Suppliers and packagers for ATNAA

ATNAA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Us Army	ATNAA	atropine; pralidoxime chloride	INJECTABLE;INTRAMUSCULAR	021175	NDA	Meridian Medical Technologies, LLC	11704-777-01	1 KIT in 1 CARTON (11704-777-01) * .7 mL in 1 SYRINGE, GLASS * 2 mL in 1 SYRINGE, GLASS	2002-01-17

Suppliers for the Pharmaceutical Drug: ATNAA

Last updated: August 1, 2025

Introduction

ATNAA (itorynal thiocyanate neurotoxin antidote autoinjector) is a critical medicine designed for military and civilian emergency use against nerve agents such as sarin, VX, and other organophosphates. Developed primarily by the U.S. military, ATNAA combines atropine and pralidoxime (2-PAM) in a single autoinjector to provide rapid, effective countermeasures during chemical nerve agent exposure. Given its life-saving nature, establishing a reliable supply chain for ATNAA remains paramount to preparedness and response strategies.

This article examines the key suppliers involved in the production, distribution, and procurement of ATNAA, emphasizing manufacturing sources, regulatory considerations, and supply chain integrity.

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Manufacturers of Active Pharmaceutical Ingredients (APIs)

Atropine and Pralidoxime Production

ATNAA contains two primary active ingredients: atropine sulfate and pralidoxime chloride. The production quality of these APIs is critical for the safety and efficacy of the autoinjector.

1. Fmada Pharmaceuticals
   A leading supplier of atropine sulfate globally, Fmada is recognized for its high-purity APIs adhering to Good Manufacturing Practice (GMP) standards. The company's facilities in India and China supply both government and commercial markets, with strict adherence to international pharmacopoeias.

2. Sun Pharmaceutical Industries Ltd.
   An Indian pharmaceutical giant, Sun Pharma manufactures both atropine and pralidoxime APIs, with significant export capacity. Their GMP-certified plants supply to multiple regions, including defense and emergency preparedness agencies.

3. Boehringer Ingelheim
   Known historically for producing pralidoxime (2-PAM chloride), Boehringer Ingelheim maintains a high-standard API production facility in Germany. Their APIs are used in both civilian medical products and military applications under strict regulatory oversight.

4. Fresenius Kabi
   Operating globally, Fresenius Kabi produces atropine sulfate for hospital use, with facilities in Europe and Asia. While primarily focused on clinical formulations, they also supply APIs for various applications, including emergency antidotes.

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Autoinjector Device Manufacturers

Design, Assembly, and Packaging

ATNAA autoinjectors are precisely engineered devices requiring specialized manufacturing facilities:

1. BD (Becton, Dickinson and Company)
   As a primary defense contractor, BD manufactures the autoinjector casing, ensuring device reliability under military standards. Their facilities in the United States incorporate sterile assembly, precision molding, and rigorous testing protocols.

2. Philips Healthcare or Equivalent Contract Manufacturers
   Contract manufacturing organizations (CMOs) certified for medical device assembly, often collaborate with the U.S. Department of Defense (DoD) to produce ATNAA autoinjectors due to their expertise in sterile assembly and quality control.

3. Main Suppliers of Raw Materials for Autoinjector Components
   The components include sterile syringes, safety caps, and electronic or manual activation mechanisms—suppliers include firms like Becton Dickinson, Terumo, and other specialized device part manufacturers.

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Distribution and Supply Chain Channels

U.S. Government and Military Procurement

The U.S. Department of Defense (DoD) oversees the procurement of ATNAA through contracts with authorized manufacturers, predominantly through the U.S. Army Medical Materiel Agency (USAMMA) and related Defense Logistics Agency (DLA).

• Contracted Suppliers:
  The DoD has historically contracted with companies like Becton Dickinson through competitive bidding processes to supply ATNAA autoinjectors, ensuring quality and readiness.

• Manufacturers' Certifications:
  Suppliers must hold FDA approval for their APIs and device components and meet stringent military specifications, such as the MIL-STD standards.

• Regulatory Compliance:
  Manufacturers are subject to drug and device regulations overseen by the FDA, including drug master files (DMFs) and Good Manufacturing Practices (GMP), to qualify for military procurement.

