Bulk Pharmaceutical API Sources for AMICAR

Bulk Pharmaceutical API Sources for AMICAR

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		A7824_SIGMA
Sigma-Aldrich		A2504_SIGMA
Vitas-M Laboratory		STK246894
TCI (Tokyo Chemical Industry)		A2255
TCI (Tokyo Chemical Industry)		A0312
Molport		MolPort-001-779-881
Hangzhou APIChem Technology		AC-035

Bulk Active Pharmaceutical Ingredient (API) Sources for AMICAR

Last updated: July 30, 2025

Introduction

Amicar, chemically known as ethamsylate, is a hemostatic agent primarily used to control bleeding episodes associated with surgical procedures, heavy menstruation, or trauma. As an essential drug, the sourcing of high-quality Active Pharmaceutical Ingredient (API) for Amicar is critical for pharmaceutical manufacturers, regulators, and healthcare providers. Reliable API suppliers ensure drug safety, efficacy, and regulatory compliance. This article explores the global landscape of bulk API sources for Amicar, emphasizing key manufacturers, geographic distribution, quality standards, and procurement considerations.

Understanding Ethamsylate (Amicar) API

Ethamsylate, marketed under the trade name Amicar, functions as a hemorrheologic agent, promoting platelet aggregation and capillary stabilization. Due to its vital role in managing bleeding, a consistent and reputable source of high-quality API is vital. The synthesis of ethamsylate involves complex chemical reactions requiring stringent quality controls to meet pharmacopeial standards (e.g., USP, EP, or JP).

Global API Manufacturing Regions

Several regions dominate the API manufacturing landscape due to their established pharmaceutical infrastructure, regulatory frameworks, and production capacities:

China

China remains a leading global API producer, accounting for a significant share of the world's pharmaceutical raw materials. Chinese manufacturers benefit from economies of scale, comprehensive supply chains, and governmental support. Major Chinese API producers for ethamsylate include:

• Hefei Bomei Biotech Co., Ltd.
• Shenzhen Zhenyang Pharmaceutical Co., Ltd.
• Jiangxi Microcore Pharmaceutical Co., Ltd.

These producers meet stringent regulatory requirements, often obtaining certifications such as GMP (Good Manufacturing Practice) to export globally.

India

India's pharmaceutical sector boasts an extensive API manufacturing base, driven by affordable labor, robust R&D, and a proactive regulatory environment (e.g., CDSCO). Indian companies producing ethamsylate APIs include:

• Divi's Laboratories
• Aurobindo Pharma
• Granules India

Indian API manufacturers comply with international standards, including WHO-GMP and US FDA approvals, facilitating exports to North America, Europe, and emerging markets.

European Union

While Europe predominantly focuses on formulation development and finished dosage forms, a few specialized API manufacturers operate under stringent EU-GMP standards:

• BASF SE (Germany)
• Evonik Industries (Germany)
• Wockhardt (UK)

European API sources generally cater to high-value, regulated markets, emphasizing compliance, purity, and sustainability.

United States

The U.S. market relies heavily on imports for API sourcing, including ethamsylate, due to centralized regulation and market size. While the US has limited domestic APIs for ethamsylate, some U.S.-based firms with manufacturing facilities in other regions include:

• Amneal Pharmaceuticals
• Pharmaceutical researchers with API production facilities licensed under FDA standards

Other Notable Regions

• South Korea and Japan possess advanced pharmaceutical manufacturing capabilities for quality APIs, although their focus often centers on high-end, specialty APIs.

Criteria for Selecting API Suppliers

When sourcing API for Amicar, pharmaceutical companies must evaluate suppliers on multiple parameters:

Regulatory Compliance

Suppliers should have GMP certification and other relevant approvals (e.g., ISO, WHO-GMP, US FDA). Regulatory compliance ensures product consistency, purity, and safety.

Quality Standards

High-quality APIs must meet pharmacopeial standards, including assay purity, residual solvents, heavy metals testing, and microbial limits. Certificates of analysis (CoA) and batch documentation are crucial.

Supply Capacity and Reliability

Consistent supply and lead times are critical to maintain production schedules. Leading manufacturers have diversified production sites and inventory reserves.

