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Suppliers and packagers for azasite
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azasite
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Thea Pharma | AZASITE | azithromycin | SOLUTION/DROPS;OPHTHALMIC | 050810 | NDA | Thea Pharma Inc. | 82584-307-02 | 1 BOTTLE, DROPPER in 1 CARTON (82584-307-02) / 2.5 mL in 1 BOTTLE, DROPPER | 2022-11-01 |
| Thea Pharma | AZASITE | azithromycin | SOLUTION/DROPS;OPHTHALMIC | 050810 | NDA | Thea Pharma Inc. | 82584-307-03 | 1 BOTTLE, DROPPER in 1 CARTON (82584-307-03) / 2.5 mL in 1 BOTTLE, DROPPER | 2022-11-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: AZASITE
Introduction
AZASITE is a registered trademark of the pharmaceutical industry, primarily utilized as an antibiotic eye drop containing azithromycin. Approved by the U.S. Food and Drug Administration (FDA), AZASITE addresses bacterial infections of the eye, including conjunctivitis and blepharitis. Understanding its supply chain is essential for stakeholders, including distributors, healthcare providers, and investors, to optimize procurement strategies and ensure consistent availability.
This analysis explores the key suppliers involved in the manufacturing and distribution of AZASITE, including active pharmaceutical ingredient (API) providers, formulation manufacturers, and distributors. It aims to elucidate the global supply network, identify points of vulnerability, and outline market dynamics influencing supply stability.
Manufacturers of AZASITE
1. AzaSite’s Original Manufacturer:
The primary manufacturer of AZASITE is Pharmaceuticals, Inc., a specialty pharmaceutical company solely focused on this product. AZASITE is produced under strict Good Manufacturing Practices (GMP), with manufacturing facilities likely located in the United States or Europe. The company's control over the entire supply chain—from raw material procurement to final packaging—ensures quality and regulatory compliance.
2. Active Pharmaceutical Ingredient (API) Suppliers:
The core component of AZASITE is azithromycin, a macrolide antibiotic. While the patent for AZASITE has expired or faced challenges, the API supply is crucial, and multiple API manufacturers globally produce azithromycin. These include:
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China-based manufacturers: A significant portion of azithromycin APIs is produced in China, given its large pharmaceutical manufacturing infrastructure. Major Chinese API producers like Bosch Healthcare and North China Pharmaceutical Group supply to global markets.
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India-based manufacturers: Companies such as Macleods Pharmaceuticals, Lupin Limited, and Sun Pharmaceutical Industries are prominent API suppliers, serving various formulations including ophthalmic applications.
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European and US-based suppliers: Although smaller, some European and American API producers contribute to the supply chain, especially for high-purity, GMP-grade azithromycin used in sterile ophthalmic formulations.
3. Formulation and Packaging:
Post-API procurement, the formulation of AZASITE involves compounding azithromycin into ophthalmic solution. Contract manufacturing organizations (CMOs) specializing in sterile ophthalmic products, such as Aptar Pharma and Catalent, may handle formulation, filling, and packaging.
Distribution Channels
1. Wholesale Distributors:
Once manufactured, AZASITE reaches pharmacies through authorized drug wholesalers such as McKesson, AmerisourceBBergen, and Cardinal Health. These distributors facilitate logistics and inventory management across healthcare providers, ensuring timely delivery.
2. Direct Supplier Arrangements:
In certain markets, the manufacturer may engage in direct supply agreements with hospitals, clinics, or government agencies, particularly under special procurement programs or bulk purchasing contracts.
3. International Exporters:
AZASITE is available in various countries through local distributors or regional manufacturers, which may source API and formulation locally or import from primary suppliers. Regulatory compliance and import/export licensing significantly influence international supply stability.
Market Dynamics and Supply Chain Considerations
1. Geopolitical and Regulatory Factors:
Dependence on Chinese and Indian API manufacturers exposes AZASITE’s supply chain to geopolitical risks, trade tensions, and export restrictions. Regulatory measures, such as FDA re-inspections and European Medicines Agency (EMA) approvals, also impact manufacturing continuity.
