Bulk Pharmaceutical API Sources for amikacin sulfate

Bulk Pharmaceutical API Sources for amikacin sulfate

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		A1774_SIGMA
NovoSeek		38351
ISpharm		I06-1032
MolPort		MolPort-003-925-527
MolPort		MolPort-006-709-404
ABI Chem		AC1L1ZLB
ABI Chem		AC1NWAK0

Bulk Active Pharmaceutical Ingredient (API) Sources for: AMIKACIN SULFATE

Last updated: July 29, 2025

Introduction

Amikacin sulfate is a broad-spectrum aminoglycoside antibiotic primarily employed for serious bacterial infections, such as those caused by Pseudomonas aeruginosa, Klebsiella spp., and Mycobacteria. Given its clinical significance, the procurement of high-quality, reliable bulk active pharmaceutical ingredient (API) supplies is imperative for pharmaceutical manufacturers. This article provides a comprehensive analysis of global API sources for amikacin sulfate, including key manufacturers, geographic distribution, quality standards, and sourcing considerations pertinent to industry stakeholders.

Overview of Amikacin Sulfate API

Amikacin sulfate is synthesized through complex fermentation and chemical processes involving Micromonospora spp. bacteria. The API's production entails stringent quality controls, including purity levels exceeding 98%, residual solvents, and endotoxin limits conforming to pharmacopeial standards (USP, EP, JP).

Market Demand and Trends

The increasing prevalence of resistant bacterial strains has sustained demand for amikacin sulfate, especially in developing regions where antibiotics are vital for public health. The API market's growth correlates with global healthcare infrastructure strengthening, compounded by regulation-driven quality requirements for imported APIs.

Leading API Suppliers for Amikacin Sulfate

1. Indian Manufacturers

a. Sun Pharma

• Sun Pharma is a prominent Indian pharmaceutical company producing amikacin sulfate API, conforming to international standards.
• Certifications: WHO-GMP, USFDA, EUGMP.
• Supply Capacity: Large-scale manufacturing with annual capacities exceeding several tons.
• Quality Standards: Meets USP, EP, and JP monographs.

b. Aurobindo Pharma

• Aurobindo has diversified API production facilities capable of supplying high-quality amikacin sulfate.
• Certifications: USFDA, EMA, MHRA.
• R&D Focus: Process optimization and impurity control.
• Supply Reliability: Established global distribution channels.

c. Cipla

• Cipla’s API division supplies amikacin sulfate suitable for both domestic and export markets.
• Quality Control: Rigorous testing aligned with pharmacopeial standards.
• Strategic Alliances: Agreements with third-party manufacturers for increased capacity.

2. Chinese API Producers

a. North China Pharmaceutical Group Corporation (NCPC)

• One of China’s leading API manufacturers, including amikacin sulfate.
• Market Position: Competitive pricing with adherence to quality standards.
• Certifications: China GMP, some facilities hold USFDA/EU approvals.

b. Zhejiang Yuechi Pharmaceutical Co., Ltd.

• Focuses on aminoglycoside APIs, including amikacin sulfate.
• Regulatory Approvals: CE Mark, Chinese GMP.
• Production Volume: Significant, with export-oriented pipelines.

c. Zhejiang Hisun Pharmaceutical Co., Ltd.

• Established in antibiotic APIs with export experience.
• Quality Assurance: Stringent process controls ensuring API purity.

3. European and US API Manufacturers

While fewer in number, some European and US companies produce and supply amikacin sulfate API, often primarily for regulatory compliance and specialty markets.

a. TEVA Pharmaceuticals

• Offers amikacin sulfate API adhering to strict US and European pharmacopoeial standards.
• Certification: USFDA, EUGMP.

b. Kavetska Pharmaceutical Plant (Ukraine)

• Supplies APIs, including aminoglycosides, adhering to GMP standards.
• Note: API sourcing from Eastern Europe remains viable for bulk procurement.

