Bulk Pharmaceutical API Sources for LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001246758
NovoSeek		149096
Sigma-Aldrich		28266_SIGMA
TCI (Tokyo Chemical Industry)		L0193
MolPort		MolPort-002-885-835
Hangzhou APIChem Technology		AC-7593

Bulk Active Pharmaceutical Ingredient (API) Sources for Levaquin in Dextrose 5% in Plastic Container

Last updated: July 29, 2025

Introduction

Levaquin (levofloxacin) is a broad-spectrum fluoroquinolone antibiotic widely used in hospital and outpatient settings for treating a spectrum of bacterial infections. As a critical pharmaceutical component, the sourcing of levofloxacin API, particularly for formulations such as Levaquin in dextrose 5% in plastic containers, requires rigorous validation to ensure quality, efficacy, and regulatory compliance. This article explores the global API suppliers specializing in levofloxacin, their manufacturing capabilities, and considerations critical to sourcing high-quality bulk APIs for intravenous (IV) formulations.

Overview of Levofloxacin API Market

Levofloxacin, a stereoisomer of ofloxacin, enjoys high demand due to its efficacy against respiratory, urinary, skin, and soft tissue infections. The pharmaceutical industries primarily source the API from manufacturers with advanced synthesis capabilities, strict Good Manufacturing Practices (GMP), and robust quality assurance systems. The API's sourcing involves assessing regulatory approvals, purity standards, batch consistency, and supply chain robustness.

Key Global API Suppliers for Levofloxacin

1. Synthesis and Manufacturing Capabilities

Leading suppliers offer levofloxacin API with compliance to international standards such as USP, EP, and JP. Manufacturers with extensive R&D infrastructure and GMP-certified facilities ensure batch-to-batch consistency, critical for sterile IV formulations like Levaquin in dextrose 5%.

2. Major Suppliers and Regions

a. China

China’s pharmaceutical industry dominates API manufacturing, offering competitive pricing and large-scale production. Major Chinese API manufacturers with GMP certification and active export records include:

• Hinan Pharmaceutical Co., Ltd. — offers levofloxacin API with USP certifications, extensive export licensing, and validated manufacturing processes.
• Shandong Luyang Pharmaceutical Co., Ltd. — experienced in producing high-purity fluoroquinolone APIs meeting international standards.
• North China Pharmaceutical Group Corporation (NCPC) — provides APIs with comprehensive quality documentation and regulatory support.

b. India

India remains a significant API producer, with firms adhering to strict quality and regulatory standards:

• Aurobindo Pharma Ltd. — advanced synthesis capabilities for levofloxacin API, compliant with regulatory agencies.
• Mitra Pharma — offers high-purity APIs, with certifications aligning with global standards.
• Bharat Serums & Vaccines Ltd. — known for stringent quality control and reliable supply chain management.

c. Europe and North America

While less dominant in API bulk manufacturing compared to China and India, select European and North American producers specializing in sterile injectable APIs include:

• Bachem AG (Switzerland) — produces high-quality APIs with a focus on injectable-grade products, with a strong reputation for purity and consistency.
• Almac Group (UK) — provides custom synthesis services, including APIs for sterile formulations.

3. Regulatory Landscape and Quality Assurance

API manufacturers serving the IV pharmaceutical market must meet rigorous standards:

• GMP Certification: Essential to ensure manufacturing complies with regulatory authorities such as the FDA, EMA, and PMDA.
• USP/EP/JPE Certifications: Certifications indicating adherence to pharmacopoeial standards.
• DMF (Drug Master File): Availability of DMF submissions facilitates acceptance of APIs by regulators and formulators.

Manufacturers compliant with these standards attract partnerships from pharmaceutical companies seeking reliable sources for sterile API supplies.

4. Supply Chain Considerations

Reliability in supply, documentation transparency, and ability to scale production are vital. Suppliers offering flexible batch sizes, robust logistics, and contingency plans mitigate risks associated with shortages or quality issues.

