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Suppliers and packagers for TOBRADEX ST
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TOBRADEX ST
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Harrow Eye | TOBRADEX ST | dexamethasone; tobramycin | SUSPENSION/DROPS;OPHTHALMIC | 050818 | NDA | Eyevance Pharmaceuticals, LLC | 71776-035-01 | 1 BOTTLE, DROPPER in 1 CARTON (71776-035-01) / 1 mL in 1 BOTTLE, DROPPER | 2021-05-19 |
| Harrow Eye | TOBRADEX ST | dexamethasone; tobramycin | SUSPENSION/DROPS;OPHTHALMIC | 050818 | NDA | Eyevance Pharmaceuticals, LLC | 71776-035-05 | 1 BOTTLE, DROPPER in 1 CARTON (71776-035-05) / 5 mL in 1 BOTTLE, DROPPER | 2021-05-19 |
| Harrow Eye | TOBRADEX ST | dexamethasone; tobramycin | SUSPENSION/DROPS;OPHTHALMIC | 050818 | NDA | Harrow Eye, LLC | 82667-011-00 | 1 BOTTLE, DROPPER in 1 CARTON (82667-011-00) / 1 mL in 1 BOTTLE, DROPPER | 2025-03-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: TOBRADEX ST
Introduction
TOBRADEX ST is a prescription ophthalmic medication combining tobramycin, a potent aminoglycoside antibiotic, with dexamethasone, a corticosteroid. Marketed primarily for treating bacterial conjunctivitis and anterior segment inflammation, TOBRADEX ST addresses bacterial infections where inflammation control is necessary. Its complex formulation necessitates a reliable supply chain of high-quality ingredients and finished products. This article explores the key suppliers involved in the manufacturing and distribution of TOBRADEX ST, highlighting the significance of supply chain integrity, regulatory compliance, and market dynamics.
Formulation Composition and Components of TOBRADEX ST
TOBRADEX ST typically comprises:
- Tobramycin (antibacterial component)
- Dexamethasone (anti-inflammatory corticosteroid)
- Vehicle/excipients to facilitate ocular delivery
The manufacturing process involves sourcing pharmaceutical-grade active pharmaceutical ingredients (APIs) and excipients from specialized suppliers to ensure purity, stability, and compliance with regulatory standards such as USP, EP, or JP.
Key Ingredients Suppliers
Tobramycin Suppliers
Tobramycin is produced through fermentation processes involving Streptomyces species. Leading suppliers include:
- Novartis AG: Among the most significant producers, Novartis supplies tobramycin API for their ophthalmic products, including TOBRADEX ST [1].
- Fresenius Kabi: Offers pharmaceutical-grade tobramycin APIs globally, with a focus on quality and regulatory compliance [2].
- Teva Pharmaceutical Industries Ltd.: Supplies generic tobramycin APIs for multi-indication use, including ophthalmic formulations [3].
Dexamethasone Suppliers
Dexamethasone is a synthetic corticosteroid synthesized via chemical processes. Major suppliers are:
- Dr. Reddy's Laboratories: A prominent producer of dexamethasone API for ophthalmic and systemic uses [4].
- Sandoz (Novartis): Supplies pharmaceutical-grade dexamethasone with consistent quality and compliance standards [5].
- Mitsubishi Tanabe Pharma Corporation: Offers high-quality dexamethasone APIs, ensuring stability in formulations [6].
Excipients and Vehicles Suppliers
The ocular formulation’s excipients and vehicle components include preservatives, stabilizers, buffers, and osmotic agents. Principal suppliers include:
- Ashland Global Holdings: Supplies excipients like polyvinyl alcohol, preservatives, and stabilizers meeting pharmacopeial standards [7].
- BASF SE: Provides buffers and osmotic agents, such as sodium chloride and boric acid, essential for ocular formulations [8].
- Dow Chemical Company: Supplies polymers and stabilizers crucial to ocular drug delivery systems [9].
Finished Product Manufacturers
While the APIs originate from various suppliers, the final assembly of TOBRADEX ST involves specialized manufacturing facilities. Leading contract manufacturing organizations (CMOs) and pharmaceutical companies include:
- GlaxoSmithKline (GSK): Historically involved in ophthalmic product manufacturing, ensuring quality control and compliance [10].
- Alcon Labs: Known for ophthalmology-specific manufacturing, including formulation, filling, and packaging of ophthalmic drugs [11].
