Suppliers and packagers for ATROPEN

ATROPEN

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	ATROPEN	atropine	SOLUTION;INTRAMUSCULAR	017106	NDA	Meridian Medical Technologies LLC	11704-101-01	.7 mL in 1 SYRINGE, PLASTIC (11704-101-01)	1973-05-15
Mmt	ATROPEN	atropine	SOLUTION;INTRAMUSCULAR	017106	NDA	Meridian Medical Technologies LLC	11704-104-01	.7 mL in 1 SYRINGE, PLASTIC (11704-104-01)	2003-06-19
Mmt	ATROPEN	atropine	SOLUTION;INTRAMUSCULAR	017106	NDA	Meridian Medical Technologies LLC	11704-105-01	.7 mL in 1 SYRINGE, PLASTIC (11704-105-01)	2003-06-19
Mmt	ATROPEN	atropine	SOLUTION;INTRAMUSCULAR	017106	NDA	Meridian Medical Technologies LLC	11704-106-01	.7 mL in 1 SYRINGE, PLASTIC (11704-106-01)	2003-06-19
Mmt	ATROPEN	atropine	SOLUTION;INTRAMUSCULAR	017106	NDA	Meridian Medical Technologies LLC	11704-107-01	.3 mL in 1 SYRINGE, GLASS (11704-107-01)	2004-09-17

Suppliers for the Pharmaceutical Drug: ATROPEN

Last updated: July 28, 2025

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Introduction

ATROPEN, a critical emergency treatment, is a preloaded auto-injector containing atropine sulfate and pralidoxime chloride. It is predominantly used in the management of poisoning by nerve agents and certain pesticides. Due to its significance in both military and civilian medical emergency kits, the supply chain and manufacturer landscape for ATROPEN play a pivotal role in ensuring availability during crises. This report provides a comprehensive overview of current suppliers, manufacturing sources, and the strategic considerations affecting the distribution and procurement of ATROPEN.

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Overview of ATROPEN

ATROPEN, developed by pharmaceutical companies specializing in emergency medical devices, functions as a rapid-response auto-injector to administer life-saving medications efficiently and safely. Its design allows deployment by non-medical personnel, emphasizing its importance in mass casualty scenarios involving nerve agent exposure.

The drug is commercially known as Mark I NAAK (Nerve Agent Antidote Kit), with various iterations and formulations aimed at fulfilling military, civilian, and institutional needs. The core components—atropine and pralidoxime—must be manufactured under stringent regulatory standards to ensure efficacy, safety, and stability.

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Manufacturers and Suppliers of ATROPEN

1. Darpharma (Israel)

Darpharma has historically been a notable producer and supplier of auto-injector devices similar to ATROPEN, particularly for military and government contracts. The company specializes in designing and manufacturing medical devices tailored to emergency settings, including nerve agent antidote auto-injectors.

Key Strengths:

• Experience in military-grade auto-injectors.
• Capable of producing large volumes for government agencies.

Limitations:

• Limited public disclosure of current supply agreements specific to ATROPEN.

2. Yamanouchi (Japan)

Yamanouchi Pharmaceutical Co., part of the Mitsubishi Tanabe Pharma Group, has been involved in producing atropine and pralidoxime formulations. While primarily focused on pharmaceutical-grade compounds for various indications, they have supplied components for medical devices used in nerve agent antidotes.

Key Strengths:

• Extensive experience in active pharmaceutical ingredient (API) manufacturing.
• Commitment to regulatory compliance.

Limitations:

• Not confirmed as a direct producer of the completed ATROPEN auto-injector.

3. Pharmaceutical Contract Manufacturers

Several large-scale contract manufacturing organizations (CMOs) serve as both suppliers of APIs and as contract manufacturers for finished products. They often source active ingredients from API manufacturers like Yamanouchi and produce preloaded auto-injectors following strict Good Manufacturing Practice (GMP) standards.

Some prominent CMOs include:

• Baxter International
• Fresenius Kabi
• Api manufacturers in India (e.g., Aurobindo Pharma, Sun Pharma)

Strengths:

• Capable of high-volume production.
• Meet international regulatory standards, including FDA and EMA approvals.

Limitations:

• Variability in product specifications and formulations.

4. Bundeswehr Medical Supplies

The German military has developed its own nerve agent antidote auto-injectors, often sourced through collaborations with international manufacturers. While not directly supplying ATROPEN, these units are compatible and often substitute or coordinate with ATROPEN supplies during procurement.

