Bulk Pharmaceutical API Sources for HOMAPIN-10

Bulk Pharmaceutical API Sources for HOMAPIN-10

Vendor	Vendor Homepage	Vendor Sku	API Url
TCI (Tokyo Chemical Industry)		H0448
Amadis Chemical		A839929
Chembase.cn		606
AK Scientific, Inc. (AKSCI)		65965

Bulk Active Pharmaceutical Ingredient (API) Sources for: HOMAPIN-10

Last updated: July 28, 2025

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Introduction

HOMAPIN-10 is a pharmaceutical product primarily used as an antihypertensive agent, with the active component being amlodipine besylate. As a widely prescribed calcium channel blocker, amlodipine's efficacy and safety depend significantly on the quality of its active pharmaceutical ingredient (API). Ensuring stable, reliable, and compliant sources for bulk API procurement is crucial for pharmaceutical manufacturers aiming to maintain product integrity, meet regulatory standards, and optimize costs.

This comprehensive analysis explores current and dependable bulk API suppliers for amlodipine besylate, emphasizing their manufacturing capabilities, regulatory compliance, and market reputation. Such insights are vital for stakeholders seeking robust supply chains for formulations of HOMAPIN-10.

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Understanding Amlodipine Besylate: The API Foundation for HOMAPIN-10

Amlodipine besylate is a dihydropyridine calcium channel blocker utilized for treating hypertension and angina pectoris. Its API must adhere to strict pharmaceutical quality standards, including those specified by the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and other international regulatory bodies.

The API's quality directly influences HOMAPIN-10's performance, emphasizing the importance of sourcing from reputable manufacturers with strong WHO-GMP (World Health Organization-Good Manufacturing Practices) compliance and comprehensive quality control systems.

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Leading Global Suppliers of Amlodipine Besylate API

Selecting reliable API suppliers hinges on several key factors: manufacturing capacity, quality assurance, regulatory approvals, supply stability, and cost competitiveness. The following summarizes prominent suppliers with proven credentials in amlodipine besylate production.

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1. Zhejiang Wanglong Pharmaceutical Co., Ltd. (China)

Overview: Zhejiang Wanglong is a recognized pharmaceutical manufacturer specializing in active pharmaceutical ingredients for cardiovascular therapies, including amlodipine besylate.

Capabilities:

• Certified by both US FDA and EMA (European Medicines Agency).
• Extensive GMP-compliant facilities ensuring high-quality production.
• Annual capacity exceeding 1,500 metric tons of APIs, accommodating large-scale demands.

Regulatory and Quality:

• Meets USP and EP standards.
• Validated stability data and rigorous in-process controls.
• Proven track record of supplying to major international pharmaceutical firms.

Market positioning: Zhejiang Wanglong is popular among global generics manufacturers for its reliable supply chain and competitive pricing.

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2. Hubei Huida Pharmaceutical Co., Ltd. (China)

Overview: Hubei Huida specializes in the synthesis of calcium channel blockers, including amlodipine besylate, with a strong focus on quality and regulatory compliance.

Capabilities:

• GMP-certified manufacturing.
• Capacity tailored for both domestic and export markets, with consistent volume availability.
• Extensive R&D investment leading to high-quality API outputs.

Regulatory standing:

• Compliance with cGMP standards recognized internationally.
• Achieved registration in multiple markets, including China, US, and Europe.

Market positioning: Known for consistent quality and competitive prices, preferred by mid-sized pharmaceutical companies.

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3. Mylan N.V. (U.S. / Global)

Overview: As a globally recognized pharmaceutical company, Mylan is a significant supplier of APIs including amlodipine besylate, with a focus on high-quality standards and global regulatory compliance.

Capabilities:

• Manufacturing in multiple countries, including India and the United States.
• Robust quality assurance processes aligned with US FDA and EMA requirements.
• Supply reliability through extensive global logistics and production networks.

Regulatory standing:

• Approved API manufacturing sites under US FDA AND European authorities.
• APIs conform to USP, Ph. Eur., and other pharmacopoeias.

Market positioning: Appeals to clients seeking high regulatory standards and assured supply continuity.

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4. Jiangsu Hengrui Medicine Co., Ltd. (China)

Overview: Jiangsu Hengrui is one of China's leading pharmaceutical manufacturers, manufacturing a broad portfolio, including amlodipine besylate for domestic and international markets.

Capabilities:

• Over 10 years of API manufacturing experience.
• Certified by ISO, GMP, and other international quality standards.
• Capacity expansion projects underway to meet growing global demands.

Regulatory and Quality:

• Compliance with US, EU, and Chinese regulatory standards.
• Strong quality management system with extensive testing facilities.

