Bulk Pharmaceutical API Sources for AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		A1774_SIGMA
NovoSeek		38351
MolPort		MolPort-003-925-527
ABI Chem		AC1L1ZLB
Ambinter		Ambap149022-22-0
Chembase.cn		133774
AstaTech, Inc.		40003

Bulk Active Pharmaceutical Ingredient (API) Sources for Amikin in Sodium Chloride 0.9% in Plastic Container

Last updated: August 7, 2025

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Introduction

Amikin (generic: amikacin) is an aminoglycoside antibiotic predominantly used to treat serious bacterial infections, including pneumonia, septicemia, and urinary tract infections. It’s typically administered via intravenous (IV) infusion, often in a solution containing sodium chloride 0.9%. Ensuring reliable bulk API sourcing is critical for pharmaceutical companies manufacturing Amikin in sodium chloride 0.9% (normal saline) in plastic containers. This article examines key API suppliers, quality considerations, regulatory standards, and the landscape for sourcing Amikacin API.

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API Manufacturing and Global Production Landscape

Amikacin is produced predominantly through fermentation of genetically modified microorganisms, particularly Micromonospora species. As a semi-synthetic antibiotic, its production involves complex biosynthetic and purification processes, making sourcing strategic for pharmaceutical manufacturers.

Major API producers for amikacin are concentrated primarily in India, China, and certain European countries, owing to cost efficiencies and manufacturing capabilities driven by strengthening pharmaceutical export sectors in these regions. Major players often operate under stringent GMP (Good Manufacturing Practice) standards aligned with regulatory authorities like the FDA (United States Food and Drug Administration) and EMA (European Medicines Agency).

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Key Suppliers of Amikacin API

1. Sierra Biotech (India)

Sierra Biotech is a notable Indian API manufacturer with a focus on aminoglycosides, including amikacin. They adhere to WHO-GMP standards and hold certifications from US and European authorities. Their production facilities are ISO 9001, 14001, and 45001 certified, ensuring high-quality API suitable for sterile injectable formulations.

2. Vinh Phuc Special Material JSC (Vietnam)

This Vietnam-based manufacturer specializes in antibiotics, with a track record in producing high-grade amikacin API. They comply with both US and European regulations, with product dossiers supporting regulatory submissions globally.

3. Hubei New Dami Pharmaceutical (China)

Hubei New Dami Pharmaceutical is one of China's leading API producers for aminoglycosides, including amikacin. The company maintains GMP compliance and exports to several regulated markets, emphasizing product quality and supply stability.

4. Aurobindo Pharma (India)

Aurobindo is a major global pharmaceutical player, producing a wide portfolio of APIs, including amikacin. Their facilities operate under strict GMP standards, and the company supplies APIs for sterile injectable formulations worldwide.

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

Hengrui develops and supplies amikacin API, with manufacturing practices aligned with international standards. Their focus on biosynthesis and purification processes ensures high purity levels.

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Quality and Regulatory Standards for API Suppliers

Safety and efficacy in injectable formulations demand APIs that meet rigorous standards, including:

• GMP Compliance: Ensures consistent quality, purity, and strength.
• API Certificates of Analysis (CoA): Must confirm identity, potency, residual solvents, heavy metals, endotoxins, and microbial limits.
• Regulatory Approvals: Suppliers should possess approvals or certifications from key authorities like FDA, EMA, and WHO Prequalification.
• Batch-to-Batch Consistency: Reliable manufacturing processes for consistent API quality over time.

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Sourcing Considerations for Amikacin API

When choosing API suppliers for Amikin in sodium chloride 0.9%, consider:

• Supply Chain Stability: Evaluate supplier capacity, production lead times, and contingency plans.
• Traceability and Documentation: Require comprehensive documentation for regulatory submissions and audits.
• Pricing and Payment Terms: Balance costs against quality standards and supply reliability.
• Localization and Logistics: Consider proximity to manufacturing facilities to reduce transit times and contamination risks.
• Regulatory Track Record: Prefer suppliers with established compliance and inspection history.

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Formulation Compatibility: Amikacin in 0.9% Sodium Chloride in Plastic Containers

Amikacin API is compatible with sodium chloride 0.9%, forming an isotonic infusion suitable for intravenous administration. Manufacturing involves dissolving high-purity API into sterile sodium chloride solution under aseptic conditions. The API’s purity and endotoxin levels directly influence product safety and shelf life.

Plastic container suitability depends on API stability and interaction. Polypropylene and polyethylene containers are standard, as they exhibit minimal leaching and are compatible with sterile solutions like amikacin in sodium chloride 0.9%. Suppliers must provide stability data supporting container compatibility.

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Market Trends and Future Outlook

The demand for broad-spectrum antibiotics like amikacin remains steady, intensified by rising antimicrobial resistance (AMR). The COVID-19 pandemic underscored supply chain vulnerabilities, prompting manufacturers to diversify sources and invest in upstream API production capacity.

Regulatory agencies are increasingly emphasizing API quality, pushing manufacturers toward higher standards, such as ICH Q7 for Active Pharmaceutical Ingredients. Suppliers with robust GMP systems and proven compliance will be preferable, with continued growth expected in Indian and Chinese API manufacturing sectors.

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Conclusion

Securing high-quality, reliable API sources for amikacin in saline infusion is crucial for pharmaceutical manufacturers aiming to produce Amikin in sodium chloride 0.9% in plastic containers. Leading producers in India, China, and Vietnam—such as Sierra Biotech, Hubei New Dami, and Aurobindo—offer compliant, high-quality APIs aligned with international standards. Due diligence in supplier qualification, adherence to quality protocols, and supply chain resilience will underpin successful manufacturing and regulatory approval.

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Key Takeaways

• India and China dominate API production for amikacin, with Vietnam emerging as a significant alternative supplier.
• Regulatory compliance and GMP certification are non-negotiable for API sourcing to ensure safety and efficacy.
• Compatibility with plastic containers depends on API purity and stability data, emphasizing the importance of supplier documentation.
• Diversifying API sources mitigates supply chain risks amid growing global demand and antimicrobial resistance challenges.
• Continuous quality audits and comprehensive due diligence are critical for maintaining supply integrity.

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FAQs

1. What are the primary factors influencing the choice of API suppliers for amikacin?
Factors include GMP compliance, regulatory certifications, consistency in batch quality, supply chain reliability, and cost.

2. How does API purity influence the safety of Amikin in sodium chloride infusion?
High purity reduces risks of endotoxins, residual solvents, and contaminants, ensuring patient safety and regulatory compliance.

3. Are regional regulations a concern when sourcing amikacin API from different countries?
Yes. Suppliers must meet the regulatory standards of the target markets (e.g., FDA, EMA). Verification of certifications and audit readiness is essential.

4. What are the key documentation requirements from API suppliers?
Certificates of Analysis, stability data, manufacturing licenses, GMP certificates, and process validation reports are essential.

5. How has the COVID-19 pandemic affected the API supply chain for antibiotics like amikacin?
Disruptions led to increased emphasis on diversification, stockpiling, and investment in local API manufacturing to ensure uninterrupted supply.

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References
[1] WHO Good Manufacturing Practices (GMP) Guidelines for Active Pharmaceutical Ingredients.
[2] FDA and EMA Regulatory Guidelines for API Quality Standards.
[3] Industry Reports on Global API Manufacturing and Supply Chain Dynamics.
[4] Company Websites and Certifications of Sierra Biotech, Hubei New Dami, and Aurobindo Pharma.