Bulk Pharmaceutical API Sources for cinacalcet hydrochloride

Bulk Pharmaceutical API Sources for cinacalcet hydrochloride

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-1799
Molport		MolPort-006-393-290
AKos Consulting & Solutions		AKOS005146514
Amadis Chemical		A823266
Oakwood Products		079280
BioChemPartner		BCPP000409

Bulk Active Pharmaceutical Ingredient (API) Sources for CINACALCET HYDROCHLORIDE

Last updated: August 2, 2025

Introduction

Cinacalcet Hydrochloride is a calcimimetic agent principally designed to modulate the parathyroid hormone (PTH) secretion in patients with secondary hyperparathyroidism associated with chronic kidney disease or parathyroid carcinoma. As an essential component in the treatment regimen, its manufacturing relies heavily on high-quality bulk Active Pharmaceutical Ingredients (APIs). Identifying reputable sources for Cinacalcet Hydrochloride is vital for pharmaceutical companies, ensuring regulatory compliance, quality assurance, and uninterrupted supply chains.

Overview of Cinacalcet Hydrochloride

Approved by the FDA in 2004, Cinacalcet Hydrochloride’s chemical formula is C20H22N2O4S·HCl, with a molecular weight of approximately 469.9 g/mol. The API exhibits complex synthesis pathways involving multiple steps that necessitate stringent process controls. Given its critical therapeutic application, sourcing APIs that meet pharmacopoeial standards—such as USP, EP, or JP—is non-negotiable for manufacturers.

Key Criteria for API Source Selection

When evaluating sources of Cinacalcet Hydrochloride, several factors should guide procurement decisions:

• Regulatory Compliance: Certificates of Analysis (CoA), Good Manufacturing Practice (GMP) certification, and adherence to international pharmacopoeial standards.
• Quality Assurance: Purity (>99%), low residual solvents and heavy metals, stability, and consistent batch-to-batch quality.
• Supply Reliability: Proven track record of timely delivery, large batch capacities, and robust logistics.
• Cost-effectiveness: Competitive pricing without compromising quality.
• Traceability: Full transparency of manufacturing processes and origin.

Global API Manufacturers for Cinacalcet Hydrochloride

1. Teva Pharmaceutical Industries Ltd.

Teva is a leading generic pharmaceutical manufacturer with a robust portfolio of APIs, including Cinacalcet Hydrochloride. Their facilities are GMP-certified and compliant with international regulatory standards. Teva’s significant capacity and global distribution network make it a top choice for pharmaceutical companies seeking reliable API supply.

2. Mylan (a Viatris company)

Viatris, formed by the merger of Mylan and Pfizer’s generics division, offers Cinacalcet Hydrochloride sourced through its extensive manufacturing footprint. They maintain strict quality controls aligned with global standards, ensuring high-purity APIs suitable for commercial production.

3. Zhejiang Hisun Pharmaceutical Co., Ltd.

Based in China, Hisun Pharmaceutical is a prominent manufacturer of active pharmaceutical ingredients, including Cinacalcet Hydrochloride. The company holds several GMP certifications and supplies to multiple continents. Their API production facilities are equipped with advanced synthesis technology, supporting consistent quality.

4. Jiangsu Hengrui Medicine Co., Ltd.

Jiangsu Hengrui is another China-based pharmaceutical company with a growing reputation for high-quality APIs. Their manufacturing process complies with GMP standards, and they have multiple international certifications. They are known for competitive pricing and reliable supply.

5. Aurobindo Pharma Ltd.

Indian pharmaceutical titan Aurobindo manufactures a variety of APIs, including Cinacalcet Hydrochloride. Their quality management system ensures GMP compliance, and they cater to both domestic and international markets with a focus on cost-effective solutions.

Regional API Suppliers and Considerations

India

India dominates global API manufacturing, with companies such as Aurobindo, Dr. Reddy's Laboratories, and Hetero Drugs. Their APIs often meet global quality standards, supported by compliance with regulatory agencies such as the US FDA, EMA, and WHO prequalification programs.