Pricing and Contract Terms

Competitive pricing, flexible payment options, and transparent contractual terms influence procurement strategies.

Traceability and Certification

Suppliers that provide detailed documentation, including batch records and regulatory certificates, aid in compliance and audit readiness.

Key API Suppliers of Amicar (Ethamsylate)

Below are prominent suppliers meeting the above criteria:

Supplier	Region	Certifications	Notes
Hefei Bomei Biotech	China	GMP, ISO	Known for scale and quality
Aurobindo Pharma	India	WHO-GMP, US FDA	Multi-region exporter
Jiangxi Microcore Pharmaceutical	China	GMP	Focused on high-purity APIs
Wockhardt	UK/India	EU-GMP	High-quality standards
BASF SE	Germany	EU-GMP	Specialized APIs

Regulatory Considerations and Quality Control

Sourcing API for Amicar involves navigating complex regulatory landscapes. Manufacturers must ensure compliance with regional and international Good Manufacturing Practices (GMP), adhere to pharmacopeial monographs, and secure necessary documentation for regulatory submissions.

Quality control is non-negotiable, encompassing analytical testing, stability assessments, and validation of manufacturing processes. Importantly, companies should conduct audits and vendor qualification visits to verify compliance and capacity.

Supply Chain and Risk Management

Diversifying API sources mitigates supply disruptions. Establishing multiple qualified suppliers across geographies enhances resilience. Furthermore, maintaining safety stocks and engaging in long-term supply agreements reduces uncertainties, especially during geopolitical or pandemic-related crises.

Emerging Trends in API Sourcing

• Vertical Integration: Some firms increasingly internalize API synthesis to control quality and supply chains.
• Sustainable Manufacturing: Emphasis on green chemistry and eco-friendly processes influences supplier selection.
• Digitalization: Use of blockchain for traceability and real-time tracking enhances supply chain transparency.

Conclusion

The sourcing landscape for Amicar (ethamsylate) API is dominated by key players in China, India, and Europe, each offering diverse options aligned with quality, regulatory compliance, and supply capacity. Pharmaceutical companies must prioritize GMP compliance, robust quality controls, and supply security in their sourcing strategies. Building partnerships with reputable suppliers reduces risks and supports ongoing regulatory and commercial success.

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Key Takeaways

• Diverse Global Supply: Chinese and Indian manufacturers constitute the primary sources of high-quality ethamsylate APIs, supported by European suppliers for high-regulatory markets.
• Regulatory Compliance: Maintaining GMP certification and detailed documentation is essential for API sourcing, especially for regulated markets.
• Quality Assurance: Rigorous testing and quality control protocols are critical to ensure API purity and safety.
• Supply Chain Resilience: Multi-sourcing and long-term agreements reduce risks associated with supply disruptions.
• Emerging Focus Areas: Sustainability, digital traceability, and vertical integration are shaping future API sourcing strategies.

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FAQs

1. What are the main regions producing API for Amicar?
China and India dominate global production, with European and U.S. companies providing specialized, high-standard APIs for regulated markets.

2. How can I verify the quality of an API supplier?
Verify GMP certification, review Certificates of Analysis, conduct on-site audits, and ensure compliance with pharmacopeial standards (USP, EP, JP).

3. What should be considered when negotiating API purchase agreements?
Focus on pricing, lead times, supply capacity, delivery terms, quality specifications, and regulatory documentation.

4. Are biosimilar or generic APIs for Amicar widely available?
Yes, multiple manufacturers produce generic ethamsylate APIs conforming to global standards, but thorough quality verification remains essential.

5. How does regulatory compliance impact API sourcing?
Non-compliance can lead to production halts, regulatory penalties, and compromised drug safety; hence, rigorous adherence to GMP and regional regulations is vital.

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Sources

[1] U.S. Pharmacopeia (USP) Monographs: Specification standards for ethamsylate.
[2] European Pharmacopoeia (EP): Quality standards for hemostatic APIs.
[3] WHO Prequalified APIs: Global recognized standards and approved manufacturers.
[4] Industry Reports: Global API manufacturing capacity and trends.
[5] Regulatory Agencies: Guidance documents from FDA, EMA, and other authorities.