Bulk Pharmaceutical API Sources for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001246654
NovoSeek		101526
Ambinter		KS-1181
Hangzhou APIChem Technology		AC-1275
MolPort		MolPort-005-934-227
ABI Chem		AC1L2R0P
Finetech Industry Limited		FT-0080006

Bulk Active Pharmaceutical Ingredient (API) Sources for Avelox in Sodium Chloride 0.8% in Plastic Container

Last updated: July 29, 2025

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Introduction

Avelox (generic name: moxifloxacin hydrochloride) is a broad-spectrum fluoroquinolone antibiotic, widely used for treating bacterial infections. When formulated as a solution in Sodium Chloride 0.8% for infusion, the API—moxifloxacin hydrochloride—is mixed with a saline solution for intravenous administration. Sourcing high-quality bulk API is essential for pharmaceutical manufacturers to ensure product safety, efficacy, and regulatory compliance. This article examines the primary sources of moxifloxacin hydrochloride API suitable for manufacturing Avelox in Sodium Chloride 0.8% in plastic containers.

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Global API Manufacturing Landscape

The API manufacturing sector for antibiotics like moxifloxacin is concentrated among a few prominent players with robust development, regulatory approvals, and export capabilities. These companies offer pharmaceutical-grade APIs compliant with international standards such as USP, EP, and JP, which are critical for injectable formulations.

Key regions include China, India, and Europe, with China and India dominating the bulk API supply market due to cost advantages and a large manufacturing infrastructure. European companies tend to focus on higher purity APIs aligned with stringent regulatory demands.

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Notable API Suppliers for Moxifloxacin Hydrochloride

1. Chinese API Manufacturers

a. Zhejiang Yongtai Pharmaceutical Co., Ltd.

• Overview: A leading Chinese API producer specializing in fluoroquinolones, including moxifloxacin hydrochloride.
• Capabilities: Facilities compliant with GMP, with extensive experience in injectable APIs.
• Regulatory Standing: Approved by CFDA; capable of supplying API internationally, subject to registration and quality audits.
• Certifications: GMP, ISO 9001, and other quality standards.

b. Shanghai Inno Pharmaceuticals Co., Ltd.

• Overview: Focuses on antibiotic APIs with a diversified portfolio.
• Capabilities: Offers moxifloxacin hydrochloride API that meets pharmaceutical grade standards.
• Supply Focus: Mainly for the Asian and emerging markets; some capability for export to North America and Europe.

c. North China Pharmaceutical Group Corporation (NCPC)

• Overview: One of China's largest API producers with extensive experience manufacturing fluoroquinolones.
• API Product: Moxifloxacin hydrochloride API meeting high purity standards.

2. Indian API Manufacturers

a. Aurobindo Pharma Ltd.

• Overview: Major global API supplier with a comprehensive portfolio including fluoroquinolones.
• API Quality: Meets international standards (USP, EP).
• Market Reputation: Recognized for consistent quality and regulatory compliance.

b. Dishman Pharmaceuticals & Chemicals Ltd.

• Overview: Experienced in API manufacturing, including high-value antibiotics.
• Certifications: GMP, ISO, and other quality certifications.
• Delivery: Capable of large-scale bulk supply.

c. Micro Labs Ltd.

• Overview: Ranks among top Indian API producers, with offerings in fluoroquinolones.
• Quality Assurance: Meets major quality frameworks suitable for injectable APIs.

3. European API Suppliers

a. Teva Pharmaceutical Industries Ltd.

• Overview: Global leader in generic APIs, with a focus on quality and regulatory compliance.
• API Offering: Moxifloxacin hydrochloride API meeting stringent European specifications.
• Regulatory Portfolio: Extensive approvals for APIs used in injectable formulations.

b. Sandoz (Novartis)

• Overview: Supplies high-purity APIs with validated manufacturing processes.
• Certifications: GMP-compliant facilities, with extensive regulatory approvals.

4. Contract Manufacturing and Custom API Suppliers

Companies like BASF, Lonza, and Hetero Labs sometimes offer custom synthesis or contract manufacturing for APIs, including fluoroquinolones. These sources are suitable when the manufacturer requires tailored synthesis routes, specific purity levels, or regulatory support.

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Regulatory and Quality Considerations

Selecting a reliable API source for Avelox in Sodium Chloride 0.8% requires rigorous evaluation of:

• GMP Compliance: Critical for injectable antibiotics; ensures manufacturing standards meet regulatory requirements.
• Certification & Documentation: Certificates of Analysis (CoA), Good Manufacturing Practice (GMP), stability data, and regulatory approval status.
• Purity and Impurity Profiling: The API must meet specified limits for heavy metals, residual solvents, and other impurities to ensure safety.
• Supply Chain Reliability: Consistent supply capacity and lead times are essential for pharmaceutical production schedules.
• Regulatory Approvals: Ensuring the API supplier's product is registered or accepted in target markets (e.g., FDA, EMA, PMDA).

Supply Chain Challenges

The sourcing of API for intravenous formulations like Avelox in saline solutions involves managing risks related to geopolitical issues, regulatory changes, and supply chain disruptions. Import restrictions, quality bottlenecks, and manufacturing delays must be proactively managed through qualification audits and strategic inventory management.

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Conclusion

Manufacturing Avelox in Sodium Chloride 0.8% in plastic containers necessitates sourcing high-grade moxifloxacin hydrochloride API from qualified suppliers with proven regulatory compliance and reliable supply chains. Chinese and Indian manufacturers dominate the bulk API market, offering cost-effective options with GMP compliance suitable for export and domestic use. European API producers, although often more expensive, provide APIs meeting the strictest quality standards, potentially advantageous for markets with heightened regulatory scrutiny.

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Key Takeaways

• The primary sources for moxifloxacin hydrochloride API include leading Chinese, Indian, and European manufacturers.
• Due diligence in evaluating GMP compliance, regulatory approvals, and impurity profiles is critical when selecting an API supplier.
• Geographic diversification can mitigate supply chain risks but may require managing different regulatory frameworks.
• Contract manufacturing organizations (CMOs) can provide customized APIs tailored to formulation-specific needs.
• Establishing long-term supplier relationships enhances stability and quality assurance for intravenous antibiotic products.

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FAQs

1. What are the main factors to consider when sourcing API for injectable antibiotics?
Regulatory compliance (GMP certification), API purity and impurity profile, supply chain reliability, and documented regulatory approvals are essential factors.

2. Are Chinese API suppliers suitable for pharmaceutical-grade moxifloxacin hydrochloride?
Yes, several Chinese manufacturers comply with international GMP standards and can supply pharmaceutical-grade APIs, provided thorough qualification processes are followed.

3. How does the choice of API source impact regulatory approval for Avelox?
Using APIs from approved, certified suppliers simplifies registration processes, reduces regulatory hurdles, and ensures consistent product quality.

4. Can APIs from India meet stringent European or US standards?
Indian API manufacturers such as Aurobindo and Hetero Labs produce APIs that meet USP, EP, and other international standards suitable for injectable formulations.

5. What supply chain risks are associated with bulk API sourcing?
Risks include geopolitical disruptions, quality compliance issues, manufacturing delays, and logistical challenges, which can impact timely production.

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References

1. [1] World Health Organization. Pharmaceutical Quality Assurance Guidelines.
2. [2] U.S. Pharmacopeia. Monograph for Moxifloxacin Hydrochloride.
3. [3] European Medicines Agency. Guidelines on Good Manufacturing Practice.
4. [4] Industry Reports on API Manufacturing and Supply Chains.