4. Contract Manufacturing and Custom Synthesis

The complexity of amikacin sulfate production invites engagement with Contract Development and Manufacturing Organizations (CDMOs). Major players include:

• China’s Shanghai ChemPartner
• India’s Laurus Labs

These organizations offer reputation, scalable capacity, and quality assurance aligned with global pharmacopeial standards.

Sourcing Considerations

Quality and Regulatory Compliance

High-purity API with consistent batch-to-batch quality is non-negotiable. Suppliers must demonstrate compliance with Good Manufacturing Practices (GMP), and possess necessary certifications (USFDA, EMA, WHO-GMP). Analytical capabilities, including HPLC purity analyses, residual solvent testing, and endotoxin limits, are essential quality indicators.

Pricing and Capacity

While China and India dominate due to cost competitiveness, premium markets often prefer suppliers with USFDA or EMA approval to mitigate regulatory risks. Capacity constraints may influence procurement timelines; therefore, establishing relationships with multiple manufacturers ensures supply stability.

Logistics and Supply Chain

Global supply chains are sensitive to geopolitical and economic fluctuations. Diversified sourcing reduces the risk of disruptions. Logistics considerations include export documentation, import tariffs, and shipping duration.

Intellectual Property & Licensing

Amikacin sulfate synthesis is well-established; however, licensing agreements may influence supplier selection, especially within regulated markets.

Emerging Developments and Future Outlook

Innovations in fermentation technology and process efficiencies are expected to enhance yields and reduce costs. Additionally, increasing regulatory scrutiny may favor suppliers with proven compliance history. The trend toward API consolidation could reduce the number of pure-play amikacin sulfate providers, emphasizing the importance of thorough due diligence.

Conclusion

The global API landscape for amikacin sulfate encompasses diverse geographical sources, with Indian and Chinese manufacturers leading mass supply, complemented by specialized suppliers in Europe and the US. Procurement strategies should prioritize quality compliance, reliable capacity, and supply chain robustness. Engaging with reputable suppliers possessing requisite certifications and transparent quality systems ensures pharmaceutical companies can meet regulatory requirements and patient safety standards.

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Key Takeaways

• India and China dominate global amikacin sulfate API production, offering cost-effective bulk supplies.
• Suppliers with WHO-GMP, USFDA, or EMA approvals provide greater regulatory assurance.
• Quality parameters such as purity (>98%), residual solvents, and endotoxin limits are critical selection criteria.
• Establishing multi-supplier relationships enhances supply stability amid potential geopolitical or logistical challenges.
• Technological innovations and regulatory trends will influence supply dynamics; continuous due diligence is essential.

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FAQs

1. What are the primary factors influencing the choice of API suppliers for amikacin sulfate?
Quality standards (GMP compliance, purity), regulatory certifications, manufacturing capacity, supply reliability, and cost are the critical factors.

2. Are there any regional restrictions on sourcing amikacin sulfate API?
Regional regulations may restrict imports; for example, certain countries require USFDA or EMA approval. Import restrictions and tariffs should also be considered.

3. How does API quality impact pharmaceutical manufacturing and patient safety?
High-quality APIs ensure product efficacy, stability, and safety, minimizing risks of adverse reactions due to impurities or variability.

4. Can I source amikacin sulfate API directly from Chinese manufacturers for global distribution?
Yes, many Chinese API manufacturers export globally; however, confirmation of certifications, quality systems, and regulatory compliance is essential.

5. What is the current market outlook for amikacin sulfate API?
Growing antibiotic resistance and healthcare needs sustain demand. Focus on regulatory compliance and capacity expansion will influence supply and pricing.

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Sources

[1] U.S. Pharmacopeia. "Amikacin Sulfate Monograph." USP, 2022.
[2] European Pharmacopoeia. "Amikacin Sulfate. Monograph." EP, 2022.
[3] Indian Pharmaceutical Alliance. "Leading API Manufacturers." 2023.
[4] China Pharmacopoeia Committee. "API Manufacturers Directory." 2022.
[5] MarketWatch. "Global Antibiotic API Market Trends," 2023.