. These CMOs operate under strict Good Manufacturing Practice (GMP) standards to ensure quality and regulatory compliance [2].
Supply Chain Dynamics and Key Suppliers
1. API Synthesis and Procurement
The peptide API synthesis involves complex solid-phase peptide synthesis (SPPS) technology, high purity reagents, and specialized equipment. The initiation and scale-up of API manufacturing are undertaken internally by Kyowa Kirin or through selected CMOs with proven peptide synthesis capabilities.
2. Raw Material Suppliers
Peptide synthesis depends on high-quality amino acids, coupling reagents, and solvents. Leading raw material suppliers include firms such as FStar Chemical, Novabiochem (MilliporeSigma), and Bachem, which supply key intermediates and peptides for pharmaceutical applications [3].
3. Filling, Finishing, and Packaging
Once the API is synthesized, it is processed into injectable formulations. These operations are typically performed within controlled manufacturing facilities under strict regulatory oversight. Kyowa Kirin handles fill-finish operations either internally or via dedicated contract manufacturers.
4. Distribution and Logistics
Given the sensitive nature of peptide drugs, temperature-controlled logistics are imperative. Kyowa Kirin oversees global distribution channels, which include logistics providers specializing in cold chain transportation.
Emerging and Alternative Suppliers
Despite Kyowa Kirin’s firm hold on etelcalcetide's development and commercialization, potential alternative suppliers may emerge through several avenues:
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Contract Manufacturing Expansion: Larger CMOs with peptide synthesis expertise, such as Samsung Biologics or Cytiva (formerly GE Healthcare), could extend capabilities to produce etelcalcetide if demand increases or Kyowa Kirin licenses production rights.
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Generic Development: Currently, etelcalcetide is under patent protection, limiting generic manufacturing. However, patent expiration would open the market to biosimilar and generic entrants, similar to other peptide therapeutics.
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Regional Suppliers: Asian manufacturing hubs, particularly in China and India, possess emergent peptide synthesis capabilities. Although these suppliers are not currently approved for etelcalcetide, they could potentially develop production pathways under licensing agreements or licensing negotiations.
Regulatory and Intellectual Property Considerations
Kyowa Kirin’s patent portfolio consolidates its exclusive supply rights, covering composition of matter, manufacturing processes, and uses. New entrants seeking to supply etelcalcetide must navigate complex patent landscapes, obtain regulatory approvals, and ensure compliance with international standards [4].
Regulatory hurdles, including FDA and EMA approvals, demand extensive validation, stability testing, and manufacturing process controls. Installation of dedicated manufacturing infrastructure or licensing agreements will be prerequisites for new suppliers.
Strategic Implications for Stakeholders
Pharmaceutical Companies:
Access to etelcalcetide APIs requires strategic licensing negotiations with Kyowa Kirin or the development of alternative peptides via innovative synthesis techniques.
Healthcare Providers:
Understanding the sole-source nature of etelcalcetide emphasizes the importance of supply chain resilience and contingency planning, especially amid potential disruptions in manufacturing or logistics.
Investors and Market Analysts:
The future landscape of etelcalcetide suppliers hinges on patent expirations, licensing opportunities, and regional generic biosimilar development. Monitoring Kyowa Kirin’s patent filings and international regulatory filings offers insights into upcoming market entries.
Conclusion
Only a limited number of suppliers and manufacturing partners currently facilitate the global supply of etelcalcetide, primarily under Kyowa Kirin’s control. The high complexity of peptide synthesis, coupled with regulatory barriers, restricts supplier diversity at this stage. However, future developments—including patent expirations, technological advances, and regional manufacturing capacity expansions—may diversify the supply landscape, providing new opportunities for entrants and impacting market competition.
Key Takeaways
- Kyowa Kirin remains the exclusive manufacturer and distributor of etelcalcetide globally.
- The active pharmaceutical ingredient (API) is produced through specialized peptide synthesis, primarily handled in-house or via trusted CMOs.
- Raw materials are sourced from leading chemical suppliers with expertise in high-purity amino acids and reagents.
- Supply chain resilience depends on maintaining strict cold chain logistics and regulatory compliance.
- Potential future suppliers could emerge post-patent expiry or through licensing agreements with regional manufacturers.
FAQs
1. Who are the current suppliers of etelcalcetide?
Kyowa Kirin is the sole approved supplier of etelcalcetide, controlling manufacturing, distribution, and marketing internationally.
2. Can other companies produce etelcalcetide?
Only if licensed or authorized by Kyowa Kirin, given existing patents and regulatory controls. Future generics would require patent expiration or licensing agreements.
3. What are the main raw materials used in etelcalcetide production?
High-purity amino acids and reagents required for peptide synthesis, supplied by firms such as Novabiochem, Bachem, and others.
4. Are there alternative ways to source etelcalcetide?
Regional peptide synthesis capabilities exist, but currently, no alternatives are authorized or certified for commercial supply.
5. What impact could patent expirations have on the supply landscape?
Patent expiration could enable biosimilar manufacturers to develop or license alternative production pathways, increasing supply options and potentially reducing costs.
References:
[1] Kyowa Kirin. (2021). Product Overview: Parsabiv (etelcalcetide).
[2] FDA. (2022). Guidelines for peptide API manufacturing.
[3] Novabiochem. (2023). High-purity amino acids for pharmaceutical synthesis.
[4] WIPO. (2022). Patent landscapes surrounding calcimimetics.
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