Bulk Pharmaceutical API Sources for amlodipine benzoate

Bulk Pharmaceutical API Sources for amlodipine benzoate

Vendor	Vendor Homepage	Vendor Sku	API Url
BOC Sciences		1239916-29-0
BenchChem		B1437191
THE BioTek		bt-1726529
Smolecule		S888079
CymitQuimica		CQ_1239916-29-0
AA BLOCKS		AA024PRC

Bulk Active Pharmaceutical Ingredient (API) Sources for: Amlodipine Benzoate

Last updated: August 2, 2025

Introduction

Amlodipine benzoate, a calcium channel blocker, is widely prescribed for hypertension and angina pectoris. Its efficacy hinges on manufacturing quality, making the selection of reliable API sources critical for pharmaceutical companies. As global demand for Amlodipine benzoate surges, understanding the landscape of bulk API suppliers becomes indispensable for ensuring compliance, cost-efficiency, and consistent drug quality.

This report evaluates key suppliers of Amlodipine benzoate API, encompassing their geographic distribution, regulatory compliance, production capacity, and quality assurance protocols. The goal: empower industry professionals to optimize sourcing strategies amidst evolving pharmaceutical standards.

Global API Manufacturing Landscape for Amlodipine Benzoate

Major Manufacturing Regions

The production of Amlodipine benzoate API is concentrated in regions with robust pharmaceutical manufacturing infrastructure, primarily:

• India: Leading the market due to high-volume API manufacturing coupled with competitive pricing. Indian suppliers often possess extensive experience, established Good Manufacturing Practices (GMP), and regulatory approvals for exports.

• China: A significant hub for pharmaceutical intermediates and APIs, offering large-scale manufacturing capabilities. Many Chinese API manufacturers invest heavily in technological innovation and compliance.

• Europe and the United States: While fewer in number, these regions host some of the most tightly regulated API producers, often serving premium markets or companies requiring stringent quality assurance.

Key Suppliers and Manufacturers

Indian API Producers

1. HIKAL Ltd.
   Overview: One of India's prominent API manufacturers with a comprehensive portfolio. Known for high-quality manufacturing adhering to cGMP standards.
   Certifications: ISO 9001, USFDA, EU-GMP.
   Production Capacity: Several metric tons annually, capable of fulfilling large-volume orders.
   Notes: Recognized for reliable supply chains and quality consistency.

2. Srushti Pharmaceuticals
   Overview: Focused on cost-effective manufacturing with FSC-relevant certifications.
   Certifications: ISO, DGQA.
   Notes: Good choice for companies seeking balance between quality and affordability.

3. Abbot India Ltd.
   Overview: A major player with extensive API manufacturing facilities compliant with international standards.
   Certifications: USFDA approved.
   Notes: Serves global markets with a broad regulatory acceptance.

Chinese API Producers

1. Zhejiang Huafeng Pharmaceutical Co., Ltd.
   Overview: Offers large-scale API synthesis capabilities.
   Certifications: ISO, cGMP.
   Notes: Strong in meeting bulk supply demands for generic pharmaceuticals.

2. Shandong Xinhua Pharmaceutical Co., Ltd.
   Overview: Well-established with global export licenses.
   Certifications: GMP, ISO.
   Notes: Known for aggressive pricing and decent quality standards.

3. Qingdao Bega Biotechnology Co., Ltd.
   Overview: Focused on high-purity intermediates and APIs with advanced synthesis processes.
   Notes: Often supplies specialty grades suitable for complex formulations.

European and US Suppliers

Limited compared to Indian and Chinese counterparts but critical for high-quality, high-purity APIs suitable for ultra-sensitive or regulated markets.

1. Hexal (Germany)
   Overview: Part of the Novartis group, known for meticulously regulated APIs.
   Certifications: EU-GMP, FDA.
   Notes: Higher costs but superior quality and regulatory compliance.

2. Pfizer (US)
   Overview: Major producer with global supply chain robustness.
   Notes: API may be supplied via authorized partners or licensees.

