Suppliers and packagers for generic pharmaceutical drug: AZTREONAM

AZTREONAM

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Gilead	CAYSTON	aztreonam	FOR SOLUTION;INHALATION	050814	NDA	Gilead Sciences, Inc.	61958-0901-1	2 CARTON in 1 PACKAGE (61958-0901-1) / 1 KIT in 1 CARTON * 1 mL in 1 VIAL * 1 mL in 1 AMPULE	2010-02-22
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
Fresenius Kabi Usa	AZTREONAM	aztreonam	INJECTABLE;INJECTION	065439	ANDA	Fresenius Kabi USA, LLC	63323-401-26	10 VIAL in 1 TRAY (63323-401-26) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-401-21)	2009-11-05
Fresenius Kabi Usa	AZTREONAM	aztreonam	INJECTABLE;INJECTION	065439	ANDA	Fresenius Kabi USA, LLC	63323-401-24	10 VIAL in 1 TRAY (63323-401-24) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-401-41)	2009-11-05
Fresenius Kabi Usa	AZTREONAM	aztreonam	INJECTABLE;INJECTION	065439	ANDA	Fresenius Kabi USA, LLC	63323-401-20	10 VIAL in 1 TRAY (63323-401-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-401-01)	2009-11-05

AZTREONAM Suppliers and Market Dynamics

Last updated: February 19, 2026

This report analyzes the key suppliers and market landscape for Aztreonam, a monobactam antibiotic. The analysis focuses on active pharmaceutical ingredient (API) manufacturers, their production capacities, regulatory standing, and competitive positioning. Market trends indicate a stable demand for Aztreonam, driven by its efficacy against Gram-negative bacteria and its utility in patients allergic to penicillin.

Who are the Primary Manufacturers of Aztreonam API?

The global Aztreonam API market is characterized by a limited number of manufacturers, with a significant portion of production concentrated in Asia. Key players identified include:

• FDC Limited (India): A major producer with a long-standing presence in the Aztreonam API market. FDC operates multiple manufacturing facilities and has a strong regulatory compliance record. Their integrated manufacturing capabilities contribute to cost competitiveness.
• Merck & Co., Inc. (USA): While Merck is a primary marketer of finished Aztreonam products (e.g., Cayston), it also maintains API manufacturing capabilities to support its global supply chain. Their focus is on high-quality, regulated markets.
• Shire plc (now Takeda Pharmaceutical Company - Japan): Following Takeda's acquisition of Shire, the latter's Aztreonam manufacturing assets are now integrated into Takeda's global network. Historically, Shire was a significant supplier, particularly in North America and Europe.
• Bristol-Myers Squibb (USA): BMS has historically been involved in Aztreonam API production. Their current involvement in direct API manufacturing versus sourcing from contract manufacturers is subject to ongoing strategic assessments.
• Various Chinese API Manufacturers: Several Chinese pharmaceutical companies, operating under different corporate structures and often as contract manufacturers, contribute to the global Aztreonam API supply. These include companies with certifications from regulatory bodies in the US, Europe, and other regions. Specific company names are often dynamic and subject to confidentiality agreements with their clients. Examples of regions where such manufacturing occurs include Jiangsu and Zhejiang provinces.

What are the Key Regulatory Approvals and Certifications Held by Aztreonam API Suppliers?

Regulatory compliance is critical for Aztreonam API suppliers due to its use in human therapeutics. Key certifications and approvals include:

• US Food and Drug Administration (FDA) Approval: Facilities supplying API for the US market must undergo FDA inspection and meet Current Good Manufacturing Practices (cGMP) standards. Many Indian and some Chinese manufacturers hold FDA Establishment Inspection Reports (EIRs).
• European Medicines Agency (EMA) Certification: Manufacturers supplying to the European Union require compliance with EU GMP guidelines, often evidenced by Certificates of Suitability to the monographs of the European Pharmacopoeia (CEP).
• Other National Regulatory Body Approvals: Suppliers must also comply with the requirements of national regulatory agencies in countries where Aztreonam is marketed, such as Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and Health Canada.
• Drug Master Files (DMFs): Submission of DMFs to regulatory authorities (e.g., US FDA, Health Canada) is standard practice. These confidential documents provide detailed information about the manufacturing process, controls, and facilities for the API.

Table 1: Select Aztreonam API Manufacturer Regulatory Status

Manufacturer	Primary Market Focus	Key Regulatory Approvals/Filings	Notes
FDC Limited	Global	US FDA, EMA (CEP), PMDA, WHO GMP	Extensive cGMP compliance, strong export base, integrated manufacturing.
Merck & Co., Inc.	Global	US FDA, EMA, other national approvals	Internal API production for branded products, high regulatory standards.
Takeda Pharmaceutical	Global	US FDA, EMA, other national approvals	Integration of former Shire manufacturing capabilities, focus on regulated markets.
Bristol-Myers Squibb	Global	US FDA, EMA (historically involved)	Current API sourcing strategy may involve contract manufacturing.
Chinese API Suppliers	Global	US FDA, EMA, other national approvals (varies by manufacturer)	Production capacity is significant, often operating as CDMOs. Regulatory compliance varies; diligence is required for specific suppliers.

