Bulk Pharmaceutical API Sources for PARSABIV

Bulk Pharmaceutical API Sources for PARSABIV

Vendor	Vendor Homepage	Vendor Sku	API Url
DC Chemicals		DC8189
Chemenu Inc.		CM100712
MuseChem		I006723

Bulk Active Pharmaceutical Ingredient (API) Sources for Parsabiv (etelcalcetide)

Last updated: July 29, 2025

Introduction

Parsabiv (etelcalcetide) is a synthetic peptide used primarily in the management of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on dialysis. As a calcimimetic agent, its efficacy hinges on the manufacturing quality of its active pharmaceutical ingredient (API). Understanding sourcing options for parsabiv API is crucial for pharmaceutical manufacturers, procurement specialists, and strategists aiming to ensure supply chain stability, compliance with regulatory standards, and cost-effectiveness.

Overview of APIs in the Pharmaceutical Industry

APIs are the core components responsible for therapeutic activity in pharmaceutical products. Their sourcing often involves global supply chains, characterized by a few key manufacturers and numerous suppliers. For peptides like parsabiv, the production process is complex, involving advanced synthetic chemistry, peptide synthesis technology, and rigorous quality controls.

The API sourcing landscape is influenced by factors including manufacturing capacity, regulatory compliance, quality assurance, lead time, and geopolitical stability. For peptide APIs, quality standards such as Good Manufacturing Practices (GMP) certification from agencies like the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency) are non-negotiable.

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Major Global API Manufacturers for Parsabiv

1. Therasis SAS

Therasis SAS, based in France, is a notable contract manufacturer specializing in peptide synthesis, including complex APIs utilized in dialysis-related therapies. Their capabilities encompass GMP-certified production of peptide APIs and custom synthesis services.

Key Attributes:

• Proven expertise in peptide API manufacturing
• Extensive GMP compliance and quality controls
• Capacity for scalable production

Their strategic role involves supplying parsabiv API either directly or through partnerships, emphasizing quality and regulatory adherence.

2. Bachem

Bachem is a leading global provider of peptide APIs, with extensive infrastructure dedicated to complex peptide synthesis. Headquartered in Switzerland, Bachem maintains GMP manufacturing facilities worldwide, including production sites in Europe and North America.

Key Attributes:

• Wide portfolio of peptide APIs under GMP standards
• Deep expertise in peptide chemistry and process development
• Reliable supply chain with regulatory approvals in multiple jurisdictions

While primarily serving as a contract manufacturer, Bachem's reputation for product quality and compliance positions it as a preferred source for parsabiv API.

3. Zhejiang Medicine Co., Ltd

Zhejiang Medicine, based in China, has developed a comprehensive peptide API manufacturing platform, including APIs for indications in nephrology. Their capabilities align with producing peptide APIs such as etelcalcetide, supported by domestic regulations and international GMP certifications.

Key Attributes:

• Cost-effective manufacturing options
• Increasing GMP compliance for export markets
• Growing global presence in peptide API supply

Trade relationships and due diligence are essential when considering Zhejiang Medicine as a parsabiv API supplier.

4. WuXi AppTec

WuXi AppTec, a China-based integrated contract research and manufacturing organization (CRMO), offers peptide API manufacturing services aligning with international quality standards. Their facilities are GMP-certified, with capabilities spanning synthesis, purification, and quality control.

Key Attributes:

• End-to-end peptide API production
• Advanced analytical and quality assurance processes
• Global distribution network

WuXi AppTec's broad capabilities make it a viable sourcing option for parsabiv API.

5. Polypeptide Group

Based in the UK, the Polypeptide Group provides custom synthesis of peptides for both clinical and commercial applications. Their GMP facilities produce various peptide APIs, with experience in complex sequences.

Key Attributes:

• Specialized peptide synthesis expertise
• GMP-compliant manufacturing process
• Focus on therapeutic peptides

Their specialization positions them as a strategic partner for high-quality parsabiv API sourcing.

