Bulk Pharmaceutical API Sources for AZACTAM IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for AZACTAM IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-886-345
Hangzhou APIChem Technology		AC-4330
Amadis Chemical		A839338
BioChemPartner		BCPP000356
BioChemPartner		BCP9000372
AKos Consulting & Solutions		AKOS015840157
AKos Consulting & Solutions		AKOS015961777

Bulk Active Pharmaceutical Ingredient (API) Sources for AZACTAM in Plastic Container

Last updated: August 6, 2025

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Introduction

Azactam, known generically as aztreonam, is a monobactam antibiotic used extensively for treating serious bacterial infections. Its formulation in plastic containers necessitates careful sourcing of the bulk API to ensure quality, stability, and regulatory compliance. This article provides a comprehensive overview of bulk API sources for aztreonam, focusing on procurement considerations, key suppliers, regional manufacturing landscapes, and implications for pharmaceutical companies.

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Overview of Aztreonam and Its Market Demand

Aztreonam is a narrow-spectrum β-lactam antibiotic targeting Gram-negative bacteria. Its pivotal role in combating resistant bacterial strains amplifies demand, especially in critical care and hospital settings. The global aztreonam market has seen consistent growth, driven by rising bacterial resistance and regulatory approvals [1].

Packaging in plastic containers—typically infusion bags or bottles—demands API suppliers to maintain stringent quality standards, ensuring the final product’s stability and compatibility.

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Criteria for Selecting Aztreonam API Suppliers

Procurement agencies prioritize several factors when sourcing aztreonam API:

• Regulatory Compliance: Suppliers must meet cGMP standards, with approvals from agencies such as the FDA, EMA, or suitable local authorities.
• Quality Certifications: ISO certifications, Batch validation data, and rigorous testing protocols.
• Manufacturing Capacity: Adequate scale to ensure supply consistency and meet global demand.
• Pricing and Lead Times: Competitive costs balanced with reliable delivery.
• Traceability and Documentation: Comprehensive batch records and compliance documentation.

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Key Geographic Regions with API Manufacturers

The primary regions producing aztreonam API include India, China, Europe, and the United States. Each region offers unique advantages:

• India: Known for large-scale API manufacturing with substantial cGMP compliance, cost competitiveness, and flexible production schedules.
• China: Rapidly expanding capacity with technological advancements, though quality assurance requires careful vetting.
• Europe: Focuses on high-quality, regulatory-compliant APIs; often preferred by companies with stringent quality requirements.
• United States: Limited domestic API production for aztreonam; import reliance is common, but local manufacturers support niche demands.

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Leading Suppliers of Aztreonam API

1. Mylan (now part of Viatris)

• Location: India, global manufacturing footprint
• Capabilities: Produces bulk aztreonam API meeting US and European standards.
• Certifications: cGMP, ISO 9001, and specific drug approvals.

2. Dr. Reddy’s Laboratories

• Location: India
• Capabilities: Offers high-quality aztreonam API with robust QC testing.
• Certifications: WHO-GMP, USFDA.

3. Zhejiang Huahai Pharmaceutical

• Location: China
• Capabilities: Has established API manufacturing lines for various β-lactam antibiotics.
• Certifications: Chinese GMP, with ongoing efforts for international regulatory approvals.

4. Fareva

• Location: Europe (France and Germany)
• Capabilities: Focuses on high-value APIs with European regulatory compliance, suitable for premium formulations.

5. Localized Contract API Manufacturers

Regional firms with certified facilities often supply aztreonam, especially for regional markets such as South-East Asia or South America.

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Regulatory and Quality Considerations

Manufacturers seeking to supply aztreonam in plastic containers must ensure their APIs comply with current Good Manufacturing Practices (cGMP). Regulatory agencies' inspections and certifications—like FDA inspections or EMA certification—are critical to establishing credibility. Additionally, quality attributes such as purity (>99%), endotoxin levels, and residual solvents influence the API’s suitability for infusion formulations.

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Supply Chain and Procurement Strategies

Organizations should develop robust supplier vetting processes, including quality audits, review of batch documentation, and validation of stability testing data. Establishing a diversified supplier base mitigates risks associated with regional disruptions, natural disasters, or geopolitical instability.

Considering long-term agreements with API manufacturers offers advantages in price stability and priority supply. Suppliers with existing track records of consistent quality and timely delivery are preferred for critical medications like aztreonam.

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Implications of API Source on Formulation in Plastic Containers

The choice of API supplier influences product stability, compatibility, and shelf-life when formulated in plastic containers. Suppliers who provide APIs with established stability profiles enable easier formulation development and predictable performance. Moreover, API traceability helps prevent contamination or incompatibility issues with plastic materials, such as PVC or polypropylene used in infusion bags and bottles.

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Future Trends and Market Dynamics

• Regulatory Tightening: Increasing scrutiny on API quality standards prompts suppliers to upgrade manufacturing processes.
• Sustainability Initiatives: API manufacturers are adopting greener manufacturing practices, aligning with global environmental standards.
• Supply Chain Digitization: Enhancements in traceability systems facilitate real-time monitoring and reduce counterfeiting risks.

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Key Considerations for Buyers

• Verify Supplier Certifications: Confirm cGMP, ISO, and drug-specific approvals.
• Assess API Purity and Quality Data: Request batch analysis reports, stability data, and endotoxin levels.
• Evaluate Supply Reliability: Consider supplier capacity, lead times, and financial stability.
• Ensure Compatibility: Confirm API specifications align with formulation requirements, especially for infusion in plastic containers.

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Key Takeaways

• The global market for bulk aztreonam API is primarily dominated by Indian and Chinese manufacturers, with European and US suppliers providing high-quality options.
• Procurement decisions should emphasize quality compliance, regulatory approvals, and supply chain reliability.
• Suppliers offering APIs validated for stability in plastic containers streamline formulation development.
• Ongoing regulatory scrutiny and technological advancements continually shape API manufacturing standards.
• Diversifying suppliers enhances supply chain resilience for critical antibiotics like aztreonam.

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FAQs

1. Are there specific regulatory certifications required for aztreonam API suppliers?
Yes, suppliers should hold cGMP compliance certifications from relevant authorities (FDA, EMA, or equivalent). Additional certifications like ISO 9001 are also important for quality management.

2. Can I source aztreonam API from local manufacturers in my country?
Availability depends on regional manufacturing capacity and regulatory approval. Some countries have local producers providing APIs for domestic use, but global companies often prefer established international suppliers for consistency.

3. What quality attributes are critical for aztreonam API in infusion formulations?
High purity (>99%), low endotoxin levels, minimal residual solvents, and verified stability in aqueous, plastic container compatibility are essential.

4. How do suppliers ensure the API’s stability in plastic containers?
Suppliers provide comprehensive stability data, and formulation scientists adapt processes to mitigate potential interactions between API and plastic materials, ensuring product integrity throughout shelf life.

5. What are the risks associated with sourcing aztreonam API from Chinese manufacturers?
Risks include variability in quality, regulatory recognition, and potential delays. Due diligence, including audits and certification verification, mitigates these risks.

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References

[1] MarketsandMarkets. “Antibiotics Market by Type, Application, and Region – Global Forecast to 2030.” (2022).