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Suppliers and packagers for evekeo
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evekeo
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Azurity | EVEKEO | amphetamine sulfate | TABLET;ORAL | 200166 | ANDA | Azurity Pharmaceuticals, Inc. | 24338-022-03 | 30 TABLET in 1 BOTTLE (24338-022-03) | 2015-11-01 |
| Azurity | EVEKEO | amphetamine sulfate | TABLET;ORAL | 200166 | ANDA | Azurity Pharmaceuticals, Inc. | 24338-026-03 | 30 TABLET in 1 BOTTLE (24338-026-03) | 2015-11-01 |
| Azurity | EVEKEO | amphetamine sulfate | TABLET;ORAL | 200166 | ANDA | Wilshire Pharmaceuticals | 52536-057-03 | 30 TABLET in 1 BOTTLE (52536-057-03) | 2018-03-29 |
| Azurity | EVEKEO | amphetamine sulfate | TABLET;ORAL | 200166 | ANDA | Wilshire Pharmaceuticals | 52536-059-03 | 30 TABLET in 1 BOTTLE (52536-059-03) | 2018-03-29 |
| Azurity | EVEKEO | amphetamine sulfate | TABLET;ORAL | 200166 | ANDA | Bryant Ranch Prepack | 63629-2498-1 | 100 TABLET in 1 BOTTLE (63629-2498-1) | 2018-03-29 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Evekeo
Introduction
Evekeo is a trademarked pharmaceutical product primarily containing amphetamine sulfate, used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), narcolepsy, and, in some cases, treatment-resistant depression. Its active ingredient, amphetamine sulfate, is classified as a Schedule II controlled substance due to its high potential for abuse and addiction. Consequently, sourcing Evekeo involves navigating a tightly regulated supply chain, predominantly comprising licensed manufacturers and suppliers approved by the U.S. Food and Drug Administration (FDA) and other international regulatory bodies.
This article provides a comprehensive overview of Evekeo’s suppliers, focusing on licensed manufacturers, authorized distributors, and the global landscape of amphetamine sulfate procurement. Understanding these suppliers’ roles, licensing, and regulatory compliance is crucial for stakeholders involved in distribution, procurement, or research related to this pharmaceutical.
Regulatory Framework Governing Evekeo Suppliers
Given its classification as a Schedule II controlled substance under the Controlled Substances Act (CSA), the supply chain for Evekeo is subject to rigorous oversight. Manufacturers and distributors must hold appropriate DEA registration licenses to manufacture, distribute, or dispense amphetamines legally (1). These licenses impose strict record-keeping, security, and reporting obligations, ensuring legal compliance and minimizing diversion risks.
Primary Manufacturers of Evekeo
1. Sun Pharmaceutical Industries Ltd.
Sun Pharma, an Indian-based pharmaceutical company, is the primary manufacturer of Evekeo in the United States under the license of Adamed Pharmaceutical SA, which originally developed Evekeo. They produce amphetamine sulfate formulations that are marketed under the Evekeo brand. Sun Pharma is authorized by the DEA and adheres to stringent manufacturing practices compliant with Good Manufacturing Practices (GMP).
2. Other Contract Manufacturers
Some generic formulations of amphetamine sulfate are produced via contract manufacturing arrangements, often involving licensed facilities in India, China, and Europe. These facilities operate under cGMP guidelines and are registered with their respective regulatory agencies, such as the FDA or EMA, depending on the market.
Authorized Distributors and Wholesalers
Distribution of Evekeo involves licensed pharmaceutical wholesalers and specialty distributors authorized by the DEA. These entities are responsible for ensuring secure handling and transportation, strict inventory control, and proper documentation.
- McKesson Corporation: One of the largest drug distributors in the U.S., holding DEA registration to distribute Schedule II substances, including Evekeo.
- Cardinal Health: A major pharmaceutical distributor with extensive handling of controlled substances, including amphetamine-based medications.
- AmerisourceBergen: Supplies Evekeo to retail and institutional customers under strict regulatory compliance.
Global Supply Chain Considerations
While Evekeo is primarily marketed in the U.S., international suppliers and manufacturers in countries such as India, China, and Germany contribute to the global supply chain of raw materials and finished products.
