AZACTAM: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bristol Myers Squibb	AZACTAM	aztreonam	INJECTABLE;INJECTION	050580	NDA	E.R. Squibb & Sons, L.L.C.	0003-2560-16	10 VIAL, SINGLE-DOSE in 1 CARTON (0003-2560-16) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2010-04-01
Bristol Myers Squibb	AZACTAM	aztreonam	INJECTABLE;INJECTION	050580	NDA	E.R. Squibb & Sons, L.L.C.	0003-2570-16	10 VIAL, SINGLE-DOSE in 1 CARTON (0003-2570-16) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2010-04-01
Bristol Myers Squibb	AZACTAM	aztreonam	INJECTABLE;INJECTION	050580	NDA	A-S Medication Solutions	50090-7494-0	10 VIAL, SINGLE-DOSE in 1 CARTON (50090-7494-0) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2010-04-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 6, 2025

Introduction

AZACTAM, known generically as aztreonam, is a monobactam antibiotic primarily used in the treatment of various bacterial infections, including respiratory, urinary tract, skin, and gynecological infections. Approved by regulatory authorities such as the FDA, AZACTAM is a critical component in combating resistant bacterial strains. Its demand spans global markets, and its supply chain involves a spectrum of manufacturers, biosynthesis sources, and distribution channels. Understanding the key suppliers involved in producing AZACTAM provides insight into market dynamics, supply security, and potential patent or licensing considerations.

Manufacturers of AZACTAM

1. Hospitals and Contract Manufacturing Organizations (CMOs)

Several pharmaceutical companies serve as primary producers or outsource manufacturing through CMOs. Historically, markets such as the United States, Europe, and emerging regions rely on established pharmaceutical manufacturers for consistent supply.

BarraCell Pharmaceuticals: As a prominent biosimilars and generics manufacturer, BarraCell has expanded into producing aztreonam, capitalizing on market demand driven by antibiotic resistance concerns.
Sandoz International GmbH: A division of Novartis, Sandoz manufactures a broad portfolio of generic injectables, including aztreonam, ensuring high-quality production aligned with international standards.
Teva Pharmaceutical Industries: Known for its extensive generic portfolio, Teva manufactures sterile injectable antibiotics, including AZACTAM, catering mainly to North American and European markets.
Mylan (now part of Viatris): With a global footprint, Mylan has historically produced aztreonam as part of its extensive antibiotic line, supplying markets across Asia and Africa.

2. Patent and Original Innovator Companies

Prior to generic entry, the original patent holder of AZACTAM was:

GlaxoSmithKline (GSK): Initially developed and marketed aztreonam. Since patent expiry, GSK's involvement has shifted towards licensing and patent management.
Abbott Laboratories (now AbbVie): Historically involved in manufacturing or licensing the drug in specific territories, although market presence has diminished post-genericization.

Key Suppliers and Market Players

A. Global Generics Manufacturers

The flagship in the global AZACTAM supply chain stems from a host of generic manufacturers, which include:

Mundipharma: Supplies aztreonam in various formulations across Europe and Asia, focusing on hospital injectables.
Cipla Ltd.: An Indian pharmaceutical giant producing affordable versions of aztreonam mainly for domestic markets and exports.
Zydus Cadila: An Indian firm manufacturing aztreonam injections, expanding access in low- and middle-income countries (LMICs).
Hikma Pharmaceuticals: A key supplier to the Middle East and North Africa (MENA) regions, Hikma's manufacturing complies with rigorous international standards.

B. Regional and Specialty Suppliers

Some regional players focus on specific markets with tailored formulations:

Aurobindo Pharma: Supplies aztreonam in India and through export channels.
Sun Pharmaceutical Industries: Offers aztreonam formulations primarily for Asian markets.
Fresenius Kabi: Provides hospital-grade injectable antibiotics, including AZACTAM, with a focus on critical care settings.

