AMLODIPINE BENZOATE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340	NDA	Azurity Pharmaceuticals, Inc.	52652-5001-1	1 BOTTLE in 1 CARTON (52652-5001-1) / 150 mL in 1 BOTTLE	2019-08-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

Amlodipine benzoate, a pharmaceutical compound used primarily to manage hypertension and angina, is a derivative of amlodipine with a benzoate ester component. Its widespread use necessitates a reliable supply chain comprising reputable manufacturers and suppliers. This article details the key suppliers, the manufacturing landscape, and strategic considerations for stakeholders seeking to source amlodipine benzoate efficiently and compliantly.

Overview of Amlodipine Benzonate Production

Amlodipine benzoate is produced through complex chemical synthesis, involving the esterification of amlodipine with benzoic acid derivatives. The pharmaceutical-grade compound must meet stringent regulatory standards, including Good Manufacturing Practices (GMP), ensuring quality, potency, purity, and stability [1].

The supply chain for amlodipine benzoate is characterized by a combination of large multinational pharmaceutical manufacturers, specialized intermediates suppliers, and chemical manufacturers that produce the active pharmaceutical ingredients (APIs) and excipients.

Leading Suppliers and Manufacturers

1. Major Global API Manufacturers

Several well-established pharmaceutical ingredient producers manufacture amlodipine and its derivatives, including amlodipine benzoate. These companies typically operate facilities compliant with international standards such as GMP, ISO, and EDQM certifications.

Sun Pharmaceutical Industries Ltd.
Sun Pharma supplies amlodipine besylate and related compounds to the global market, with some capacity for derivative manufacturing depending on regional compliance laws [2].
Mylan (now part of Viatris)
Viatris' predecessor Mylan is known for producing high-quality cardiovascular APIs, including variants of amlodipine, with extensive distribution networks.
Zhejiang Huahai Pharmaceutical Co., Ltd.
A Chinese pharmaceutical manufacturer with significant API production capacities, including calcium channel blockers like amlodipine. Their products are widely exported and often used as raw materials for further formulation [3].
Hetero Labs Limited
An Indian pharmaceutical company specializing in active ingredients and intermediates, including amlodipine derivatives. Hetero emphasizes GMP compliance and a robust global supply chain.

2. Specialized Chemical Suppliers of Amlodipine Intermediates

Glenmark Pharmaceuticals
Glenmark manufactures both finished APIs and intermediates with facilities certified by global regulators, providing a pathway for sourcing amlodipine intermediates needed for bespoke formulations.
CordenPharma
A subsidiary of International Chemical Investors Group, CordenPharma supplies pharmaceutical intermediates and APIs, including tailored amlodipine formulations, to contract manufacturing organizations (CMOs).
Apotex Inc.
A Canadian generic pharmaceutical company that produces amlodipine and offers intermediates for custom synthesis, with an emphasis on regulatory compliance.

Regional Considerations and Vendor Reliability

Asia-Pacific Region: Dominant producer of raw materials, notably China and India, contributing over 70% of global API manufacturing capacity [4]. While cost-effective, regulatory variability necessitates diligence in validating supplier GMP compliance.
Europe and North America: Smaller market share but higher regulatory oversight ensures higher quality standards. Suppliers from these regions often serve niche markets or provide high-grade certifications necessary for strict markets.
Emerging Markets: Countries like Turkey, Brazil, and South Africa increasingly develop local API manufacturing facilities, diversifying the supply base, albeit with variable regulatory compliance.

Supply Chain Challenges and Strategic Sourcing

Regulatory Variability: Ensuring supplier GMP compliance and documentation is critical to mitigate quality assurance risks and ensure regulatory submissions are unimpeded.
Intellectual Property and Patent Considerations: Amlodipine's patent protection, which expired in many jurisdictions around 2012, has resulted in increased generic availability, expanding supplier options. However, some formulations like amlodipine benzoate may still be under patent constraints depending on region.
Manufacturing Capacity and Lead Times: Fluctuations in API demand, especially during pandemics or supply chain disruptions, can impact availability. Strategic inventory management and multi-supplier sourcing are recommended.
Price and Quality Balance: While low-cost suppliers from China and India dominate, extensive due diligence is essential to verify quality, regulatory registration, and compliance.

