AVIBACTAM SODIUM; AZTREONAM: Pharmaceutical manufacturers, suppliers, and wholesalers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	EMBLAVEO	avibactam sodium; aztreonam	POWDER;INTRAVENOUS	217906	NDA	AbbVie Inc.	0074-3878-10	10 VIAL, SINGLE-DOSE in 1 CARTON (0074-3878-10) / 12 mL in 1 VIAL, SINGLE-DOSE (0074-3878-01)	2025-02-07
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

In the competitive landscape of pharmaceuticals, sourcing high-quality active pharmaceutical ingredients (APIs) is paramount to ensure drug efficacy, safety, and regulatory compliance. This report focuses on two critical antibiotics: Avibactam Sodium and Aztreonam, delineating key suppliers, market dynamics, and strategic considerations for stakeholders seeking reliable sources.

Overview of Avibactam Sodium and Aztreonam

Avibactam Sodium is a novel β-lactamase inhibitor often combined with ceftazidime to combat multidrug-resistant bacterial infections. Its commercial success hinges on the availability of high-purity APIs supplied by trusted manufacturers capable of meeting stringent quality standards.

Aztreonam is a monobactam antibiotic effective against Gram-negative bacteria, notably in hospital settings for severe infections. Given its widespread clinical use, the global supply chain for aztreonam API is robust but highly regulated.

Leading Suppliers for Avibactam Sodium

1. Shenzhen Yitoa Pharmaceutical Co., Ltd.

Overview: A prominent Chinese API manufacturer specializing in β-lactamase inhibitors and other complex APIs.
Capabilities: Yitoa supplies Avibactam Sodium with verified GMP compliance, offering customization per client needs.
Certifications: GMP certification from Chinese authorities; current efforts towards EU-GMP and FDA approvals bolster credibility.
Market Position: Known for cost competitiveness and high-volume production, Yitoa serves global markets, including North America, Europe, and Asia.

2. WuXi AppTec

Overview: A leading global contract development and manufacturing organization (CDMO) with extensive API production capabilities.
Capabilities: WuXi offers high-quality Avibactam Sodium, leveraging advanced manufacturing processes and stringent quality assurance.
Certifications: Multiple certifications including ISO, GMP, and FDA thresholds, facilitating easier regulatory approval processes.
Market Position: Preferred supplier for multinational pharmaceutical companies seeking reliable, research-stage to commercial-scale production.

3. Sanyo Chemical Industries, Ltd.

Overview: Japanese specialty chemical and pharmaceutical ingredient manufacturer.
Capabilities: Sanyo supplies premium-grade Avibactam Sodium, emphasizing purity and consistency.
Certifications: GMP and ISO certifications, with a focus on regulatory compliance, especially within Asian markets and Europe.
Market Position: Targeted at premium segment clients requiring high-grade APIs.

4. Other Notable Suppliers

Shenzhen Inno Pharmchem Co., Ltd.
Meryer (Shanghai) Chemical Technology Co., Ltd.
Suzhou Ribo Life Science Co., Ltd.

These firms provide varied options depending on regulatory requirements, pricing, and volume needs.

Key Suppliers for Aztreonam

1. GSK (GlaxoSmithKline)

Overview: Historically a major producer of aztreonam API, GSK maintains a leading position due to established manufacturing infrastructure.
Capabilities: Delivers high-purity aztreonam with proven quality and regulatory adherence.
Market Status: GSK’s APIs are often used as benchmarks for quality and purity, although their commercial APIs may be limited or marketed through licensing agreements.

2. ZetaPharm (Zhejiang ZetaPharm Inc.)

Overview: Chinese pharmaceutical manufacturer offering cost-effective aztreonam APIs.
Capabilities: Focuses on high-volume production with adherence to cGMP standards.
Certifications: GMP, ISO, and sometimes USDMF (United States Drug Master File) registration.
Market Presence: A preferred supplier for generic drug manufacturers in Asia and emerging markets.

3. North China Pharmaceutical Group Corporation (NCPC)

Overview: National enterprise based in China with extensive API manufacturing capabilities.
Capabilities: Supplies aztreonam API with consistent quality, targeting both the domestic Chinese market and international export.
Certifications: GMP, ISO, and compliance with several international standards.

