Share This Page
Suppliers and packagers for ATROPINE (AUTOINJECTOR)
✉ Email this page to a colleague
ATROPINE (AUTOINJECTOR)
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Rafa Labs Ltd | ATROPINE (AUTOINJECTOR) | atropine | SOLUTION;INTRAMUSCULAR | 212319 | NDA | Rafa Laboratories, Ltd. | 71053-592-01 | 480 CARTON in 1 BOX (71053-592-01) / 40 SYRINGE in 1 CARTON / .7 mL in 1 SYRINGE | 2018-07-09 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ATROPINE (AUTOINJECTOR)
Introduction
Atropine autoinjectors are vital emergency medications used primarily for treating severe bradycardia, asystole, and poisoning from nerve agents or pesticides. Their rapid administration capability makes them indispensable in medical emergencies and military defense strategies. The procurement of high-quality atropine autoinjectors necessitates understanding the landscape of reliable suppliers, including manufacturers, distributors, and branded product providers. This analysis explores the key players involved in supplying atropine autoinjectors globally, their market positioning, regulatory considerations, and future outlook.
Manufacturers of Atropine Autoinjectors
1. Sanofi (Daiichi Sankyo) – AtroPen
Sanofi, in partnership with Daiichi Sankyo, manufactures the AtroPen, a pre-filled autoinjector designed for rapid intramuscular administration of atropine sulfate. The product primarily targets emergency medical and military markets, especially within countries emphasizing biodefense preparedness. Sanofi’s global supply chain ensures widespread availability, supported by their extensive distribution network and regulatory expertise.
2. Teva Pharmaceutical Industries Ltd.
As one of the largest generic drug manufacturers worldwide, Teva supplies atropine in various formulations, including autoinjectors and prefilled syringes. Their manufacturing facilities in Israel, the United States, and Europe adhere to rigorous quality standards. Teva has expanded its portfolio to include atropine autoinjectors tailored for military and civilian emergency services, emphasizing quick availability and regulatory compliance.
3. Vektor State Research Center of Virology and Biotechnology (Russia)
Vektor produces atropine-based autoinjectors primarily for Russian military and emergency medical sectors. Their products are characterized by cost-effectiveness and robust performance, though limited distribution outside Russia restricts their international supplier status.
4. Other Regional and Specialty Manufacturers
- Bausch+Ströbel and Ypsomed: These European companies provide manufacturing equipment and contract manufacturing services for atropine autoinjectors, enabling other pharmaceutical companies to develop their own branded products.
- Military-Grade Suppliers: Several defense contractors, especially within the United States, supply specialized atropine autoinjectors for military use, often under government contracts and with custom specifications.
Key Distributors and Supply Chain Dynamics
Given the critical nature of atropine autoinjectors, distribution channels involve pharmaceutical wholesalers, government procurement agencies, and specialized medical supply companies:
- McKesson Corporation: A major US distributor, McKesson supplies atropine autoinjectors through hospital and emergency response channels.
- AmerisourceBergen: Handles procurement and distribution of atropine products for emergency preparedness agencies.
- Government Stockpiles and Strategic National Stockpile (SNS): In countries like the US, the SNS maintains stocks of atropine autoinjectors, ensuring rapid deployment during biological or chemical threats. Suppliers like DynPort Vaccine Company and others support these stockpiles.
Regulatory Considerations and Approvals
Suppliers must adhere to stringent regulatory standards, including:
- FDA (Food and Drug Administration): For products marketed in the United States, atropine autoinjectors require premarket approval, ensuring safety, efficacy, and manufacturing quality.
- EMA (European Medicines Agency): European suppliers must obtain authorization for marketing and distribution throughout the European Union.
- Russian FDA and Local Regulations: Vektor’s products are certified under Russian health authorities, with limited international approval.
Compliance with Good Manufacturing Practices (GMP) and device-specific regulations (e.g., for autoinjector safety mechanisms) is imperative for global suppliers seeking to expand their market footprint.
Market Trends and Future Outlook
The demand for atropine autoinjectors is driven by increasing biological threats, chemical hazard preparedness, and emergency medical protocols. Rising investments in biodefense by governments, particularly in the United States, Europe, and Russia, bolster the market.
Emerging trends include:
- Product Innovation: Development of multi-agent autoinjectors that combine atropine with oximes or pralidoxime for better efficacy.
- Regulatory Expansion: Companies seek approvals in emerging markets, providing access to atropine autoinjectors where biodefense infrastructure grows.
- Manufacturing Capacity Expansion: Firms are investing in high-volume manufacturing to meet global emergency preparedness needs.
Manufacturers like Sanofi and Teva are positioned to capitalize on these trends, given their existing regulatory approvals and extensive distribution channels.
Challenges in Supply and Procurement
- Regulatory Barriers: Variability in approval processes complicates global distribution.
- Supply Chain Disruptions: Pandemic-related logistical issues impact manufacturing and distribution capabilities.
- Stockpile Management: Ensuring that existing stocks remain effective over time demands robust inventory management and shelf-life monitoring.
To mitigate such challenges, collaboration among manufacturers, governments, and international agencies is essential to ensure supply stability.
Key Takeaways
- Leading manufacturers of atropine autoinjectors include Sanofi (Daiichi Sankyo) and Teva, with regional players like Vektor supplementing supply.
- Distribution networks are primarily managed via pharmaceutical wholesalers, government agencies, and military procurement channels.
- Regulatory compliance remains a critical gatekeeper, influencing market access and product availability.
- Market growth is driven by increasing biodefense investments and emergency response needs.
- Innovation and manufacturing scalability are key to addressing future demands, especially amid geo-political and health crises.
FAQs
1. Who are the primary suppliers of atropine autoinjectors globally?
Major global suppliers include Sanofi (Daiichi Sankyo), Teva Pharmaceuticals, and regional manufacturers like Vektor in Russia. These companies provide products both for civilian emergency use and military applications.
2. What regulations govern the sale of atropine autoinjectors?
In the US, FDA approval is required, ensuring safety and efficacy. The EU mandates EMA approval, while other countries follow local health authority standards. Military and specialized suppliers may operate under strict government authorization.
3. Are there significant regional differences in supplier availability?
Yes. While Western markets predominantly rely on Sanofi and Teva, Russia’s Vektor supplies domestically, with limited international export. Emerging markets may have access through regional distributors or generic manufacturers.
4. How do supply chain disruptions impact atropine autoinjector availability?
Disruptions can cause shortages, especially given the product's critical nature in emergencies. Manufacturers and governments work to maintain strategic stockpiles and diversify sources to mitigate such risks.
5. What trends will influence the atropine autoinjector market in the coming years?
Advances in combination autoinjectors, increased biodefense funding, regulatory expansion into emerging markets, and manufacturing capacity growth will shape future supply dynamics.
Sources
[1] Sanofi. “AtroPen Autoinjector.” Sanofi Official Website.
[2] Teva Pharmaceutical Industries Ltd. Product Portfolio. Teva.com.
[3] U.S. Food and Drug Administration. “Biological Product Approvals and Regulations.” FDA.gov.
[4] European Medicines Agency. “Regulatory Procedures for Medicinal Products.” EMA.europa.eu.
[5] Global Biodefense Market Reports. MarketWatch, 2022.
More… ↓