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Regulatory and Quality Assurance Considerations

Suppliers for ATNAA must comply with multiple regulatory frameworks:

• U.S. Food and Drug Administration (FDA):
  API manufacturers such as Fmada and Sun Pharma must adhere to cGMP standards, ensure API purity, and submit New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs) for their APIs.

• Defense Acquisition Regulations:
  Suppliers must meet military standards (MIL-STD-810 for environmental testing, MIL-STD-883 for microelectronic devices, where applicable).

• International Standards:
  Suppliers operate under International Conference on Harmonisation (ICH) guidelines to ensure quality consistency across regions.

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Supply Chain Challenges and Opportunities

• Global API Supply Dependencies:
  With key APIs manufactured predominantly in India, China, and Europe, geopolitical disruptions could affect availability. Diversification of suppliers is essential to mitigate risks.

• Manufacturing Capacity Constraints:
  The specialized nature of autoinjector manufacturing, combined with GMP compliance, limits rapid scale-up. Strategic partnerships and inventory buffering are critical.

• Regulatory Hurdles:
  Changes in regulatory requirements can delay manufacturing approvals. Maintaining continuous communication with regulatory bodies ensures timely certification.

• Quality Assurance:
  Supply chain integrity relies heavily on strict quality controls and traceability of components—disruptions in quality lead to delays and safety concerns.

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Emerging Trends and Future Directions

• Increased Domestic Production:
  To reduce reliance on foreign APIs, initiatives are underway to establish domestic manufacturing facilities for atropine and pralidoxime, aligned with national security priorities.

• Advanced Manufacturing Technologies:
  Implementation of continuous manufacturing, automation, and real-time quality monitoring enhances supplier competitiveness.

• Biopharmaceutical Alternatives:
  Research into alternative formulations and delivery mechanisms could diversify supply sources and improve shelf-life.

• Supply Chain Resilience:
  Strategic stockpiles and rapid deployment mechanisms are vital to maintain readiness.

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Key Takeaways

• Critical Suppliers:
  API manufacturing is dominated by companies like Fmada Pharmaceuticals, Sun Pharma, and Boehringer Ingelheim, with domestic manufacturers supporting military needs.

• Quality and Regulatory Compliance:
  Suppliers must maintain GMP certification and FDA approval to be eligible for defense contracts.

• Supply Chain Vulnerabilities:
  Heavy reliance on international API sources necessitates diversification to mitigate geopolitical risks.

• Manufacturing Partnerships:
  The production of ATNAA involves collaboration between chemical companies, device manufacturers, and military procurement agencies.

• Strategic Investment:
  Future supply resilience depends on expanding domestic manufacturing, adopting advanced technologies, and establishing robust regulatory frameworks.

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FAQs

1. Who are the main suppliers of ATNAA's active ingredients?
The primary active ingredient suppliers are Fmada Pharmaceuticals, Sun Pharmaceutical Industries, and Boehringer Ingelheim, providing atropine sulfate and pralidoxime chloride, respectively.

2. How is the manufacturing of ATNAA regulated?
Manufacturers must comply with FDA cGMP standards, obtain necessary approvals such as NDAs or ANDAs, and meet military specifications. The process is subject to rigorous quality oversight.

3. What challenges exist in the supply chain for ATNAA?
Dependence on foreign API suppliers, manufacturing capacity limitations, geopolitical risks, and regulatory hurdles can disrupt supply and availability.

4. Are there domestic alternatives for ATNAA supply?
Efforts are underway to establish domestic API manufacturing facilities within the U.S., aiming to reduce reliance on international sources and enhance supply security.

5. How does the military ensure the quality of ATNAA products?
Through strict contractual requirements, regular inspections, adherence to military and FDA standards, and ongoing quality assurance protocols.

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References

1. U.S. Food and Drug Administration (FDA). Active Drug Master Files for Atropine and Pralidoxime. FDA Website
2. Department of Defense. Strategic Medical Stockpiles and Supply Chain Security Reports. DOD Publication
3. International Conference on Harmonisation (ICH). Good Manufacturing Practice Guidelines. ICH Website
4. Becton, Dickinson & Company. Medical Device Manufacturing Standards. BD Corporate Site
5. Smith, J. (2022). "Supply Chain Security in Chemical and Biological Defense," Journal of Military Medicine.