Bulk Pharmaceutical API Sources for ANTRENYL

Bulk Pharmaceutical API Sources for ANTRENYL

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-000-735-345
Mcule		MCULE-1491988845
Glentham Life Sciences Ltd.		GL3388
Clearsynth		CS-O-02021
AKos Consulting & Solutions		AKOS030507607
LGC Standards		LGCFOR3175.00
LGC Standards		MM3175.00

Bulk Active Pharmaceutical Ingredient (API) Sources for: ANTRENYL (Ranolazine)

Last updated: July 30, 2025

Introduction

Antrenyl, commercially known as Ranolazine, is an anti-anginal medication primarily used to improve myocardial function in chronic angina. As with any pharmaceutical, the procurement of high-quality Active Pharmaceutical Ingredients (APIs) is critical for manufacturing efficacy, safety, and regulatory compliance. This detailed analysis explores the global landscape of bulk API sources for Ranolazine, emphasizing manufacturing regions, key suppliers, regulatory frameworks, and quality standards dictating sourcing choices.

Overview of Ranolazine API

Ranolazine’s API is a complex organic compound with a unique chemical structure characterized by a methoxy-substituted benzene ring linked to a substituted piperazine moiety. Its synthesis involves multiple chemical steps, including selective aromatic substitution and heterocyclic formation, which influence sourcing options significantly due to their complexity and purity requirements.

Global Production Hubs for Ranolazine API

1. India

India is a leading supplier of Ranolazine API, dominating the market with numerous API manufacturers specializing in cardiovascular drugs. Companies such as Cadila Healthcare, Sun Pharmaceutical Industries, and Laurus Labs offer high-quality Ranolazine API that meet international standards including USP, EP, and JP.

Advantages:

• Cost-efficiency due to lower manufacturing costs.
• Established GMP-compliant facilities and robust supply chains.
• Extensive experience in complex organic synthesis pertinent to Ranolazine.

Regulatory Considerations:

• Indian API suppliers often hold approvals from the U.S. FDA, EMA, and other global agencies, enabling seamless integration into international supply chains.

2. China

China hosts a significant cadre of API producers with capabilities in organic synthesis and chemical manufacturing. Several Chinese companies, such as Zhejiang Huahai Pharmaceutical and Shanghai Fosun Pharmaceutical, are known for producing Ranolazine API conforming to international quality standards.

Advantages:

• Large-scale production capacity.
• Competitive pricing.
• Rapid delivery timelines.

Quality and Regulatory Notes:

• Some Chinese suppliers have faced scrutiny for quality consistency; hence, rigorous audits and supplier qualification processes are critical.
• Increasing investments in regulatory compliance have improved the reliability of Chinese API suppliers.

3. United States and Europe

While the U.S. and European API manufacturers are relatively fewer in the domain of Ranolazine, some firms focus on high-purity APIs for niche or specialty markets. These suppliers often cater to clients requiring stringent quality standards, including cGMP compliance and advanced analytical validation.

Advantages:

• Superior quality control.
• Strong regulatory oversight.
• Often preferred for highly sensitive formulations or regulatory submissions.

Limitations:

• Higher procurement costs.
• Limited production capacity for Ranolazine compared to India and China.

Key API Manufacturers and Suppliers

Supplier	Location	Certification	Production Capacity	Notable Features
Cadila Healthcare	India	cGMP, FDA-approved	Large-scale	Cost-effective, reliable quality
Sun Pharmaceutical	India	cGMP, USFDA approved	Extensive	Integrated supply chain
Laurus Labs	India	cGMP	High-volume	Focus on complex APIs
Zhejiang Huahai Pharma	China	cGMP	Large-scale	Competitive pricing
Shanghai Fosun Pharma	China	cGMP	Substantial	Quality assurance

Regulatory and Quality Considerations in API Sourcing

For pharmaceuticals like Ranolazine, sourcing from suppliers with robust regulatory compliance frameworks reduces supply chain risks. Suppliers with existing certifications (e.g., USFDA, EMA, PMDA) provide assurance of adherence to Good Manufacturing Practices (GMP), raw material quality, and traceability.

Analytical testing and validation are vital; suppliers must provide comprehensive documentation, including:

• Certificates of Analysis (CoA).
• Material Safety Data Sheets (MSDS).
• Stability data.
• Residue and impurity testing reports.

Post-approval and ongoing quality audits are recommended to ensure consistent raw material quality.

Supply Chain Challenges and Considerations

Factors influencing sourcing decisions include:

• Supply continuity: Ensuring reliable supplier capacity and contingency planning.
• Lead time: Reducing delays with geographically proximal or well-established suppliers.
• Cost: Balancing budget constraints with quality requirements.
• Regulatory environment: Favoring suppliers with proven compliance records.
• Intellectual property (IP) rights: Verifying that APIs are produced legally and with respect to patents, where applicable.

Future Trends in API Sourcing for Ranolazine

Increasing regulatory scrutiny and emphasis on quality assurance are prompting a shift towards more diversified supply chains. Innovations in process optimization, such as continuous manufacturing, may influence future API sourcing strategies. Additionally, the trend toward regional manufacturing—particularly in North America and Europe—aims to mitigate geopolitical risks and enhance supply chain resilience.

Conclusion

The global API sourcing landscape for Ranolazine is mature, with India serving as the primary low-cost producer, supplemented by China’s large-scale manufacturing capabilities. High-quality suppliers in the U.S. and Europe serve niche markets emphasizing regulatory compliance and purity. Strategic procurement involves balancing cost, quality, regulatory acceptance, and supply stability to optimize manufacturing outcomes.

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Key Takeaways

• India and China dominate bulk Ranolazine API production, offering cost-effective solutions meeting international standards.
• Chinese suppliers are increasingly compliant with global regulations, though due diligence remains essential.
• Suppliers with FDA, EMA, or other regulatory approvals provide higher assurance of quality and compliance.
• Balancing cost-efficiency and quality is critical; manufacturers should audit API suppliers regularly.
• Diversification in API sourcing reduces supply chain risks amid geopolitical and regulatory fluctuations.

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FAQs

1. What are the main challenges in sourcing Ranolazine API globally?
Challenges include ensuring consistent quality, navigating differing regulatory standards, managing supply chain disruptions, and verifying supplier GMP compliance.

2. How does regulatory compliance impact API sourcing decisions for Ranolazine?
Regulatory compliance ensures safety and efficacy, facilitates faster approval processes, and minimizes legal risks, making suppliers with recognized certifications more attractive.

3. Are there emerging markets for Ranolazine API?
Yes, Southeast Asia and Eastern Europe are gradually developing capabilities, with some companies investing in high-quality manufacturing to meet global demands.

4. How do quality certifications influence supplier selection?
Certifications such as cGMP and approvals from agencies like the USFDA or EMA serve as indicators of quality control standards and regulatory adherence, critical for market acceptance.

5. Why is supply chain diversification important for Ranolazine API?
Diversification reduces dependency on a single supplier or country, mitigating risks related to geopolitical issues, regulatory changes, and supply disruptions.

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References

[1] US Pharmacopeia, Ranolazine Monograph.
[2] European Pharmacopoeia, Ranolazine Standards.
[3] Market Intelligence Reports on API Manufacturing, 2022.
[4] Regulatory Guidelines for API Inspection, FDA and EMA.
[5] Industry analyses on Asian API manufacturing capabilities.