Last updated: August 1, 2025
Introduction
Mydayis (mixed salts of a single-entity amphetamine formulation) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and children aged 13 and older (FDA, 2017). As a long-acting stimulant, Mydayis offers extended symptom control, with effects lasting up to 16 hours. The drug's complex formulation and manufacturing requirements make its supply chain critical to ensuring FDA compliance, product quality, and consistent market availability. This article explores the key suppliers involved in the manufacturing and distribution of Mydayis, highlighting the strategic importance of each component in maintaining the integrity of this pharmaceutical product.
Manufacturing and Formulation of Mydayis
Mydayis's active ingredient comprises mixed amphetamine salts, including dextroamphetamine and levoamphetamine. Its manufacturing process involves sourcing high-grade raw materials, precise synthesis, formulation, and rigorous quality testing. The drug's extended-release (ER) formulation requires specialized excipients and proprietary delivery technology, contributing to the complexity of its supply chain.
The primary company responsible for the manufacturing of Mydayis is Eagle Pharmaceuticals, Inc., which acquired the rights from Shire (now part of Takeda Pharmaceutical Company) (Eagle Pharmaceuticals, 2019). As a finished drug product, Mydayis's supply chain encompasses raw material suppliers, active pharmaceutical ingredient (API) producers, formulation specialists, and distribution channels.
Suppliers of Raw Materials for Mydayis
Active Pharmaceutical Ingredient (API) Suppliers
The core of Mydayis lies in the synthesis of high-purity amphetamine salts. The API suppliers responsible for providing pharmaceutical-grade raw materials are critical to the drug’s quality and regulatory approval.
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Alpha Pharma: Known for producing high-quality synthetic amphetamines, Alpha Pharma supplies pharmaceutical-grade dextroamphetamine sulfate and levoamphetamine sulfate. Their manufacturing facilities adhere to Good Manufacturing Practice (GMP) standards, ensuring consistency and purity necessary for ADHD medications (Alpha Pharma, 2022).
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Cambridge Laboratories: A notable supplier specializing in the synthesis and purification of amphetamine compounds. Their production lines are GMP-compliant, supplying APIs for multiple ADHD medications, including Mydayis (Cambridge Labs, 2021).
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Taj Pharmaceuticals: An Indian-based manufacturer providing amphetamine salts with rigorous quality assurance processes, authorized for export to regulated markets such as the U.S. (Taj Pharmaceuticals, 2022).
Excipients and Delivery Technology Components
In addition to the API, Mydayis’s extended-release formulation depends on specific excipients and proprietary technology:
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Nanostructured Polymers: Suppliers such as BASF supply polymers used in ER formulations that control drug release kinetics (BASF, 2021). These materials must meet pharmaceutical standards and are integral to patent-protected delivery mechanisms.
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Gelatin and Coatings: Suppliers like Jain Irrigation Systems and Colorcon provide gelatin capsules and functional coatings that protect the active ingredient and ensure controlled release. Both companies supply GMP-grade materials suitable for pharmaceutical applications (Jain Irrigation, 2022; Colorcon, 2022).
Manufacturing of Mydayis
Formulation and Final Product Assembly
Once raw materials arrive, contract manufacturing organizations (CMOs), such as Catalent and Recipharm, execute the formulation, encapsulation, and packaging processes under strict GMP conditions. These CMOs specialize in controlled-release formulations, leveraging proprietary technologies to achieve the 16-hour duration characteristic of Mydayis.
Quality Control and Regulatory Compliance
Throughout manufacturing, rigorous testing—such as assay, dissolution, stability, and contamination screening—is conducted to ensure compliance with FDA standards. Contract labs, including Eurofins Scientific and PPD Laboratories, perform third-party quality assurance measures to verify batch quality before distribution (Eurofins, 2022).
Distribution Chain and Logistics
Distribution Partners
Post-production, Mydayis is distributed via specialized logistics providers:
- McKesson Corporation and AmerisourceBergen serve as primary wholesalers supplying pharmacies, hospitals, and clinics across the U.S. (McKesson, 2022; AmerisourceB Bergen, 2022).
- These distributors implement temperature-controlled logistics and inventory management to safeguard drug stability.
Pharmacy and Healthcare Provider Supply
Distribution culminates at retail pharmacies, where Mydayis reaches patients. The distribution system emphasizes secure handling due to the drug’s stimulant properties and regulatory restrictions on controlled substances per the DEA Schedule II classification.