4. Other Suppliers

Hubei Tianda Pharmaceutical Co., Ltd.
Shandong Lukang Pharmaceutical Co., Ltd.
Hainan Haipeptide Bio-Pharm Co., Ltd.

These companies offer additional sources for aztreonam, especially for buyers prioritizing cost-effective solutions.

Market Dynamics and Key Considerations

Regulatory Compliance

Sourcing from suppliers with strict regulatory compliance (GMP, FDA, EMA approvals) is critical to facilitate smooth registration and market entry. Notably, WuXi AppTec and GSK possess comprehensive certifications, which ease regulatory hurdles.

Cost and Supply Security

Chinese suppliers like ZetaPharm and Hubei Tianda offer competitive pricing but may face variations in regulatory acceptance depending on the target market. Conversely, suppliers like WuXi and GSK balance quality with higher costs but provide greater assurance of supply continuity.

Manufacturing Capacity and Lead Time

Global demand for these APIs fluctuates, influenced by antibiotic resistance trends and pandemic pressures. Suppliers with scalable manufacturing, such as WuXi and Yitoa, are better positioned to meet urgent or large-volume needs.

Quality Assurance

Verification of purity, batch consistency, and adherence to pharmacopoeial standards (USP, EP, BP) is essential. Notable suppliers routinely publish Certificates of Analysis (CoA) and conduct rigorous purification processes.

Strategic Sourcing Recommendations

Collaborate with suppliers holding international regulatory approvals when expanding into regulated markets.
Conduct Tier 1 audits and quality due diligence before engagement.
Consider geographic diversification to mitigate supply chain disruptions.
Negotiate flexible MOQs aligned with market demand and inventory strategies.

Conclusion

The supply landscape for Avibactam Sodium and Aztreonam APIs is characterized by a mix of established multinational corporations and competitive manufacturers from China and Asia. Companies seeking these APIs must prioritize regulatory compliance, consistent quality, robust supply chains, and cost-effectiveness. Long-term partnerships with suppliers like WuXi AppTec, GSK, or certified Chinese manufacturers can support sustained product availability, regulatory approval, and market expansion.

Key Takeaways

Regulatory compliance is non-negotiable; select suppliers with proven GMP certification and international approvals.
Chinese manufacturers offer competitive pricing and high-volume manufacturing but require thorough quality validation.
Global CDMOs like WuXi AppTec provide scalable manufacturing and regulatory support, advantageous for quality-centric companies.
Diversification of suppliers reduces risk and ensures supply chain resilience amid geopolitical or pandemic-related disruptions.
Due diligence must include verifying certifications, conducting audits, and evaluating past performance to ensure quality standards.

FAQs

Q1. Are Chinese API suppliers compliant with international regulatory standards?
A1. Many Chinese suppliers, such as ZetaPharm and Hubei Tianda, have achieved GMP certification and ISO standards, with some pursuing or maintaining FDA and EMA approvals. However, compliance levels vary; rigorous validation and audits are essential before procurement.

Q2. How does the quality of APIs from Chinese manufacturers compare to Western companies?
A2. Reputable Chinese manufacturers with GMP certification can produce APIs meeting or exceeding international quality standards. Due diligence, including validation reports and Certificates of Analysis, is crucial to verify quality.

Q3. What are the typical lead times for sourcing Avibactam Sodium and Aztreonam APIs?
A3. Lead times depend on supplier capacity and order volume, generally ranging from 8 to 20 weeks. Established suppliers with large-scale capacity tend to offer shorter lead times.

Q4. Can smaller pharmaceutical firms access reliable sources of these APIs?
A4. Yes. Many Chinese and Asian manufacturers cater to smaller batches with flexible MOQs while maintaining quality standards. Engaging with reputable brokers or CMOs can facilitate access.

Q5. What regulatory hurdles exist when importing APIs from China?
A5. Importing APIs into regulated markets requires documentation, certifications, and compliance with local regulatory frameworks like the FDA or EMA. Ensuring supplier certifications and conducting audits mitigates potential hurdles.

References

[1] Market analysis reports and company websites
[2] Pharmaceutical regulatory standards (GMP, FDA, EMA)
[3] Industry publications on API sourcing and quality standards

Suppliers and packagers for generic pharmaceutical drug: AVIBACTAM SODIUM; AZTREONAM