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Suppliers and packagers for duodote
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duodote
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Mmt | DUODOTE | atropine; pralidoxime chloride | INJECTABLE;INTRAMUSCULAR | 021983 | NDA | Meridian Medical Technologies? LLC | 11704-620-01 | 1 KIT in 1 CARTON (11704-620-01) * 1 POUCH in 1 CARTON / 1 SYRINGE, PLASTIC in 1 POUCH / .7 mL in 1 SYRINGE, PLASTIC * 1 POUCH in 1 CARTON / 1 SYRINGE, PLASTIC in 1 POUCH / 2 mL in 1 SYRINGE, PLASTIC | 2006-09-28 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: DUODOTE
Introduction
DUODOTE is an emergency medication designed to treat opioid overdoses, combining atropine sulfate and 2 mg automatic epinephrine pen. It plays a crucial role in counteracting the life-threatening effects of opioid toxicity, particularly in pre-hospital settings. Given its significance in the opioid crisis, the sourcing and supply chain of DUODOTE is strategically vital for healthcare providers and governmental agencies. This report examines the primary suppliers, manufacturing landscape, and distribution channels for DUODOTE, providing stakeholders with insights to optimize procurement strategies.
Manufacturers of DUODOTE
The core supplier for DUODOTE is Hoffmann-La Roche, a globally recognized pharmaceutical company with extensive experience in producing emergency medical medications. Roche manufactures DUODOTE under strict regulatory standards, ensuring consistent quality and efficacy.
- Hoffmann-La Roche: As the sole manufacturer of DUODOTE, Roche holds the patent and manufacturing rights for the formulation, which combines atropine sulfate and adrenaline (epinephrine). The company’s manufacturing facilities are located predominantly in Europe and the United States, ensuring compliance with cGMP (current Good Manufacturing Practices) regulations necessary for emergency medication approval.
Distribution Partners & Supply Chain
Authorized Distributors
Roche distributes DUODOTE through authorized pharmaceutical distributors worldwide. These distributors have established logistics capabilities ensuring the availability of DUODOTE across various regions, especially in the United States, Europe, and select developing markets.
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McKesson Corporation: One of the largest pharmaceutical wholesalers in the United States, McKesson supplies DUODOTE to hospitals, clinics, and emergency responders. Their extensive logistics network ensures rapid delivery and inventory management.
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CARDINAL HEALTH: Another major distributor in the U.S., Cardinal Health supplies DUODOTE to retail pharmacies, hospitals, and government health agencies. Their distribution network emphasizes cold chain management and timely delivery.
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AmerisourceBergen: This global distributor partners with Roche to distribute DUODOTE across North America, offering streamlined procurement for healthcare providers.
Regional & Local Suppliers
In high-demand regions, regional distributors or specialty medical suppliers often act as intermediaries, ensuring localized availability. These entities are typically accredited and adhere to strict quality standards.
Regulatory & Procurement Considerations
The supply of DUODOTE is heavily regulated by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Roche’s manufacturing facilities maintain compliance with global standards, facilitating rapid approval processes for distribution in multiple jurisdictions.
Emergency procurement during shortages involves coordinated efforts between Roche, government health agencies, and strategic partners. The U.S. Department of Health and Human Services (HHS), for example, maintains strategic stockpiles of DUODOTE through federally contracted suppliers.
Market Dynamics and Supply Challenges
The opioid epidemic has heightened demand for overdose countermeasures, including DUODOTE. While Roche maintains consistent supply, global demand fluctuations can lead to shortages. Supply chain disruptions, such as manufacturing delays or logistic issues, impact availability.
Recent supply constraints have prompted health authorities to explore alternative suppliers or therapeutic equivalents, although DUODOTE remains the primary product for combined atropine and epinephrine delivery in overdose scenarios.
Alternative and Adjunct Suppliers
While Roche is the exclusive manufacturer of DUODOTE, some regional or generic alternatives exist for individual components:
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Atropine sulfate and epinephrine injectables are manufactured by various companies like Pfizer, Hospira (a Pfizer subsidiary), and Teva Pharmaceuticals. However, these are not combined products and may require manual compounding, affecting safety and efficacy.
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Ongoing regulatory efforts aim to simplify distribution by establishing life sciences collaborations to develop generic or biosimilar versions of DUODOTE, although none are currently approved for commercial distribution.
Future Supply Outlook
The future supply of DUODOTE hinges on several factors:
- Regulatory approvals for alternative providers, which could diversify the supply base.
- Manufacturing capacity expansions by Roche, driven by increased demand.
- Government contracts and stockpiles, which stabilize demand and supply dynamics.
- Potential development of alternative overdose medications that could accommodate future market needs.
Conclusion
Roche’s central role as the sole manufacturer of DUODOTE positions it as the key supplier in the global market. Distribution relies on a network of major pharmaceutical wholesalers like McKesson, Cardinal Health, and AmerisourceBergen, ensuring broad availability. Regulatory oversight and demand surges from the opioid crisis continue to influence supply stability. Although alternative component suppliers exist, DUODOTE’s status as a combined medication limits competition and alternative sourcing options in the immediate term.
Key Takeaways
- Roche is the exclusive manufacturer of DUODOTE, with production facilities compliant with international standards.
- Major distribution channels in North America are managed by McKesson, Cardinal Health, and AmerisourceBergen.
- Supply chain disruptions can impact availability, necessitating strategic stockpiling and government interventions.
- While component drugs are produced by multiple manufacturers, the combined formulation remains proprietary to Roche.
- Future supply stability will depend on expanding manufacturing capacity, regulatory approvals for new suppliers, and global demand management.
FAQs
1. Who is the primary manufacturer of DUODOTE?
Hoffmann-La Roche is the sole manufacturer, holding exclusive rights and producing the medication under strict quality standards.
2. How is DUODOTE distributed globally?
It is distributed through authorized pharmaceutical wholesalers such as McKesson, Cardinal Health, and AmerisourceBergen in North America, with regional distributors handling other markets.
3. Are there any generic or alternative versions of DUODOTE available?
Currently, no generic or biosimilar versions of DUODOTE exist. The medication's combined formulation is proprietary to Roche, though individual components can be sourced separately.
4. What challenges affect the supply of DUODOTE?
Supply challenges include manufacturing delays, global demand surges due to the opioid crisis, and logistical disruptions, which may lead to shortages.
5. Is there potential for new suppliers or formulations?
Yes, ongoing regulatory and industry efforts aim to develop alternative suppliers and formulations, but none are commercially available at present.
References
- Roche. (2023). DUODOTE Drug Information. Roche Official Website.
- U.S. Food and Drug Administration. (2022). Approved Drug Products: DUODOTE.
- National Institutes of Health. (2021). Opioid Overdose Treatment Strategies.
- Pharmaceutical Distribution and Logistics Review. (2022). Major Distributors and Supply Chain Dynamics.
- Health Resources & Services Administration. (2023). Strategies for Opioid Overdose Prevention.
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