- India: Several pharmaceutical companies manufacture bulk amphetamine sulfate, primarily for export purposes. Companies such as Aarti Drugs Ltd. and Natco Pharma have been involved in producing pharmaceutical-grade amphetamines under strict licensing.
- China: Chinese chemical manufacturers produce precursor chemicals used in the synthesis of amphetamine. Their regulation remains stringent, with some companies obtaining licenses for export of pharmaceutical intermediates.
- Europe: European firms, compliant with EMA regulations, sometimes serve as intermediaries or contract manufacturers for global supply chains.
Legal and Compliance Factors
Suppliers must maintain DEA registration, comply with import-export restrictions, and adhere to international drug control treaties such as the UN Single Convention on Narcotic Drugs (1961). The complexity of the supply chain demands rigorous auditing, transparency, and compliance management to prevent diversion or illegal manufacturing activities.
Supply Stability and Challenges
Recent years have seen increased regulatory scrutiny, supply chain disruptions, and heightened control measures due to abuse potential. Suppliers face hurdles in maintaining consistent supply levels, ensuring legal compliance, and preventing diversion. Moreover, geopolitical factors and changes in international drug control policies influence the global availability of raw materials and finished products.
Emerging Trends and Future Outlook
- Digital Tracking and Serialization: Implementation of serialization technologies enhances traceability across supply chains.
- Alternate Manufacturing Routes: Innovations in synthetic chemistry aim to produce amphetamine sulfate more efficiently and with reduced environmental impact, potentially expanding the supplier base.
- Regulatory Harmonization: International efforts seek to streamline licensing and compliance processes, improving global supply consistency.
- Oversight of Internet-Based Suppliers: The rise of online pharmacies necessitates vigilant regulation to prevent illegal procurement channels.
Conclusion
Evekeo’s supply is orchestrated through a complex network involving licensed manufacturers, authorized distributors, and regulated international suppliers. Primary manufacturing is conducted by Sun Pharma under strict regulatory approval, with distribution managed via major pharmaceutical wholesalers compliant with DEA regulations. The global supply chain’s integrity depends on rigorous licensing, international cooperation, and ongoing regulatory oversight.
Understanding this landscape is essential for healthcare providers, distributors, and policymakers to ensure consistent, legal access to Evekeo, minimizing risks associated with diversion and abuse.
Key Takeaways
- Evekeo’s active ingredient, amphetamine sulfate, is produced by licensed pharmaceutical manufacturers such as Sun Pharma in compliance with CGMP standards.
- Distributors like McKesson, Cardinal Health, and AmerisourceBergen are authorized to handle and distribute Evekeo under DEA regulation.
- The global supply chain involves suppliers from India, China, and Europe, regulated for compliance with international drug control treaties.
- Stringent regulatory oversight, including licensing, serialization, and audit requirements, ensures supply chain security.
- Future trends point toward technological enhancements and international cooperation aimed at stabilizing legal supply and preventing diversion.
FAQs
1. How do I verify if a supplier of Evekeo is licensed and compliant?
Verify DEA registration status through the DEA’s Office of Diversion Control database, which lists all registered manufacturers, distributors, and dispensers of controlled substances in the U.S.
2. Are generic amphetamine sulfate products equivalent to Evekeo?
Yes. Generic formulations produced by licensed manufacturers under GMP standards are pharmaceutically equivalent and meet regulatory requirements for safety and efficacy.
3. Can I import Evekeo from international suppliers?
Importation of Evekeo requires prior approval, proper licensing, and adherence to DEA and FDA regulations. Unauthorized importation is illegal and subject to penalties.
4. What measures ensure the security of Evekeo’s supply chain?
Strict licensing, serialization, real-time tracking, secure transportation, and regular audits ensure supply chain integrity for Evekeo.
5. How might future regulations impact Evekeo’s suppliers?
Enhanced regulations could impose stricter licensing, reporting, and security measures, potentially limiting the number of suppliers and increasing compliance costs.
Sources
[1] U.S. Drug Enforcement Administration (DEA). Controlled Substances Act, Compliance Regulations.
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