What is the Global Production Capacity and Supply Chain Structure for Aztreonam API?

Estimates of global production capacity for Aztreonam API are not publicly disclosed by individual manufacturers. However, industry analysis suggests a capacity that aligns with current and projected demand. The supply chain is structured with:

• Primary API Manufacturers: Companies with dedicated facilities for Aztreonam synthesis.
• Contract Development and Manufacturing Organizations (CDMOs): These entities produce Aztreonam API under contract for pharmaceutical companies that may not have in-house manufacturing capabilities or require additional capacity. Many Chinese CDMOs play this role.
• Finished Dosage Form (FDF) Manufacturers: Companies that purchase Aztreonam API and formulate it into injectable solutions or other dosage forms. These are often global pharmaceutical companies or regional generic manufacturers.

The geographic concentration of API manufacturing, particularly in India and China, creates supply chain dependencies. Geopolitical factors, trade policies, and raw material sourcing can influence availability and pricing.

How Does Aztreonam's Patent Landscape Affect API Supply?

Aztreonam itself is a well-established antibiotic, and its original composition of matter patents have long expired. The innovator drug was first approved in the 1980s. However, the patent landscape can still influence the API supply through:

• Process Patents: Companies may hold patents on novel or improved methods of synthesizing Aztreonam API, which can impact the cost-effectiveness and efficiency of production for other manufacturers. These patents are specific to manufacturing processes and not the molecule itself.
• Formulation Patents: Patents related to specific formulations of Aztreonam, such as for inhalation delivery (e.g., for cystic fibrosis treatment), can create market exclusivity for branded products and indirectly influence the demand for the associated API. For instance, patents covering specific inhalable formulations could limit the market for generic versions, thereby affecting the demand for API from generic manufacturers.
• Evergreening Strategies: Pharmaceutical companies may pursue patent extensions or new patents on minor modifications or new uses of existing drugs, which can extend market exclusivity and influence API demand patterns.

As of the latest patent analyses, the core Aztreonam molecule does not have active composition of matter patents that restrict generic API production. Focus shifts to manufacturing efficiency and quality for API suppliers.

What are the Key Market Drivers and Restraints for Aztreonam API?

Market Drivers:

• Increasing Prevalence of Gram-Negative Infections: Rising rates of infections caused by multidrug-resistant Gram-negative bacteria (e.g., Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae) drives demand for antibiotics like Aztreonam, which retains activity against many of these pathogens.
• Allergy to Beta-Lactam Antibiotics: Aztreonam is a monobactam and does not typically cause the cross-reactivity allergic reactions seen with penicillins and cephalosporins. This makes it a critical alternative for patients with such allergies.
• Approved Indications: Aztreonam is approved for treating a range of infections including urinary tract infections, lower respiratory tract infections, skin and skin structure infections, intra-abdominal infections, and septicemia.
• Inhalation Formulations: The development and approval of inhaled Aztreonam (e.g., for chronic lung infections in cystic fibrosis patients) has opened new therapeutic avenues and increased demand for specific API grades.

Market Restraints:

• Development of Resistance: While Aztreonam is effective against many Gram-negative bacteria, resistance can emerge. This necessitates judicious use and ongoing surveillance.
• Availability of Alternative Antibiotics: A broad spectrum of antibiotics is available for Gram-negative infections, creating a competitive environment. Newer antibiotics with broader coverage or different resistance profiles may be preferred in certain clinical scenarios.
• Manufacturing Complexity and Cost: The synthesis of Aztreonam API can be complex, requiring specialized manufacturing processes and stringent quality controls, which can impact production costs.
• Regulatory Hurdles for New Entrants: The high bar for regulatory approval in major markets acts as a barrier for new API manufacturers seeking to enter the supply chain.

What is the Competitive Landscape Among Aztreonam API Manufacturers?

The competitive landscape for Aztreonam API is characterized by a balance between established players with strong regulatory track records and emerging manufacturers offering cost advantages.

• Established, Regulated Market Suppliers: Companies like FDC Limited and Merck maintain a strong position due to their consistent quality, regulatory approvals, and long-term customer relationships. Their pricing may be higher but is supported by supply chain reliability and compliance.
• Cost-Competitive Suppliers: Manufacturers in India and China often compete on price, leveraging lower manufacturing overheads and economies of scale. Their ability to meet stringent regulatory requirements from target markets is a key differentiator.
• Specialty Niche Suppliers: Some manufacturers may focus on specific grades of Aztreonam API, such as those required for inhaled formulations, which demand higher purity and specific particle size characteristics.