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Regional Considerations and Regulatory Compliance

Procurement of parsabiv API must adhere to regional regulatory standards. Manufacturers in North America and Europe typically maintain robust GMP certification aligned with FDA and EMA standards. Asian manufacturers, notably Chinese and Indian producers, offer cost advantages but require thorough due diligence regarding regulatory compliance and quality audits.

Cross-border sourcing entails evaluating import/export regulations, intellectual property protections, and supply chain resilience. Notably, geopolitical tensions and the COVID-19 pandemic have underscored the importance of diversified sourcing strategies.

Quality and Regulatory Standards

All credible parsabiv API sources must comply with GMP regulations, with documentation including batch records, stability data, and analytical testing results. Regulatory agencies like the FDA and EMA conduct inspections and audits to certify GMP adherence. Suppliers' ability to provide Certificates of Analysis (CoA), Quality Agreements, and validated analytical methods is critical.

Supply Chain Stability and Risk Management

Considering API manufacturing complexities, supply disruptions pose risks. As peptide synthesis involves multiple steps—solid-phase synthesis, purification, lyophilization—delays can occur due to raw material shortages, equipment failures, or regulatory non-compliance. Many pharmaceutical companies mitigate risks by establishing multiple supplier relationships or vertically integrating manufacturing.

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Emerging Trends in API Sourcing for Peptides

1. Contract Manufacturing Organizations (CMOs) Specialization

The trend toward outsourcing peptide API production to specialized CMOs is accelerating, driven by technological complexity and lower capital expenditure for companies. This facilitates access to advanced synthesis technologies and regulatory compliance support.

2. Geopolitical and Economic Shifts

Manufacturers are diversifying supply chains amid geopolitical uncertainties affecting China and other traditional markets. Digital transformation and increased transparency are shaping procurement strategies.

3. Advanced Manufacturing Technologies

Flow chemistry and automation are being integrated into peptide synthesis, promising enhanced quality, scalability, and cost reductions—beneficial for sourcing parsabiv API.

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Conclusion

The sourcing landscape for parsabiv API is characterized by a select group of specialized manufacturers, predominantly based in Europe, North America, and Asia, with a growing emphasis on quality, compliance, and supply chain resilience. Strategic partnerships and diligent supplier assessments are essential for procurement success.

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Key Takeaways

• Quality Assurance Is Paramount: Always verify GMP certification, regulatory compliance, and detailed quality documentation for parsabiv API suppliers.
• Diversification Reduces Risk: Engaging multiple reputable manufacturers across regions mitigates supply disruptions.
• Regulatory Compatibility Matters: Ensure suppliers meet regional standards (FDA, EMA, etc.) to streamline approval processes.
• Emerging Technologies Enhance Supply Chain Stability: Adoption of advanced peptide synthesis methods can improve scale and reduce costs.
• Strategic Partnerships Drive Long-Term Success: Building alliances with experienced CMOs ensures consistent quality and supply.

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FAQs

1. What are the key criteria for selecting a parsabiv API supplier?
Compliance with GMP, proven quality control measures, manufacturing capacity, track record in peptide synthesis, regulatory approvals, and supply chain reliability.

2. Are Chinese API manufacturers certified to supply global markets?
Many Chinese manufacturers have achieved GMP certification for exports, but due diligence on regulatory compliance and audit histories is essential.

3. How does peptide synthesis complexity impact API sourcing?
High complexity demands advanced technology, stringent quality controls, and experienced manufacturers; simpler synthesis routes typically facilitate procurement.

4. What are the regional regulatory challenges in sourcing peptide APIs?
Differences in GMP standards, import regulations, documentation requirements, and tariffs can affect sourcing strategies and timelines.

5. How is technological innovation transforming peptide API manufacture?
Flow chemistry, automation, and process optimization are enhancing scalability, reducing costs, and improving quality consistency.