5. Emerging Trends in API Sourcing

• Vertical Integration: Larger firms increasing in-house synthesis capabilities to control quality.
• Active Engagement with Regulators: Ensures seamless approval processes for sterile formulations.
• Sustainable Manufacturing: Environmental compliance and sustainable practices are gaining importance among major suppliers.

Challenges in Sourcing Levofloxacin API

• Regulatory Hurdles: Variability across regions necessitates due diligence.
• Quality Concerns: Ensuring purity (>99%) and absence of residual solvents or impurities.
• Price Sensitivity: Balancing cost with quality remains a persistent challenge, especially for sterile injectable APIs.
• Supply Chain Disruptions: Geopolitical issues, logistics, and pandemics may impact supply continuity.

Quality Considerations for API in Sterile Formulations

When sourcing levofloxacin API for IV use, especially in dextrose 5% solution, manufacturers must prioritize:

• Pharmacopoeial Compliance: Ensuring the API meets USP, EP, or JP monographs.
• High Purity and Low Impurities: To prevent adverse reactions and ensure patient safety.
• Particle Size and Solubility: Compatibility for IV formulation, requiring APIs to have specific physical properties.
• Stability Data: Demonstrating chemical and microbiological stability in solution.

Conclusion

Reliable sourcing of levofloxacin API for injectable formulations like Levaquin in dextrose 5% is pivotal to maintaining product quality and supply continuity. Chinese and Indian API manufacturers dominate global supply chains, offering high-quality products aligned with international standards. Engaging with suppliers possessing rigorous GMP certification, comprehensive documentation, and proven regulatory acceptance is vital. As the demand for sterile APIs increases, so does the importance of sourcing from suppliers committed to quality, sustainability, and supply chain resilience.

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Key Takeaways

• The primary sources for bulk levofloxacin API are manufacturers in China and India, with select European and North American companies catering to specialized or high-quality demands.
• Regulatory compliance, GMP certification, and adherence to pharmacopeial standards are non-negotiable factors in sourcing sterile APIs for IV use.
• Supply chain stability, consistent quality, and scalability are critical considerations, especially amid global disruptions.
• Manufacturers with advanced synthesis, quality assurance systems, and regulatory documentation facilitate smoother approval and supply processes.
• Close alignment with regulatory authorities and continuous quality monitoring are essential to meet stringent safety requirements for injectable APIs.

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FAQs

1. What are the leading regions for sourcing bulk levofloxacin API?
China and India are the primary regions, offering large-scale, cost-effective manufacturing. Europe and North America supply high-purity, specialized APIs for regulatory markets requiring stringent quality standards.

2. How can buyers assess the quality of levofloxacin API suppliers?
Review GMP certifications, pharmacopeial compliance, DMF filings, quality control records, and previous validation data. Audit manufacturing facilities when possible and verify batch consistency.

3. What are the essential quality specifications for API in IV formulations?
Purity (>99%), low residual solvent levels, absence of endotoxins, appropriate particle size distribution, chemical stability, and compliance with pharmacopoeia standards.

4. How do regulatory agencies influence API sourcing decisions?
Regulatory approvals and acceptance of APIs depend on supplier certifications, documentation, and compliance with regional standards, impacting the ability to register finished products internationally.

5. What are the risks of sourcing levofloxacin API from emerging suppliers?
Risks include inconsistent quality, regulatory non-compliance, supply chain instability, and lack of comprehensive documentation, which could delay approvals or impact product safety.

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Sources
[1] U.S. Pharmacopeia, USP Monograph for Levofloxacin.
[2] European Pharmacopoeia, Monograph on Levofloxacin.
[3] Chinese Pharmacopoeia, Standards for Levofloxacin.
[4] Regulatory filings and product dossiers from leading Chinese and Indian API manufacturers.
[5] Industry reports on pharmaceutical API manufacturing and supply chain trends.