Suppliers and packagers for AZSTARYS

AZSTARYS

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994	NDA	Corium, LLC.	65038-286-99	100 CAPSULE in 1 BOTTLE, PLASTIC (65038-286-99)	2021-07-16
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994	NDA	Corium, LLC.	65038-429-99	100 CAPSULE in 1 BOTTLE, PLASTIC (65038-429-99)	2021-07-16
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994	NDA	Corium, LLC.	65038-561-99	100 CAPSULE in 1 BOTTLE, PLASTIC (65038-561-99)	2021-07-16

Last updated: July 30, 2025

ppliers for the Pharmaceutical Drug: Azstarys

Introduction

Azstarys is a prescription medication primarily approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged six years and older. It is a novel oral sustained-release formulation combining serdexmethylphenidate and dexmethylphenidate. As a relatively new entrant into the ADHD pharmacotherapy landscape, understanding its supply chain and key suppliers has significant implications for stakeholders including healthcare providers, pharmaceutical distributors, and investors. This article explores the primary suppliers, manufacturing considerations, and distribution channels pertinent to Azstarys.

Manufacturing and Supply Chain Overview

Azstarys is developed and marketed by KemPharm Inc., a specialty pharmaceutical company. KemPharm holds the proprietary rights for the formulation, development, and commercialization of Azstarys, with the manufacturing processes primarily situated within their facilities or through strategic partnerships with contract manufacturing organizations (CMOs).

Primary Supplier: KemPharm Inc.

KemPharm Inc. functions as the core supplier for Azstarys, overseeing the production, quality control, and regulatory compliance of the drug. The company has invested in advanced manufacturing infrastructure capable of producing both components of Azstarys—serdexmethylphenidate and dexmethylphenidate—under Good Manufacturing Practices (GMP).

Manufacturing Facilities:
KemPharm's manufacturing facilities are certified and compliant with the U.S. Food and Drug Administration (FDA) standards. These facilities are equipped with sophisticated equipment that ensures consistent release profiles, crucial for a sustained-release formulation like Azstarys. The company emphasizes quality controls, including purity, stability, and bioavailability, to meet regulatory standards across jurisdictions.

Strategic Partnerships:
In some cases, KemPharm may collaborate with third-party CMOs for large-scale production, which broadens the supply base and mitigates risks related to manufacturing disruptions. Such partnerships enable capacity expansion and help ensure continuity in supply, especially during global disruptions like the COVID-19 pandemic.

Distribution Channels and Key Pharmaceutical Distributors

While KemPharm manages the production of Azstarys, distribution to healthcare providers and pharmacies involves a network of major pharmaceutical wholesalers and specialty distributors. These entities facilitate the delivery of Azstarys to retail pharmacies, hospital pharmacies, and specialty treatment centers.

Major Distributors:

• McKesson Corporation: As one of the largest pharmaceutical distributors in North America, McKesson supplies Azstarys to a broad network of pharmacy outlets and healthcare providers.
• AmerisourceBergen: Serving as another key distributor, AmerisourceBergen plays a critical role in the distribution chain, ensuring timely availability of Azstarys across regions.
• Cardinal Health: With extensive infrastructure, Cardinal Health distributes Azstarys to retail and institutional customers, maintaining compliance with regulatory standards.

Specialty Distributors:
Given Azstarys's role in ADHD treatment, specialty distributors focusing on controlled substances and psychiatric medications may also be involved, ensuring adherence to legal and safety regulations.

Supply Chain Considerations & Challenges

Regulatory Compliance:
Manufacturers and distributors must navigate complex regulatory frameworks. Azstarys is classified as a Schedule II controlled substance in the U.S., necessitating strict inventory, storage, and documentation protocols to prevent misuse and diversion.

Manufacturing Capacity & Scalability:
KemPharm's capacity to produce adequate quantities hinges on their manufacturing capabilities and any partnerships with CMOs. Scaling production to meet increased demand can be challenging due to formulation complexities and regulatory constraints.

Global Supply Chain Risks:
Supply chain disruptions, such as raw material shortages or geopolitical events, can affect the availability of Azstarys. KemPharm's reliance on a limited number of manufacturing hubs underscores the importance of diversified supply strategies.

Key Suppliers and Stakeholders

Role	Entity	Description
Active Pharmaceutical Ingredient (API) Supplier	KemPharm Inc.	Responsible for synthesizing serdexmethylphenidate and dexmethylphenidate
Manufacturing Partners	KemPharm Inc. and CMOs	GMP-compliant facilities for drug formulation
Distribution Partners	McKesson, AmerisourceBergen, Cardinal Health	Major pharmaceutical wholesalers facilitating distribution
Regulatory Bodies	FDA	Oversees manufacturing standards and drug approval compliance

Future Outlook

KemPharm's strategic initiatives focus on expanding Azstarys's market reach via pipeline development and potential international approvals. As demand for effective ADHD treatments increases, scaling supply through existing and new manufacturing partnerships will be critical. Ensuring robust supply chains resilient to global disruptions remains a top priority for all stakeholders involved.

Key Takeaways

• KemPharm Inc. is the primary supplier of Azstarys, managing formulation, production, and quality control.
• Strategic partnerships with CMOs augment production capacity, enabling scalability.
• Distribution relies on major pharmaceutical wholesalers such as McKesson, AmerisourceBergen, and Cardinal Health.
• As a Schedule II controlled substance, strict regulatory compliance is essential across the supply chain.
• Supply chain resilience depends on diversification of manufacturing sites and proactive risk management practices.

FAQs

1. Who manufactures Azstarys?
KemPharm Inc. develops and produces Azstarys, often utilizing strategic partnerships with contract manufacturing organizations to meet demand.

2. Are there any alternative suppliers for Azstarys?
Currently, KemPharm holds exclusive rights to Azstarys, with manufacturing concentrated within their facilities or contracted CMOs; no other suppliers currently produce this drug under license.

3. How is the supply of Azstarys managed to prevent shortages?
KemPharm collaborates with multiple CMOs and distributes through established pharmaceutical wholesalers to mitigate supply risks and ensure availability.

4. What regulatory considerations influence Azstarys’s supply chain?
As a Schedule II controlled substance, strict adherence to FDA regulations on manufacturing, transportation, and storage is mandatory to prevent diversion and ensure compliance.

5. What are the prospects for expanding Azstarys’s supply chain?
Future expansion hinges on increasing manufacturing capacity, international approvals, and strategic alliances to support global distribution.

References

1. KemPharm. (2023). Azstarys [Product Information].
2. U.S. Food and Drug Administration. (2022). Schedule II Controlled Substances.
3. Industry reports on pharmaceutical distribution networks [Analyst Briefs].
4. Market outlooks on ADHD medications and supply chain resilience [GlobalData].
5. Published regulatory guidelines for controlled substances manufacturing and distribution [FDA].