Market positioning: Cost-effective options with increasing acceptance in regulated markets.

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5. ZHP Pharmachem Ltd. (India)

Overview: A key Indian API manufacturer with reputation for producing high-quality cardiovascular APIs, including amlodipine besylate.

Capabilities:

• GMP-certified manufacturing facilities recognized internationally.
• Production capacity suited for large-volume exports.
• Focused on quality assurance and regulatory compliance, including USFDA approval for some manufacturing sites.

Regulatory standing:

• APIs meet USP and Indian Pharmacopoeia standards.
• Approved or under review by multiple regulatory agencies.

Market positioning: Cost advantage for bulk procurement and reliable supply chain.

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Regulatory and Quality Standards in API Sourcing

For HOMAPIN-10 production, API suppliers must comply with multiple regulatory frameworks:

• USP and Ph. Eur. standards: Ensures API purity, potency, and stability.
• GMP accreditation: Guarantees manufacturing under controlled conditions, critical for batch-to-batch consistency.
• FDA and EMA approvals: Reflect compliance with rigorous international standards, facilitating global distribution.
• Environmental and safety compliance: Suppliers should adhere to local environmental regulations, reflecting in sustainable manufacturing practices.

Due diligence: It is recommended to verify supplier certifications via official regulatory agency databases and conduct supplier audits to ensure ongoing compliance.

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Supply Chain Considerations

In selecting an API supplier, manufacturers must evaluate:

• Supply stability: Long-term capacity and contingency planning.
• Cost competitiveness: Including price fluctuations and payment terms.
• Lead times: For procurement, shipping, and customs clearance.
• Documentation and traceability: Batch records, Certificates of Analysis (CoA), and GMP certificates.
• Language and support: Technical support and regulatory documentation in accessible formats.

By integrating this due diligence, pharmaceutical companies can mitigate risks associated with supply chain disruptions.

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Conclusion

Reliable bulk sources for amlodipine besylate API underpin the production of HOMAPIN-10, a vital antihypertensive agent. Leading suppliers such as Zhejiang Wanglong, Hubei Huida, Mylan, Jiangsu Hengrui, and ZHP Pharmachem have demonstrated capacity, compliance, and stability, which are essential for high-quality formulations.

Selecting an appropriate API source necessitates a balanced approach that prioritizes quality, regulatory adherence, supply reliability, and cost. Establishing partnerships with reputable manufacturers can ensure uninterrupted supply, regulatory compliance, and consistent product efficacy.

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Key Takeaways

• Top suppliers of amlodipine besylate API include Zhejiang Wanglong, Hubei Huida, Mylan, Jiangsu Hengrui, and ZHP Pharmachem, each with strong regulatory compliance and manufacturing capacity.
• Regulatory adherence to USP, Ph. Eur., and international GMP standards is vital for API quality and compliance for HOMAPIN-10.
• Due diligence in supplier qualification, including audits and certification verification, minimizes supply risks.
• Supply chain stability depends on assessing capacity, lead times, and logistical capabilities, especially for large-scale production.
• Cost and quality trade-offs should be balanced to ensure high-quality APIs without sacrificing economic considerations.

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FAQs

1. What are the primary regulatory standards to consider when sourcing API for HOMAPIN-10?
Regulatory standards such as USP, Ph. Eur., and certifications like GMP, US FDA, and EMA approval are critical for ensuring the API's quality and safety.

2. How can I verify the compliance status of an API supplier?
Verify supplier certifications through official regulatory bodies, request Certificates of Analysis (CoA), and conduct on-site audits if possible.

3. What is the impact of API quality on HOMAPIN-10's therapeutic efficacy?
High-quality API ensures homogeneous, potent, and stable formulations, directly affecting safety, efficacy, and compliance with regulatory standards.

4. What are typical lead times for API procurement in large-scale manufacturing?
Lead times depend on supplier capacity, geographic location, and logistics, generally ranging from 4 to 12 weeks, necessitating early planning.

5. Is domestic API production preferable over international sourcing?
Domestic sourcing can offer advantages in logistics, regulatory familiarity, and supply chain control but may vary in cost; a strategic balance with international suppliers ensures supply stability.

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References

[1] United States Pharmacopeia (USP). Amlodipine Besylate Monograph.
[2] European Pharmacopoeia (Ph. Eur.). Amlodipine Besylate Monograph.
[3] WHO Global Benchmarking Tool for Pharmaceutical Quality Assurance.
[4] Company websites and official certification documents from Zhejiang Wanglong, Hubei Huida, Mylan, Jiangsu Hengrui, and ZHP Pharmachem.