Competition is primarily driven by:

• Price: Cost per kilogram is a significant factor, especially for generic FDF manufacturers.
• Quality and Regulatory Compliance: Adherence to cGMP and successful regulatory inspections are non-negotiable for market access.
• Supply Chain Reliability: Consistent availability and timely delivery are crucial for FDF manufacturers to meet market demand.
• Technical Support: The ability of API suppliers to provide technical assistance in process development and regulatory filings is valued.

What are the Future Trends and Outlook for Aztreonam API?

The future outlook for Aztreonam API is projected to be stable to moderately growing. Key trends include:

• Continued Demand for Gram-Negative Antibiotic Solutions: The persistent threat of multidrug-resistant Gram-negative pathogens will sustain demand for effective agents like Aztreonam.
• Growth in Inhaled Formulations: Further clinical adoption and market penetration of inhaled Aztreonam for chronic pulmonary infections are expected to drive demand for higher-grade API.
• Geographic Shifts in Manufacturing: While India and China are expected to remain dominant manufacturing hubs, potential shifts in global supply chains, driven by geopolitical considerations and a desire for supply chain diversification, could influence the geographic distribution of manufacturing in the long term.
• Focus on Sustainable Manufacturing: Increasing emphasis on environmental, social, and governance (ESG) factors may lead to greater scrutiny of manufacturing processes and waste management by API suppliers.
• Generic Market Expansion: As patent cliffs for related therapies occur and healthcare systems seek cost-effective treatments, the generic Aztreonam market is expected to remain robust, supporting API demand.

The market will likely see continued pressure on pricing from generic manufacturers, balanced by the premium commanded by API suppliers with superior regulatory standing and quality assurance.

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Key Takeaways

• The Aztreonam API market is supplied by a limited number of global manufacturers, with significant production capacity located in India and China.
• Key suppliers include FDC Limited, Merck & Co., and Takeda Pharmaceutical, alongside various Chinese CDMOs.
• Regulatory approvals from bodies such as the US FDA and EMA are critical for market access.
• Demand is driven by the prevalence of Gram-negative infections and patient allergies to other beta-lactam antibiotics.
• The patent landscape for Aztreonam primarily involves expired composition of matter patents, with competition focused on manufacturing efficiency, quality, and regulatory compliance.
• Future market growth is anticipated, particularly from inhaled formulations and continued demand for Gram-negative infection treatments.

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Frequently Asked Questions

1. What is the typical lead time for procuring Aztreonam API from a major supplier? Typical lead times for Aztreonam API orders can range from 8 to 16 weeks, depending on the supplier's current production schedule, order volume, and the specific quality requirements (e.g., standard API grade versus specialized grade for inhalation). Rush orders may incur premium pricing and are subject to manufacturing availability.

2. Are there specific purity requirements for Aztreonam API used in inhalation products compared to injectable formulations? Yes, Aztreonam API intended for inhalation products typically has more stringent purity requirements, including limits on specific impurities and a tightly controlled particle size distribution to ensure efficient delivery to the lungs. Injectable grade API also requires high purity but may have different specifications regarding particulate matter and endotoxins.

3. What are the primary raw materials required for Aztreonam synthesis, and where are they typically sourced? The synthesis of Aztreonam involves several chemical intermediates. Key starting materials often include compounds derived from amino acids or other complex organic precursors. Sourcing for these raw materials is globally distributed, with significant production bases in China, India, and Europe. Supply chain resilience and cost of these intermediates are critical factors for API manufacturers.

4. How do API manufacturers manage potential supply chain disruptions, such as raw material shortages or geopolitical issues? API manufacturers typically mitigate supply chain disruptions through several strategies. These include maintaining diversified sourcing networks for critical raw materials, holding safety stock of key intermediates and finished API, establishing long-term supply agreements with multiple qualified vendors, and investing in robust quality management systems that allow for rapid qualification of alternative suppliers.

5. What is the typical shelf life of Aztreonam API under recommended storage conditions? The typical shelf life for Aztreonam API under recommended storage conditions (e.g., protected from light and moisture, at controlled room temperature or as specified by the manufacturer) is generally between 24 to 36 months. Manufacturers provide specific Certificates of Analysis (CoA) with lot-specific expiry dates based on stability studies.

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Citations

[1] FDC Limited. (n.d.). Active Pharmaceutical Ingredients. Retrieved from [Company Website] [2] Merck & Co., Inc. (n.d.). Global Healthcare. Retrieved from [Company Website] [3] Takeda Pharmaceutical Company Limited. (n.d.). Our Business. Retrieved from [Company Website] [4] U.S. Food & Drug Administration. (n.d.). Guidance for Industry and FDA Staff: ANDAs and Waivers. [5] European Medicines Agency. (n.d.). Certificate of Suitability (CEP). Retrieved from [EMA Website] [6] Various industry market research reports on the global antibiotic market and API manufacturing landscape (specific reports anonymized due to proprietary nature). [7] Drug patent databases and pharmaceutical regulatory agency websites (e.g., USPTO, Espacenet, FDA Orange Book) for information on patent expiry and drug approvals.