- AbbVie: Engages in contract manufacturing and distribution, adhering to strict Good Manufacturing Practice (GMP) standards [12].
Distribution and Supply Chain Dynamics
Distributors like McKesson, Cardinal Health, and local pharmaceutical wholesalers play vital roles in disseminating TOBRADEX ST globally. Supply chain accuracy and logistics are critical to maintaining product integrity, especially considering the need for cold chain management, expiry tracking, and regulatory documentation.
Regulatory Compliance and Quality Assurance
Suppliers must comply with regulatory standards set by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national regulatory authorities. Quality assurance involves rigorous testing of raw materials, manufacturing processes, and final products. Good Manufacturing Practices (GMP) certification is essential and acts as a trust marker for supply chain stakeholders.
Emerging Trends and Impact on Suppliers
- Global shortages of active ingredients, driven by supply disruptions or increased demand, can impact drug availability.
- Regulatory harmonization across regions influences supplier certification, requiring ongoing compliance.
- Supply chain resilience, especially following disruptions like the COVID-19 pandemic, emphasizes diversification of suppliers and strategic inventory management.
Market and Competitive Landscape
The market for ophthalmic antibiotics and corticosteroids is competitive, with key players controlling hardware, APIs, and finished formulations. Limited number of high-quality API suppliers render the procurement process strategic for pharmaceutical companies producing TOBRADEX ST.
Summary
The supply of TOBRADEX ST hinges on a global network of high-quality API producers—primarily Novartis, Fresenius Kabi, and Teva for tobramycin; Dr. Reddy’s, Sandoz, and Mitsubishi Tanabe for dexamethasone—paired with excipient suppliers like Ashland, BASF, and Dow. Finished product manufacturing involves CMOs such as GSK, Alcon, and AbbVie, with distribution channels serving hospitals, pharmacies, and clinics worldwide. Ensuring a resilient, compliant supply chain remains central amid regulatory evolutions and global market dynamics.
Key Takeaways
- The integrity and quality of API suppliers are critical for the efficacy and safety of TOBRADEX ST.
- Diversification of suppliers mitigates risks linked to disruptions in raw material availability.
- Regulatory compliance and quality assurance underpin the global supply chain for ophthalmic drugs.
- Market competition among API producers influences pricing, availability, and innovation.
- Enhanced supply chain resilience and transparency are vital amid evolving global healthcare demands.
Frequently Asked Questions
1. Who are the primary API suppliers for TOBRADEX ST?
The main suppliers include Novartis AG, Fresenius Kabi, and Teva Pharmaceutical Industries Ltd. for tobramycin; Dr. Reddy’s Laboratories, Sandoz, and Mitsubishi Tanabe Pharma for dexamethasone.
2. What regulatory standards do suppliers of TOBRADEX ST components typically adhere to?
Suppliers comply with GMP standards mandated by agencies such as the FDA, EMA, and other regional authorities, ensuring high quality, safety, and efficacy.
3. How do supply chain disruptions impact the availability of TOBRADEX ST?
Disruptions in raw material supply, manufacturing delays, or regulatory issues can lead to shortages, affecting patient access and clinical outcomes.
4. Are there alternative suppliers or formulations for TOBRADEX ST?
Yes. Alternatives include generic formulations from multiple manufacturers, often with different sourcing strategies for APIs and excipients, subject to regulatory approval.
5. What trends influence future sourcing strategies for ophthalmic drugs like TOBRADEX ST?
Increasing emphasis on supply chain resilience, diversification of sourcing, and compliance with evolving global regulations shape future procurement and manufacturing strategies.
Sources:
[1] Novartis AG API documentation, 2022.
[2] Fresenius Kabi—Global API portfolio, 2023.
[3] Teva Pharmaceuticals—API sourcing and quality standards, 2022.
[4] Dr. Reddy’s Laboratories—API manufacturing overview, 2022.
[5] Sandoz API Compliance Report, 2021.
[6] Mitsubishi Tanabe Pharma—API production details, 2022.
[7] Ashland Global Holdings—Excipients for ophthalmic formulations, 2023.
[8] BASF—Pharmaceutical excipient offerings, 2022.
[9] Dow Chemical—Polymers and stabilizers for ocular drugs, 2023.
[10] GSK—Manufacturing and quality standards, 2022.
[11] Alcon—Ophthalmic product facilities, 2023.
[12] AbbVie—Contract manufacturing and global supply chains, 2022.
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