Regulatory and Quality Considerations

Sourcing from certified suppliers adhering to pharmacopeial standards (USP, EP, JP) ensures the API meets quality parameters. Validation of supply chain integrity, batch documentation, and independent testing are vital steps before procurement [5].

Emerging Trends and Future Outlook

Increased Localization: Governments and pharmaceutical companies are investing in local API manufacturing capabilities to reduce dependency on overseas sources and mitigate geopolitical risks.
Technological Innovations: Advancements in green chemistry and process optimization are enabling more sustainable and cost-effective production of amlodipine derivatives.
Regulatory Harmonization Efforts: Enhanced mutual recognition agreements and global harmonization initiatives streamline supplier qualification processes.

Conclusion

Reliable supply of amlodipine benzoate hinges on sourcing from established, GMP-compliant manufacturers with proven regulatory track records. While regional variations exist, the global landscape is characterized by a broad array of qualified suppliers across Asia, Europe, and North America. Strategic supplier selection, rigorous quality assessment, and proactive supply chain management underpin successful procurement outcomes for pharmaceutical manufacturers and generic drug developers.

Key Takeaways

Major suppliers include leading API manufacturers such as Sun Pharma, Mylan (Viatris), Zhejiang Huahai, and Hetero Labs, who offer high-quality amlodipine intermediates and APIs.
Asia-Pacific remains the dominant manufacturing hub, offering cost advantages but requiring diligent quality verification.
Regulatory compliance, GMP certification, and quality assurance are paramount when selecting suppliers for pharmaceutical-grade amlodipine benzoate.
Diversification of sourcing strategies mitigates supply chain risks amid geopolitical, logistical, and regulatory uncertainties.
Emerging local manufacturing initiatives aim to reduce dependency on overseas suppliers and enhance supply resilience.

FAQs

1. Is it possible to source pharmaceutical-grade amlodipine benzoate directly from Chinese manufacturers?
Yes, several Chinese manufacturers, such as Zhejiang Huahai Pharmaceutical, produce GMP-compliant amlodipine APIs, including derivatives like amlodipine benzoate. Buyers must ensure rigorous verification of GMP certificates, quality control processes, and regulatory compliance before procurement.

2. What challenges are associated with sourcing from Indian API producers?
Indian API suppliers like Hetero Labs and Natco Pharma are known for quality and cost competitiveness. Challenges may include regulatory certification processes, documentation, and supply chain transparency, which necessitate thorough vendor audits.

3. How can I validate the quality of amlodipine benzoate from new suppliers?
Conduct comprehensive supplier audits, request GMP certificates and batch documentation, review inspection reports, and perform independent laboratory testing of initial batches prior to full-scale procurement.

4. Are there regional differences influencing API quality for amlodipine benzoate?
Yes. European and North American suppliers tend to have stricter regulatory oversight and higher quality standards. Asian suppliers offer cost advantages but require verification of compliance with local and international standards.

5. What future trends will influence the supply chain for amlodipine benzoate?
Increasing localization of API manufacturing, technological process improvements, and global harmonization of regulatory standards aim to enhance supply chain resilience, quality, and sustainability for amlodipine benzoate.

References

World Health Organization. (2020). Guidelines on Good Manufacturing Practices (GMP) for Pharmaceutical Products.
Sun Pharmaceutical Industries Ltd. Annual Reports and Product Catalogs.
Zhejiang Huahai Pharmaceutical Co., Ltd. Certifications and Compliance Data.
United Nations Conference on Trade and Development (UNCTAD). (2021). World Investment Report.
FDA and EMA guidelines on active pharmaceutical ingredient sourcing and quality assurance.

Suppliers and packagers for generic pharmaceutical drug: AMLODIPINE BENZOATE