Last updated: July 29, 2025
ppliers for the Pharmaceutical Drug: ADZENYS XR-ODT
Introduction
ADZENYS XR-ODT is a prescription medication primarily indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Its formulation—an extended-release orally disintegrating tablet containing amphetamine—offers a convenient, fast-acting option for patients requiring stimulant therapy. As an increasingly popular medication within the stimulant class, understanding its supply chain, including key suppliers, is vital for stakeholders in healthcare, pharmaceutical manufacturing, and distribution networks. This analysis provides an up-to-date overview of the primary suppliers involved in the manufacturing and distribution of ADZENYS XR-ODT, considering the landscape of active pharmaceutical ingredient (API) sourcing, formulation, and packaging.
Manufacturers and Brand Context
ADZENYS XR-ODT is marketed by Sunovion Pharmaceuticals Inc., a major player in the psychiatric and neurological medication space. As a branded medication, the drug relies on a secure supply chain encompassing API production, formulation, and finished product manufacturing. While Sunovion oversees the final product, the supply chain intricacies involve multiple stakeholders, especially for the API.
API Suppliers for ADZENYS XR-ODT
The core component of ADZENYS XR-ODT is amphetamine sulfate, a controlled substance requiring stringent manufacturing controls and regulatory oversight due to its psychoactive properties.
Key API Suppliers
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Core API Manufacturer:
The primary source of pharmaceutical-grade amphetamine sulfate for licensed drugs like ADZENYS XR-ODT stems from a handful of well-established API manufacturers. Leading global suppliers include LGM Pharma, Hikal Ltd., Famar, and Sun Pharma. These companies produce high-purity amphetamine sulfate conforming to Good Manufacturing Practice (GMP) standards.
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Regulatory and Regional Considerations:
API sourcing is often region-specific owing to regulatory approvals and supply logistics. For instance, U.S.-based pharmaceutical companies predominantly source amphetamine API from domestic or approved international suppliers complying with the Drug Enforcement Administration (DEA) regulations.
Market Dynamics of API Supply
The amphetamine sulfate API market is characterized by its concentration among a limited number of producers, partly due to regulatory hurdles and the controlled substance classification. Supply disruptions, regulatory inspections, and capacity constraints at manufacturing facilities influence availability.
Formulation and Final Product Manufacturing
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Contract Manufacturing Organizations (CMOs):
Sunovion likely utilizes contract manufacturing organizations (CMOs) for the formulation, tableting, and packaging processes. Leading CMOs with experience in controlled substances include Catalent, Thermo Fisher Scientific, and Vetter Pharma. These firms possess the specialized facilities necessary for handling the controlled amphetamine API and ensuring compliance with regulatory standards.
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Formulation Components & Excipients:
Although the primary focus is the API, the formulation involves excipients such as disintegrants, binders, and fillers sourced from global suppliers like DOW, BASF, and EVA Technology. These components are critical for the disintegration profile and stability of ADZENYS XR-ODT.
Distribution and Supply Chain Partners
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Wholesale Distributors:
The finished ADZENYS XR-ODT product is distributed via large pharmaceutical wholesalers such as McKesson, AmerisourceBBIS, and Cardinal Health. These entities ensure the drug's availability across pharmacies, hospitals, and clinics.
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Pharmacy Networks:
Retail and specialty pharmacies, including chain pharmacies like CVS and Walgreens, serve as primary points of access, with distribution managed through regional and national wholesalers.
Regulatory and Compliance Considerations
Given its status as a Schedule II controlled substance, the supply chain must adhere to the Controlled Substances Act (CSA) in the U.S. and equivalent regulations worldwide. This constrains the flow of amphetamine API and the final product distribution, demanding strict record-keeping, security measures, and regular inspections.
Supply Chain Challenges and Opportunities
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Supply Security:
The concentrated API supplier base poses risks in supply continuity. Potential disruptions—such as manufacturing issues or regulatory restrictions—can impact drug availability.
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Quality Assurance:
Ensuring consistent API quality and adherence to regulatory standards is paramount. Partnerships with reputable suppliers and CMOs minimize quality-related risks.
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Market Expansion and New Entrants:
As demand for ADHD medications rises globally, opportunities exist for diversified API sourcing and manufacturing capacity expansion. Companies investing in compliant, scalable API production can capture additional market share.
Key Takeaways
- The core active ingredient for ADZENYS XR-ODT, amphetamine sulfate, is supplied by a limited number of GMP-compliant manufacturers, predominantly outside the direct control of Sunovion Pharmaceuticals.
- Contract manufacturing organizations hold a crucial role in the formulation, tableting, and packaging processes, with industry leaders like Catalent and Thermo Fisher playing significant roles.
- Distribution relies heavily on established pharmaceutical wholesalers and pharmacy networks, which are carefully managed under strict regulatory oversight due to the drug's controlled substance status.
- Supply chain vulnerabilities stem from limited API sources and regulatory constraints, necessitating ongoing risk management and strategic supplier relationships.
- Increasing global demand for ADHD treatments underscores the importance of securing diversified, compliant API supply chains and efficient manufacturing processes.
FAQs
1. Who are the main API suppliers for ADZENYS XR-ODT?
The primary amphetamine sulfate API suppliers include GMP-certified manufacturers like Hikal Ltd., Famar, and Sun Pharma, though specific sourcing details are proprietary and subject to confidentiality agreements.
2. Are there multiple manufacturers of ADZENYS XR-ODT?
Currently, ADZENYS XR-ODT is marketed by Sunovion, which manages its manufacturing through proprietary or contracted facilities, with no publicly known multiple manufacturing licenses for this specific drug. However, similar formulations are produced by other pharmaceutical companies.
3. How do regulatory restrictions affect API sourcing for this drug?
Because amphetamine sulfate is a Schedule II controlled substance, API sourcing is tightly regulated. Manufacturers must comply with DEA regulations, which limit the number of compliant suppliers and impose strict tracking and security protocols.
4. Can supply disruptions impact the availability of ADZENYS XR-ODT?
Yes. Limited API sources and stringent regulatory requirements increase vulnerability to supply chain disruptions, which could affect drug availability and manufacture schedules.
5. Are there alternative formulations or suppliers for similar ADHD medications?
Yes. Multiple pharmaceutical companies produce methylphenidate or mixed amphetamine salts formulations, providing alternative treatment options; however, differences in formulation and patent status influence supply and availability.
References
[1] Sunovion Pharmaceuticals Inc. Official Product Information.
[2] U.S. Drug Enforcement Administration (DEA). Controlled Substances Act Regulations.
[3] Market Reports on Pharmaceutical API Suppliers.
[4] Contract Manufacturing Organizations in the Pharmaceutical Sector.
[5] WHO Guidelines on Good Manufacturing Practices for Pharmaceuticals.
