Bulk Pharmaceutical API Sources for AMINOCAPROIC ACID IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for AMINOCAPROIC ACID IN PLASTIC CONTAINER

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 Aminocaproic Acid in Plastic Containers

Last updated: July 30, 2025

Introduction

Aminocaproic acid, also known as epsilon-aminocaproic acid, is a potent antifibrinolytic agent used extensively to treat bleeding episodes related to surgical procedures, trauma, or bleeding disorders such as hemophilia. As a critical pharmaceutical ingredient, the sourcing of bulk APIs, particularly in formulations stored in plastic containers, requires meticulous validation to ensure stability, purity, and regulatory compliance. This comprehensive analysis explores the global sourcing landscape of aminocaproic acid APIs, focusing on suppliers capable of delivering high-quality products suitable for plastic container storage.

Global API Manufacturing Landscape for Aminocaproic Acid

The demand for aminocaproic acid has expanded globally, driven by the increasing prevalence of bleeding disorders and demand within the surgical and critical care sectors. Major API manufacturers primarily operate within regions with robust pharmaceutical manufacturing infrastructure, including China, India, Europe, and North America.

Leading API Producers

• Chinese Manufacturers: China remains a dominant supplier of aminocaproic acid due to established chemical manufacturing capabilities, cost competitiveness, and regulatory compliance within domestic and export markets. Companies such as Qilu Pharmaceutical and Wuxi AppTec produce aminocaproic acid adhering to GMP standards, with export licenses issued by CNCA (Certification and Accreditation Administration of China). Their capabilities support large-scale bulk production in bulk drums or bulk containers, suitable for transfer into primary packaging like plastic bottles.

• Indian Manufacturers: India’s pharmaceutical sector, with firms like Hikal Ltd. and Spice Fine Chemicals, produces high-grade aminocaproic acid APIs. Indian suppliers are EDQM (European Directorate for the Quality of Medicines & HealthCare) certified and compliant with US FDA standards, offering pharmaceutical-grade APIs with robust stability profiles for storage in plastic containers.

• European and North American Sources: While fewer, certain European and US-based contract manufacturing organizations (CMOs) supply aminocaproic acid APIs adhering to stringent regulatory standards (e.g., FDA, EMA). These suppliers often emphasize high purity, consistent supply, and detailed stability data suitable for sensitive storage in plastic containers.

Key Considerations in Sourcing Aminocaproic Acid APIs

Quality and Regulatory Compliance

• Suppliers must provide Certificates of Analysis (CoA), demonstrating compliance with pharmacopeial standards such as USP, EP, or JP.
• Certificates should include specifications for purity (>99%), residual solvents, heavy metals, and microbial contamination.
• Regulatory approvals or certifications (FDA, EMA, DMF, CEP) contribute to supplier credibility and product acceptance in global markets.

Stability in Plastic Containers

Aminocaproic acid is generally stable; however, the container material and storage conditions significantly influence API integrity. Plastic containers—typically high-density polyethylene (HDPE) or polypropylene—are common in pharmaceutical storage but must be compatible with aminocaproic acid to prevent leaching, adsorption, or degradation.

• Container Compatibility: The chosen plastics should be inert, with prior validation demonstrating no interaction that could compromise API quality.
• Stability Data: Suppliers should provide stability profiles under various storage conditions (e.g., 25°C/60% RH, 40°C/75% RH) to confirm API integrity in plastic containers over the intended shelf life.

Supply Chain Reliability

Ensuring a consistent supply chain involves evaluating the supplier’s manufacturing capacity, lead times, and logistical capabilities. Global disruptions, such as those experienced during the COVID-19 pandemic, underscore the importance of diversified sourcing and inventory management strategies.