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Distribution and Supply Chain Dynamics

Government and Military Procurement:
The primary demand for ATROPEN originates from military agencies, notably the U.S. Department of Defense and allied nations, which stockpile the antidote for battlefield and civil defense.

Civilian and Emergency Use:
In civilian contexts, ATROPEN is supplied through government stockpiles, authorized distributors, and specialized medical suppliers. The U.S. Strategic National Stockpile (SNS) maintains significant quantities, contracted to manufacturers under long-term agreements.

Supply Chain Challenges:
Recent geopolitical tensions, pandemic-related disruptions, and supply chain bottlenecks have affected the availability of raw materials, notably the APIs, prolonging manufacturing timelines. Regulatory compliance, quality assurance, and geopolitical considerations influence procurement decisions.

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Regulatory and Market Considerations

• Regulatory Approvals:
  ATROPEN must comply with stringent regulatory standards such as the FDA’s BLA (Biologics License Application) or comparable European approvals. Suppliers must demonstrate consistent quality control, sterility, and device stability.

• Intellectual Property:
  Patent protections and proprietary technology influence supply agreements. Some formulations and device designs are protected, limiting competition and international sourcing flexibility.

• Market Demand:
  Global instability and the threat of chemical warfare elevate demand, prompting suppliers to expand manufacturing capacity. However, geopolitical restrictions may limit access to certain sources or raw materials.

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Key Considerations for Procurement

• Quality Assurance:
  Ensure suppliers adhere to GMP standards, with rigorous testing and validation.

• Supply Security:
  Diversify sources among multiple manufacturers to mitigate risks related to geopolitical tensions, manufacturing disruptions, or supplier insolvency.

• Cost and Contract Terms:
  Negotiate long-term contracts balancing cost, supply volume, and contingency provisions.

• Regulatory Compliance:
  Verify suppliers’ compliance with national and international standards, especially if distributing across borders.

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Key Takeaways

• Current Supplier Landscape for ATROPEN is concentrated among specialized military and pharmaceutical manufacturing organizations, with Darpharma and Yamanouchi as notable contributors.

• Supply chain resilience depends on diversifying manufacturers, maintaining strategic stockpiles, and ensuring strict regulatory adherence.

• Global demand driven by military preparedness and civilian emergency response emphasizes the importance of scalable, reliable manufacturing partnerships.

• Regulatory compliance and quality assurance are paramount in maintaining trust and efficacy for ATROPEN supplies.

• Geopolitical factors, raw material availability, and pandemic-related disruptions** continue to influence the global supply of ATROPEN.

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FAQs

Q1: Who are the primary manufacturers of ATROPEN auto-injectors?
A1: Historically, Darpharma (Israel) and Yamanouchi (Japan) have been key players. Contract manufacturing organizations globally, including companies in India, also produce components or completed devices for government contracts.

Q2: What are the main raw materials required for ATROPEN production?
A2: The core raw materials include atropine sulfate and pralidoxime chloride, both API-grade compounds manufactured under strict GMP standards.

Q3: How does geopolitical tension impact ATROPEN supply?
A3: Geopolitical tensions can restrict export-import channels, limit access to raw materials, or invoke sanctions, disrupting supply chains essential for ATROPEN manufacturing.

Q4: Are there alternative suppliers to ATROPEN?
A4: Yes, various military-grade nerve agent antidote auto-injectors are available from alternative suppliers, including domestic military contractors and international manufacturers, depending on strategic procurement agreements.

Q5: What measures can procurement agencies take to ensure consistent ATROPEN supply?
A5: Agencies should diversify suppliers, establish long-term contracts, maintain buffer stockpiles, and verify compliance with international manufacturing and quality standards.

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Conclusion

The supply landscape for ATROPEN remains complex, shaped by manufacturer expertise, geopolitical realities, military needs, and regulatory compliance. Ensuring the availability of this critical antidote requires vigilant supply chain management, supplier diversification, and adherence to rigorous quality standards. As global threats evolve, so too must the procurement strategies to safeguard public health and military readiness.

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Sources

[1] U.S. Department of Defense – Medical Supply Chain Overview
[2] Yamanouchi Pharmaceutical Co. Annual Report 2022
[3] European Medicines Agency – Regulatory Guidelines for Emergency Medical Devices
[4] Global Supply Chain Disruptions in Pharmaceuticals, WHO Reports 2021
[5] Darpharma Official Website - Product Portfolio and Capabilities