China

Chinese APIs are widely available owing to the country’s extensive manufacturing infrastructure. Manufacturers like Zhejiang Hisun and Hengrui are reputable sources, but due diligence on regulatory compliance and quality standards remains essential for overseas buyers.

Europe and North America

Limited local sources exist due to scale and cost factors; most pharmaceutical companies rely on established Asian manufacturers or specialized European suppliers to access high-quality APIs for specific compounds like Cinacalcet.

Challenges and Risk Management

• Regulatory Variability: Variations in quality and compliance standards across regions demand rigorous supplier qualification.
• Supply Disruptions: Political or logistical issues can impact raw material flow; establishing multiple supplier relationships mitigates this risk.
• Counterfeit APIs: The proliferation of substandard or counterfeit APIs necessitates careful vendor vetting, audits, and verification of certificates.
• Price Fluctuations: Market dynamics influence API pricing; long-term contracts and volume commitments can stabilize costs.

Regulatory and Quality Control Considerations

Manufacturers should mandate comprehensive documentation, including:

• GMP certification copies.
• Certificates of Analysis specifying assay, residual solvents, heavy metals, and microbial limits.
• Stability data aligned with ICH guidelines.
• Documentation of process validation.

Before procurement, conducting vendor audits and qualification batches ensures compliance with Good Manufacturing Practices and consistent API quality.

Emerging Trends in API Sourcing

Advancements in manufacturing technologies, such as continuous synthesis and green chemistry, are poised to refine API quality and supply stability. Moreover, partnerships between multinational pharmaceutical firms and regional API manufacturers aim to diversify supply sources and bolster resilience against disruptions.

Conclusion

Reliable sourcing of Cinacalcet Hydrochloride API rests on a comprehensive assessment of quality, compliance, supply reliability, and cost-effectiveness. Leading global manufacturers like Teva, Mylan, Hisun, Jiangsu Hengrui, and Aurobindo offer high-grade APIs meeting international standards. As the demand for Cinacalcet remains strong, strategic procurement decisions underpinned by rigorous qualification processes are crucial to maintaining product integrity and supply chain stability.

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Key Takeaways

• Prioritize GMP-certified manufacturers with robust quality assurance processes for sourcing Cinacalcet Hydrochloride.
• Asian manufacturers, notably from China and India, dominate the API supply landscape due to scale, cost, and technological capabilities.
• Maintain diverse supplier relationships to mitigate risks associated with geopolitical, logistical, or regulatory disruptions.
• Conduct thorough audits and validate supplier documentation before procurement.
• Stay updated on emerging manufacturing innovations that can enhance API quality and supply resilience.

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FAQs

Q1: What are the primary regions supplying high-quality Cinacalcet Hydrochloride API?
A: Leading API suppliers are predominantly based in India and China, with notable manufacturers including Aurobindo, Hengrui, Zhejiang Hisun, Teva, and Mylan, all conforming to international GMP standards.

Q2: How can buyers ensure the quality of Cinacalcet Hydrochloride APIs?
A: Buyers should verify Certificates of Analysis, conduct vendor audits, review GMP certifications, and validate manufacturing processes to ensure APIs meet pharmacopoeial standards and specifications.

Q3: What risk factors should be considered when sourcing APIs from China?
A: Risks include regulatory variability, potential quality inconsistencies, and supply chain disruptions. Due diligence, supplier audits, and maintaining multiple vendor relationships help mitigate these issues.

Q4: Are there alternative sources for Cinacalcet Hydrochloride API outside Asia?
A: Yes, European and North American manufacturers supply APIs, though they are less common due to higher costs and limited production capacity. Regional suppliers should also meet strict compliance standards.

Q5: What trends are shaping the future of API sourcing for drugs like Cinacalcet?
A: Trends include adoption of green synthesis technologies for cleaner production, increased regional manufacturing to diversify supply chains, and stricter regulatory oversight to ensure quality and safety.

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References:

1. U.S. Food and Drug Administration. FDA Approved Drugs.
2. European Pharmacopoeia. Standards for APIs.
3. Pharmacopoeial Forum. Guidelines on API quality.
4. Company websites and press releases of Teva, Mylan, Hisun, Hengrui, and Aurobindo.
5. Industry reports on global API manufacturing trends.