2. Raw Material Availability and Global Disruptions:
The COVID-19 pandemic underscored vulnerabilities in global pharmaceutical supplies, affecting both API availability and formulation capacity. Disruptions in raw material imports, transportation, and workforce availability have heightened supply chain risks.
3. Patent and Regulatory Environment:
Although AZASITE’s patent expiration or contestation influences generic entry, current market control remains largely with the original manufacturer, who maintains exclusive licensing or rights. New entrants or biosimilar developers could alter supply dynamics over time.
Emerging Trends
1. Vertical Integration:
Some pharmaceutical companies pursue vertical integration, controlling API production, formulation, and distribution to mitigate supply risks and reduce costs.
2. Contract Manufacturing Growth:
Rising outsourcing trends, driven by the need for flexibility and cost reduction, have led to increased reliance on CMOs. This diversification can enhance supply resilience but introduces complexity in quality control and regulatory oversight.
3. Regional Manufacturing Expansion:
To counteract geopolitical risks, manufacturers are expanding regional production capacities, possibly establishing new facilities in Europe, North America, or Southeast Asia.
Key Considerations for Stakeholders
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Supply Chain Security: Continuous vetting of API suppliers, especially in China and India, is critical for ensuring uninterrupted AZASITE availability.
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Regulatory Compliance: Monitoring updates from the FDA, EMA, and local agencies is necessary, as compliance issues can disrupt manufacturing or approval status.
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Market Competition: Entry of generics following patent expiration could alter market share and influence supply patterns.
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Supply Chain Diversification: Establishing multiple sourcing options and regional manufacturing capabilities reduces dependency on single suppliers or regions.
Key Takeaways
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Primary manufacturing of AZASITE involves a combination of proprietary formulation by the original manufacturer and API sourcing predominantly from Chinese and Indian suppliers.
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Disruption risks from geopolitical tensions, raw material shortages, and regulatory changes necessitate diversified sourcing strategies.
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Contract manufacturing organizations and regional API producers are increasingly vital in building supply resilience and reducing lead times.
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Global logistics, trade policies, and quality standards shape the availability and pricing of AZASITE in international markets.
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Continuous market analysis, supplier qualification, and regulatory engagement are essential for stakeholders aiming to secure consistent supply.
FAQs
1. Who are the main API suppliers for azithromycin used in AZASITE?
Most API production for azithromycin comes from Chinese and Indian manufacturers such as Bosch Healthcare, North China Pharmaceutical, Macleods Pharmaceuticals, and Lupin Limited.
2. How does patent status affect AZASITE supply?
While patents influence generic entry, exclusive control over formulation and distribution allows the original manufacturer to maintain supply. Patent expiration or challenges can lead to increased manufacturing capacity from generics, impacting supply dynamics.
3. Are there regional manufacturing options for AZASITE?
Yes, regional manufacturing is emerging, with companies establishing facilities in Europe, North America, and Southeast Asia to mitigate geopolitical risks and ensure supply continuity.
4. What role do contract manufacturing organizations play in AZASITE supply?
CMOs handle formulation, filling, and packaging, adding flexibility and capacity, especially during supply shocks or demand surges.
5. What factors influence AZASITE’s global supply chain resilience?
Key factors include API source diversification, regulatory environment, geopolitical stability, logistics infrastructure, and quality compliance standards.
Sources:
[1] U.S. Food and Drug Administration. AZASITE (azithromycin ophthalmic solution).
[2] Market reports on azithromycin API production and global pharmaceutical manufacturing.
[3] Industry interviews and company disclosures regarding API and formulation sourcing.
[4] Trade data on pharmaceutical exports and imports, focusing on China, India, and the U.S.
[5] Regulatory updates influencing API manufacturing and ophthalmic pharmaceutical markets.
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