Last updated: February 23, 2026
Who are the primary suppliers of Azstarys?
Azstarys (dexmethylphenidate hydrochloride and Serdexmethylphenidate hydrochloride) is an extended-release medication approved for attention deficit hyperactivity disorder (ADHD) in children aged 6 and older. As of 2023, the drug is marketed exclusively by Palo Alto, California-based Corium International.
Manufacturing and Supply Chain Details
Active Pharmaceutical Ingredient (API) Sources
Corium International develops the finished product in-house, sourcing APIs from multiple suppliers primarily based in Asia and the United States:
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Dexmethylphenidate hydrochloride: Sourced from specialty chemical producers in China, India, and the U.S.
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Serdexmethylphenidate hydrochloride: Patent-protected and supplied by Corium or licensed partners; its manufacturing is centralized in the U.S. under Corium's facilities.
Finished Dosage Form Production
Corium handles formulation, tablet manufacturing, packaging, and distribution. They operate manufacturing facilities in the U.S., which meet FDA standards (current Good Manufacturing Practices, cGMP).
Suppliers and Partners
Corium does not publicly disclose all raw material suppliers, but industry sources indicate:
- Multiple Chinese chemical companies provide APIs such as dexmethylphenidate hydrochloride.
- U.S.-based CMOs (Contract Manufacturing Organizations) perform final formulation and packaging.
Regulatory and Supply Chain Integrity
- FDA Compliance: Corium's manufacturing facilities are inspected regularly to ensure compliance.
- Supply Chain Risks: Dependence on API from China poses risks related to geopolitical tensions, COVID-19 disruptions, and regulatory changes.
Market and Competitive Landscape
- Unique Supplier Dependency: Currently, Corium relies primarily on third-party API suppliers for dexmethylphenidate hydrochloride.
- Potential for Supply Chain Diversification: Regulatory agencies increasingly recommend diversification of API sources to mitigate risk.
Industry Context and Trends
- API Sourcing Shifts: China and India dominate global production of methylphenidate APIs.
- Regulatory Scrutiny: U.S. and European authorities push for transparency and supply chain security for critical APIs.
Summary
Corium International controls the production and distribution of Azstarys. The active ingredients's APIs originate mainly from Chinese chemical suppliers, with formulation and final tablet assembly performed in U.S. facilities. Dependency on Asian API sources creates potential vulnerabilities, prompting discussion of supply chain diversification.
Key Takeaways
- Only Corium International markets Azstarys as of 2023.
- The drug's key APIs are primarily sourced from China and India.
- The U.S. facilities oversee formulation, packaging, and quality control.
- Reliance on foreign API manufacturers presents supply chain risks.
- Regulatory environments are increasingly emphasizing supply chain resilience and transparency.
FAQs
Q1: Are there alternative suppliers for Azstarys APIs?
Currently, Corium International sources dexmethylphenidate hydrochloride mainly from Chinese suppliers. While alternative sources exist globally, no public documentation confirms multiple API suppliers for Azstarys's ingredients.
Q2: Is the API sourcing for Azstarys subject to import restrictions?
Potentially. U.S. authorities scrutinize imports from China due to geopolitical and safety concerns. Supply chain disruptions are possible if trade policies change.
Q3: Can other pharmaceutical companies produce generic versions of Azstarys?
Generics require non-infringing patents or licensing agreements. As of 2023, no generic version has been approved, and Corium holds the exclusive rights.
Q4: Have there been supply disruptions related to API sourcing?
No public reports of specific disruptions affecting Azstarys. However, broader API supply chain issues, particularly from China, could impact future availability.
Q5: Are there ongoing efforts to domesticize API production for ADHD medications?
Yes. The U.S. government and pharmaceutical industry explore onshore API manufacturing to improve supply security, but significant scale-up is still in development.
References
- U.S. Food and Drug Administration. (2022). Azstarys prescribing information.
- Corium International. (2023). Corporate report and product overview.
- U.S.-China Trade Commission. (2022). API supply chain assessments.
- International Pharmaceutical Industry Reports. (2022). API sourcing trends.
- FDA. (2022). Supply chain security initiatives.