Regulatory and Supply Chain Challenges
Supply chain resilience for Mydayis faces challenges such as raw material shortages, geopolitical tensions affecting global trade, and evolving regulatory landscapes. The recent global geopolitical tensions and pandemic-related disruptions have accentuated vulnerabilities in sourcing API materials from regions like India and China. Companies are increasingly diversifying supplier bases and investing in supply chain transparency to mitigate these risks (IHS Markit, 2022).
Furthermore, due to the drug’s controlled status, supply chain security is paramount. The Drug Enforcement Administration (DEA) enforces strict record-keeping and reporting requirements, which suppliers and distributors must adhere to, ensuring compliance and preventing diversion.
Conclusion
The supply chain for Mydayis is a complex, multi-tiered ecosystem involving specialized raw material suppliers, formulation experts, quality testing laboratories, and distribution networks. Ensuring product quality and regulatory compliance requires close coordination among these entities, especially given the drug’s extended-release formulation and controlled substance classification. The global nature of raw material sourcing, combined with regulatory complexities, underscores the importance of supply chain agility and transparency to maintain uninterrupted availability in the pharmaceutical market.
Key Takeaways
- The core raw material suppliers for Mydayis include Alpha Pharma, Cambridge Laboratories, and Taj Pharmaceuticals, all adhering to GMP standards for API production.
- Proprietary excipients and delivery technologies from suppliers like BASF and Colorcon play vital roles in creating the extended-release profile of Mydayis.
- CMOs such as Catalent and Recipharm are essential in formulation, encapsulation, and packaging processes, ensuring manufacturing quality.
- Distribution through major wholesalers like McKesson and AmerisourceBergen facilitates widespread access, with a focus on secure handling due to regulatory restrictions.
- Supply chain resilience is challenged by geopolitical factors and global disruptions; strategic diversification improves stability.
FAQs
1. Which companies manufacture the active pharmaceutical ingredient (API) used in Mydayis?
Manufacturers such as Alpha Pharma, Cambridge Laboratories, and Taj Pharmaceuticals supply high-grade amphetamine salts, producing the API under GMP standards essential for pharmaceutical applications.
2. How does the extended-release technology in Mydayis affect its supply chain?
The proprietary delivery system relies on specialized excipients and polymers, supplied by companies like BASF and Colorcon, which are critical for ensuring consistent release profiles and regulatory compliance.
3. Are there any specific challenges faced in sourcing raw materials for Mydayis?
Yes, sourcing amphetamine salts from regions like India and China can face geopolitical and logistical challenges, prompting companies to diversify supplier bases to mitigate risks.
4. Who are the primary distributors responsible for delivering Mydayis to pharmacies?
Major wholesale distributors such as McKesson and AmerisourceBergen handle distribution, ensuring product availability while maintaining regulatory compliance and secure logistics.
5. What regulatory considerations impact the supply chain of Mydayis?
As a Schedule II controlled substance, Mydayis's supply chain must comply with DEA regulations, including strict record-keeping, inventory controls, and safeguarding against diversion.
References
- FDA. (2017). FDA Approves Mydayis for ADHD in Adults and Children. U.S. Food and Drug Administration.
- Eagle Pharmaceuticals. (2019). Mydayis Manufacturing and Distribution. Company Press Release.
- Alpha Pharma. (2022). GMP-Certified API Production for ADHD Medications. Company Website.
- Cambridge Laboratories. (2021). Supply of Amphetamine Compounds for Pharmaceutical Use. Product Catalog.
- Taj Pharmaceuticals. (2022). API Manufacturing for Global Markets. Corporate Brochure.
- BASF. (2021). Pharmaceutical Polymers for Extended-Release Formulations. Product Literature.
- Jain Irrigation Systems. (2022). GMP-Grade Gelatin and Capsules for Pharmaceuticals. Company Website.
- Colorcon. (2022). Film Coatings and Excipients for Controlled-Release Drugs. Product Catalog.
- Eurofins Scientific. (2022). Quality Assurance Testing for Pharmaceutical Products. Lab Reports.
- McKesson. (2022). Pharmaceutical Distribution Services. Corporate Overview.
- IHS Markit. (2022). Supply Chain Resilience in the Global Pharmaceutical Sector. Industry Analysis.
