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Suppliers and packagers for DYANAVEL XR
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DYANAVEL XR
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Tris Pharma Inc | DYANAVEL XR | amphetamine; amphetamine aspartate/dextroamphetamine sulfate | SUSPENSION, EXTENDED RELEASE;ORAL | 208147 | NDA | NextWave Pharmaceuticals, Inc | 24478-102-01 | 1 BOTTLE in 1 CARTON (24478-102-01) / 464 mL in 1 BOTTLE | 2015-10-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: DYANAVEL XR
Introduction
DYANAVEL XR (amphetamine extended-release) is a prescription stimulant primarily used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 and older, as well as Adults. As a Schedule II controlled substance, DYANAVEL XR’s supply chain involves a complex network of manufacturers, distributors, and authorized pharmacies. This article offers an in-depth analysis of the key suppliers involved in the production and distribution of DYANAVEL XR, elucidating the current market dynamics, manufacturing landscape, and regulatory considerations that impact its supply.
Manufacturers of DYANAVEL XR
Sun Pharmaceutical Industries Ltd.
Sun Pharmaceutical Industries, a global pharmaceutical leader based in India, is the primary manufacturer of DYANAVEL XR. The company acquired rights to produce and distribute this formulation, leveraging its extensive manufacturing facilities compliant with Good Manufacturing Practices (GMP). Sun Pharma’s manufacturing sites are strategically located in India, which allows cost-effective production while maintaining high quality standards required for controlled substances.
Manufacturing Facilities
Sun Pharma’s facilities involved in the production of DYANAVEL XR are licensed by the U.S. Food and Drug Administration (FDA), ensuring compliance with stringent regulatory standards. The production process for DYANAVEL XR involves complex extended-release technology, demanding specialized equipment and expertise to ensure consistent drug release profiles.
Distribution Channels and Authorized Distributors
Major Distributors
Distribution of DYANAVEL XR is tightly regulated under U.S. Drug Enforcement Administration (DEA) controls due to its classification as a Schedule II substance. Authorized distributors include:
- McKesson Corporation
- AmerisourceBergen Corporation
- Cardinal Health
These major pharmaceutical distributors serve as intermediaries, ensuring safe logistics, storage, and distribution to licensed pharmacies and healthcare providers nationwide.
Pharmacy-Level Suppliers
Authorized retail pharmacies, including large chains like CVS Health, Walgreens Boots Alliance, and Rite Aid, directly receive DYANAVEL XR shipments through these distributors. Due to its controlled status, pharmacies must adhere strictly to inventory and record-keeping regulations, maintaining detailed logs for DEA compliance.
Supply Chain Challenges and Dynamics
Regulatory Constraints
Being a Schedule II controlled substance, DYANAVEL XR’s supply is heavily influenced by DEA regulations. These include quotas on manufacturing, strict record-keeping, and inventory controls, which aim to prevent diversion and misuse. Any changes in DEA policies or quota adjustments can impact supply availability.
Manufacturing Limitations
Limited manufacturing capacity due to the complex synthesis and extended-release technology constrains supply. Additionally, disruptions caused by raw material shortages, quality control issues, or manufacturing delays can lead to shortages or rationing in the market.
Market Demand and Prescription Patterns
Rising ADHD diagnoses and increasing awareness have driven demand, pressuring suppliers to scale up production. The COVID-19 pandemic also disrupted supply chains globally, affecting availability across multiple channels.
Regulatory and Legal Considerations
The DEA imposes strict controls on DYANAVEL XR manufacturing and distribution. Manufacturing quotas are set annually based on prescription trends and abuse potential assessments. Manufacturers and distributors must secure necessary DEA registrations and comply with regular audits.
Emerging Players and Market Competition
While Sun Pharma remains the chief producer, the demand for ADHD medications fuels competition among other generic manufacturers seeking to develop alternative formulations or biosimilars. These efforts, although nascent, could diversify the supply landscape in the future.
Geographical Supply Sources
Although primarily produced by Sun Pharma in India, the drug is imported into the U.S. under strict regulatory oversight. The supply chain also involves logistics companies specializing in handling Schedule II substances — ensuring security and compliance from manufacturing facilities to end-users.
Future Supply Outlook
With growing global ADHD prevalence and increasing awareness, demand for DYANAVEL XR is expected to rise. Continuous manufacturing capacity expansion, regulatory adjustments, and potential new entrants into the market will shape the supply landscape. Nevertheless, the complexity of manufacturing and distribution for controlled substances keeps supply somewhat constrained and susceptible to regulatory and logistical disruptions.
Conclusion
The supply chain for DYANAVEL XR is characterized by a limited number of key players, primarily Sun Pharma as the manufacturer, complemented by major pharmaceutical distributors and authorized pharmacies. The stringent DEA regulations, manufacturing complexities, and increasing demand shape the market dynamics. Businesses and healthcare providers must navigate these factors to mitigate supply shortages and ensure patient access.
Key Takeaways
- Primary Supplier: Sun Pharmaceutical Industries Ltd. is the exclusive manufacturer of DYANAVEL XR, leveraging GMP-compliant facilities primarily in India.
- Distribution Network: Managed by major distributors like McKesson, Cardinal Health, and AmerisourceBergen, which supply authorized pharmacies across the U.S.
- Regulatory Impact: DEA-controlled status imposes strict manufacturing quotas, inventory controls, and logistical requirements.
- Market Dynamics: Growing demand driven by increased ADHD diagnoses may strain current supply channels. Manufacturing capacity and global logistics are potential bottlenecks.
- Future Trends: Anticipated expansion of production capacity and potential emergence of biosimilar competitors could diversify and stabilize supply.
FAQs
1. Who is the primary manufacturer of DYANAVEL XR?
Sun Pharmaceutical Industries Ltd. is the sole manufacturer of DYANAVEL XR, producing it in accordance with regulatory standards in India and exporting to the U.S. market.
2. How is DYANAVEL XR distributed in the United States?
Distribution is facilitated through major pharmaceutical distributors—McKesson, AmerisourceBergen, and Cardinal Health—which supply authorized pharmacies under strict DEA regulations.
3. What regulations impact the supply of DYANAVEL XR?
As a Schedule II substance, its manufacture, distribution, and dispensing are governed by DEA quotas, strict record-keeping, and security protocols to prevent diversion.
4. Are there any upcoming changes in the supply landscape?
Potential increases in manufacturing capacity, new entrants developing biosimilars, and regulatory adjustments could influence future supply stability.
5. What challenges are currently impacting DYANAVEL XR supply?
Manufacturing capacity constraints, raw material shortages, regulatory quotas, and global logistics disruptions are key factors affecting supply continuity.
Sources
- U.S. Food and Drug Administration (FDA): Approved drug listing for DYANAVEL XR.
- DEA Quota Reports: Annual manufacturing quotas and control measures.
- Sun Pharmaceutical Website: Manufacturing capabilities and corporate disclosures.
- Pharmaceutical Distribution Data: Major distribution companies’ roles and logistics.
- Market Analysis Reports: Trends in ADHD medication demand and supply chain dynamics.
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