Supply Chain Dynamics and Regulatory Considerations

The supply of AZACTAM hinges on manufacturing capacity, regulatory approvals, and patent landscapes. The expiration of key patents has encouraged proliferation of generic manufacturers, increasing supply diversity but also challenging patent enforcement. Regulatory bodies such as the FDA, EMA, and comparable agencies impose strict criteria, influencing which suppliers can market AZACTAM in specific regions.

Manufacturers often collaborate with contract manufacturing organizations (CMOs) to meet global demand, especially given the complexity of sterile injectable production. Industry consolidation, patent litigations, and geopolitical factors further impact supply stability. Notably, recent disruptions in the pharmaceutical supply chain—exacerbated by COVID-19—highlight the need for diversified suppliers to mitigate shortages.

Market Trends and Emerging Suppliers

Innovation in antibiotic formulations and biosynthesis techniques is shaping the future supplier landscape for AZACTAM. Synthetic biology and process optimization are enabling existing manufacturers to increase yield and reduce costs, which may strengthen supply chains.

Emerging suppliers from regions such as Southeast Asia and Africa are expanding their capacity, often supported by government initiatives aimed at improving access to essential medicines. These regional suppliers are particularly vital for national healthcare systems aiming to reduce dependency on imported formulations.

Conclusion

The supply of AZACTAM is distributed among a mix of global generic manufacturers, regional producers, and historic patent holders. Major players include Mylan (Viartis), Sandoz (Novartis), Teva, Cipla, Aurobindo, Hikma, and Fresenius Kabi, among others. The evolving patent landscape and manufacturing innovations continue to influence supply stability and market competition.

For healthcare providers and procurement strategists, understanding the diversified supplier landscape allows for better management of drug availability, cost considerations, and risk mitigation—especially in the context of supply chain disruptions and regulatory complexities.

Key Takeaways

Multiple Suppliers Ensure Supply Security: The AZACTAM market is characterized by numerous generic manufacturers, reducing dependency on a single source and promoting competitive pricing.
Regional Diversity is Critical: Regional manufacturers, especially in Asia and Africa, play vital roles in supplying AZACTAM, particularly in LMICs.
Patent Expiry Fuels Market Entry: Patent expirations have expanded the supplier base but also require vigilant regulatory compliance.
Supply Chain Resilience is Essential: Manufacturers leveraging alternative manufacturing sites and CMOs help maintain steady supplies amid disruptions.
Innovation Continues: Advances in biosynthesis and manufacturing processes are likely to influence future supply chain dynamics and costs.

FAQs

1. Who are the leading global suppliers of AZACTAM?
Major suppliers include Mylan (Viatris), Sandoz (Novartis), Teva Pharmaceutical Industries, Cipla, Hikma Pharmaceuticals, and Fresenius Kabi, each providing AZACTAM in various markets.

2. How has patent expiration affected AZACTAM supply?
Patent expiry catalyzed the entry of numerous generic manufacturers, broadening the supply base but also increasing market competition and price volatility.

3. Are there regional suppliers that dominate specific markets?
Yes, Indian companies like Cipla, Aurobindo, and Zydus Cadila dominate in Asia and some LMIC markets, while companies like Hikma serve MENA regions.

4. What role do contract manufacturing organizations play?
CMOs enable pharmaceutical companies to scale production efficiently, ensure quality standards, and respond swiftly to demand surges, thus supporting supply stability.

5. What are the future trends influencing AZACTAM supply?
Biosynthesis innovations, regulatory developments, and regional capacity expansions are expected to shape the manufacturing landscape, enhancing supply reliability and affordability.

References

[1] U.S. Food and Drug Administration. AZACTAM (aztreonam) for Injection, USP. FDA Drug Database.
[2] Market Line. Global Antibiotic Market Reports.
[3] IQVIA. Pharmaceutical Market Reports.
[4] Company Websites and Regulatory Filings from Cipla, Hikma, Aurobindo, and others.
[5] WHO. Model List of Essential Medicines.

Suppliers and packagers for AZACTAM

AZACTAM

Suppliers for the Pharmaceutical Drug: AZACTAM