Major Suppliers of Aminocaproic Acid in Plastic Containers

Supplier	Region	Certifications	Regulatory Status	Packaging Capabilities	Notes
Qilu Pharmaceutical	China	GMP, ISO	Export licenses, CE, WHO-GMP	Bulk drums, transfer to plastic containers	Large-scale capacity, proven stability data
Hikal Ltd.	India	GMP, ISO	FDA DMF, CEP	Bulk packages suitable for transfer	Emphasis on supply reliability and quality
Wuxi AppTec	China	GMP, ISO	Various international approvals	Custom packaging options	R&D to scale manufacturing capabilities
ČEZ, Ltd.	Europe	GMP	EMA-approved	Pre-packaged APIs, bulk containers	Focus on European market compliance
Sabin Pharma	India	GMP	FDA & CE certifications	Bulk API supplies	Short lead times and competitive pricing

Procurement Strategies for APIs in Plastic Containers

• Validation of Container Compatibility: Pre-approval of plastic containers through compatibility testing ensures product stability.
• Batch Certification and Stability Data: Verify each batch’s stability profile, including any recommendations for Q.S. (quantity sufficient) adjustments or additives to prolong shelf life in plastic packaging.
• Supply Chain Audits: Conduct audits or site visits where feasible to confirm manufacturing practices and quality control measures.

Regulatory and Logistical Challenges

• Storage Conditions: APIs stored in plastic containers should be maintained under manufacturer-recommended conditions to prevent moisture ingress, leaching, or temperature-induced degradation.
• Labeling and Traceability: Proper labeling and documentation ensure compliance with Good Distribution Practices (GDP).
• Global Trade Considerations: Import/export restrictions, tariffs, and customs procedures affect API procurement, especially from regionally concentrated suppliers.

Emerging Trends and Future Outlook

The sourcing landscape is increasingly influenced by:

• Quality Assurance Enhancements: Suppliers adopting advanced analytical methods for in-process and finished product testing.
• Sustainable Packaging: Shift toward environmentally friendly containers with validated inert properties.
• Regional Supply Chain Diversification: To mitigate geopolitical risks, manufacturers and pharma companies are expanding sourcing options across multiple regions.

Conclusion

The procurement of high-quality aminocaproic acid APIs suitable for storage in plastic containers hinges on selecting reliable suppliers with proven GMP compliance, stable supply chains, and comprehensive stability data. Chinese, Indian, and European manufacturers dominate the landscape, offering scalable production and regulatory endorsements. Ensuring container compatibility and implementing rigorous validation procedures are essential to maintain API integrity, safeguarding pharmaceutical quality and efficacy.

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Key Takeaways

• Identify reputable suppliers with GMP certification, regulatory approvals, and established export capabilities, particularly in China, India, and Europe.
• Prioritize stability data demonstrating aminocaproic acid's compatibility and robustness within plastic containers over the product’s shelf life.
• Validate container materials and storage conditions to prevent leaching, adsorption, or degradation, ensuring API quality.
• Diversify supply sources to mitigate supply chain disruptions and enhance procurement security.
• Maintain strict documentation and quality assurance measures throughout procurement, transfer, and storage processes.

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FAQs

1. What are the primary factors influencing the choice of supplier for aminocaproic acid APIs?
Quality certifications (GMP compliance, regulatory approvals), manufacturing capacity, stability data in plastic containers, supply chain robustness, and price competitiveness are critical.

2. Are aminocaproic acid APIs stored safely in all plastic containers?
While generally stable, the API’s compatibility with specific plastic materials must be validated. High-density polyethylene (HDPE) and polypropylene (PP) are commonly used due to their inert properties, but validation remains essential.

3. How can I verify the stability of aminocaproic acid in plastic containers?
Request comprehensive stability data from suppliers, including accelerated and long-term studies under relevant storage conditions, to ensure sustained API integrity in plastic packaging.

4. Which regulatory standards should suppliers meet for aminocaproic acid APIs?
Standards include USP, EP, JP, or Ph. Eur., complemented by certifications such as FDA, EMA, or WHO-GMP depending on the target market.

5. What logistical challenges are associated with sourcing aminocaproic acid APIs globally?
Potential challenges include customs restrictions, tariffs, transportation delays, varying quality standards, and fluctuating supply chain capacities, especially amid global disruptions.

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Sources:

[1] USP Monograph on Aminocaproic Acid. United States Pharmacopeia.
[2] European Pharmacopoeia (EP).
[3] Chinese pharmaceutical industry reports. CNCA certifications and export licenses.
[4] Indian pharmaceutical industry data. ICD and regulatory resources.
[5] Regulatory guidelines from FDA, EMA, and WHO concerning pharmaceutical APIs.