Emerging Suppliers and Contract Manufacturing Organizations (CMOs)

Several CMOs globally are expanding their portfolios to include Amlodipine benzoate, offering flexibility, scalable production, and strategic sourcing options.

• Lonza (Switzerland): Known for high standards in API manufacturing, including complex molecules.
• Liya Pharma (India): Focused on cost-competitive APIs with regulatory approvals.
• Fujifilm Diosynth Biotechnologies (Japan): Primarily biopharmaceuticals but expanding into small molecule APIs.

Regulatory Considerations

Sourcing APIs, especially for life-saving medications, necessitates strict adherence to regulatory guidelines. Suppliers with USFDA, EMA, or WHO GMP certifications provide assurance of quality, traceability, and compliance. Regulatory agencies frequently conduct audits, and non-compliance can lead to supply disruptions and market access issues.

Companies should verify the authenticity of certifications and conduct due diligence, including site audits where feasible. Given the complexity of the supply chain, establishing clear quality agreements and qualification protocols is paramount.

Quality Assurance and Due Diligence

• Analytical validation: Confirm API purity, potency, and residual solvents through batch testing reports.
• Stability data: Request stability study reports aligning with pharmacopoeial standards.
• Traceability: Ensure batch records, Certificate of Analysis (CoA), and manufacturing licenses are verifiable and current.
• Supply reliability: Evaluate the supplier’s production capacity, lead times, and contingency plans.

Cost Considerations

Price remains an influential factor. Indian and Chinese suppliers typically offer lower costs, with Indian sources often providing better regulatory acceptance for Western markets. Nevertheless, companies must balance cost with quality, regulatory risk, and supply chain stability.

Future Trends in API Sourcing for Amlodipine Benzoate

• Localization and Diversification: Companies are diversifying suppliers to mitigate geopolitical and supply chain risks.
• Regulatory Stringency: Increasing emphasis on certifications and audits to maintain compliance.
• Innovation in Manufacturing: Adoption of continuous manufacturing and green chemistry practices to enhance sustainability and efficiency.
• Digital Platforms: Growing reliance on digital procurement platforms for transparency and traceability.

Key Takeaways

• India and China dominate the global API market for Amlodipine benzoate, with a range of suppliers offering competitive pricing and scalable capacity.
• Regulatory compliance, especially GMP certification from recognized authorities, remains the cornerstone of choosing an API supplier.
• Due diligence, including certification validation, analytical testing, and supply chain assessment, is critical to mitigate risks.
• High-quality European and US suppliers, though more costly, offer stringent quality assurance suitable for highly sensitive markets.
• Companies should consider diversification, technological advancements, and real-time supply chain monitoring to enhance resilience.

FAQs

1. What are the top considerations when sourcing Amlodipine benzoate API?
Quality certification (GMP compliance), regulatory approval, manufacturing capacity, price, and supply reliability.

2. How do Indian and Chinese API suppliers compare regarding quality?
Indian suppliers often meet international standards like USFDA or EU-GMP, whereas Chinese suppliers vary; thorough validation and audits are advisable before procurement.

3. Are there environmentally sustainable options in API manufacturing?
Emerging suppliers are adopting green chemistry practices, reducing solvents, and minimizing waste, aligning with sustainability initiatives.

4. How can suppliers verify the authenticity of their API products?
By requesting detailed Certificates of Analysis, batch records, regulatory certifications, and conducting audits where necessary.

5. Is it advisable to use multiple API sources for Amlodipine benzoate?
Yes, diversification reduces supply chain risks but requires strict validation and quality management to maintain consistent drug quality.

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References

1. Drug Master Files and regulatory filings for Amlodipine API, U.S. Food and Drug Administration (FDA).
2. API supplier profiles and certifications, official websites of HIKAL Ltd., Zhejiang Huafeng Pharmaceutical, and others.
3. Global API manufacturing trends, IQVIA Reports, 2022.
4. International Pharmacopoeias and GMP guidelines, WHO, EMA, and FDA publications.