DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE: Pharmaceutical manufacturers, suppliers, and wholesalers

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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	Commave Sub, 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	Commave Sub, 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	Commave Sub, LLC	65038-561-99	100 CAPSULE in 1 BOTTLE, PLASTIC (65038-561-99)	2021-07-16
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 26, 2026

Dexmethylphenidate hydrochloride and serdexmethylphenidate chloride are supplied through tightly controlled contract manufacturing networks that include (1) active pharmaceutical ingredient (API) manufacturers and (2) finished-dose and delivery-system manufacturers with FDA-regulated quality systems. The practical supplier list for the U.S. market is best mapped through FDA submissions, Orange Book product listings, and inspection-linked manufacturer identities tied to listed NDA/ANDA products.

Which companies supply dexmethylphenidate hydrochloride API and finished drug?

Short answer: The U.S. supply chain for dexmethylphenidate hydrochloride is dominated by firms that support authorized label holders and their contract manufacturers for capsule/tablet manufacture, coating, and packaging, with API sourced from specialized stimulant/API production networks.

What finished-dose products drive supplier identification in the U.S.

Dexmethylphenidate hydrochloride is primarily marketed as immediate-release and extended-release forms (most notably the extended-release “Focalin” brand line historically; and subsequent generic entries where approved). Supplier discovery in practice uses:

Orange Book label application holders for each marketed strength and dosage form.
FDA Drug Product Manufacturing Information (CDER) and site-level inspection disclosures tied to those labeled products.
ANDA approvals and manufacturing sites listed in ANDA chemistry, manufacturing, and controls (CMC) sections.

Where supplier lists usually consolidate (contract manufacturing map)

For dexmethylphenidate hydrochloride finished products, supplier roles typically include:

Tablet/capsule manufacturing (blend, granulation where applicable, compression/filling).
Film coating and controlled-release finishing steps (for extended-release products).
Packaging (bottling and child-resistant packaging operations).

Because the same sponsor can change contract manufacturers across lifecycle stages, the most decision-grade view is the “current” manufacturing sites per strength and dosage form as reflected by the latest FDA manufacturing site disclosures tied to each approved application.

Which companies supply serdexmethylphenidate chloride API and finished drug?

Short answer: Serdexmethylphenidate chloride (a prodrug of dexmethylphenidate delivered via an extended-release mechanism) is supplied through a smaller set of specialized stimulant prodrug manufacturing networks, with fewer global sources than dexmethylphenidate hydrochloride.

What finished-dose products anchor serdexmethylphenidate supplier mapping

Serdexmethylphenidate chloride products are identified by their NDA holder and the currently listed manufacturing sites for:

Drug substance (API/prodrug) synthesis
Drug product manufacturing (granulation, coating, encapsulation, controlled-release finishing)
Packaging and distribution

The “supplier list” is therefore application-specific and strength/dosage-form specific.

How do API suppliers and finished-dose CMOs split for these stimulants?

Short answer: API is generally supplied by chemical synthesis and crystallization specialists. Drug product is then manufactured by one or more CMOs with controlled-release competence and packaging scale-up capability.

Common role separation

API manufacturers: chemical synthesis, salt formation (for hydrochloride or chloride salt forms), purification, polymorph control, and impurity profiling.
Drug product CMOs: formulation assembly, granulation/coating, in-process controls, dissolution testing, stability program execution, and packaging.

Why the distinction matters for availability

In stimulant supply disruptions, API upstream constraints (reactor capacity, catalyst availability, solvent supply, restricted chemical sourcing) can freeze multiple downstream finished-dose SKUs even where packaging capacity exists.

What FDA/regulatory data reveals the actual manufacturer-supplier identity?

Short answer: For each marketed product, the most reliable supplier identities come from FDA systems that reflect application-specific manufacturing site listings rather than marketing names.

Orange Book and NDA/ANDA manufacturing site linkages

For U.S. access and supplier verification, the core workflow is:

Identify the NDA/ANDA application tied to the product (by label name, strength, and dosage form).
Pull the associated manufacturing site(s) for drug substance and drug product.
Map the site owners (company) to the facility operator.

Inspection-linked risk signals

When planning supply or licensing, the decision-grade supplier view also factors:

Recent FDA inspection outcomes for those sites
Data integrity findings and remediation histories
Recalls linked to manufacturing deviations or stability failures

What patents protect dexmethylphenidate hydrochloride and serdexmethylphenidate chloride supply chain?

Short answer: Patent estates typically protect controlled-release formulations, manufacturing processes, specific salt/prodrug forms, and method-of-use indications. These protections can restrict generic prodrug/formulation variants and can also restrict contract formulation choices for second-source manufacturers.

How supplier selection intersects with patent strategy

Supplier qualification is constrained by:

Freedom-to-operate (FTO) for formulation and manufacturing methods
Whether the CMO is willing to support a branded-to-generic technology transfer
Whether the CMO’s process is “substantially similar” to patented steps

Key patent categories that drive constraints

Drug substance synthesis and salt/prodrug formation
Controlled-release dosage form construction
Method of use for ADHD and related labeling claims
Particle engineering and dissolution-rate control for extended-release behavior

When does exclusivity expire, and when can new suppliers enter?

Short answer: Entry timing is driven by (1) patent expiration and (2) exclusivity periods linked to the approved application (including pediatric exclusivity where applicable) plus the approval timeline of follow-on ANDAs.

How this affects supplier availability

Even where manufacturing capacity exists, new suppliers cannot ship approved product unless:

Their filing is approved under the relevant legal pathways, and
Their formulation/process falls within permitted design-arounds, and
They secure supply agreements for compliant drug product release and distribution.

What generic entry risks exist for dexmethylphenidate hydrochloride supply?

Short answer: Generic entry risks are primarily tied to formulation/process comparability, dissolution profiles for extended-release versions, and the availability of qualified manufacturing sites. The second-order risk is reliance on a small number of API sources.

Supply-chain bottlenecks that delay launches

Limited upstream API capacity
Salt form and impurity specification sensitivity
Controlled-release formulation scale-up failures
Delayed stability or dissolution bridging batches

What generic entry risks exist for serdexmethylphenidate chloride supply?

Short answer: Serdexmethylphenidate’s prodrug-driven release behavior concentrates risk around prodrug synthesis purity, conversion efficiency to active metabolite, and controlled-release product performance.

Entry constraints

Prodrug synthesis and impurity control is typically more complex than simple salt forms
Dissolution and in vivo-to-in vitro correlation must match approved release behavior
CMO willingness to transfer specialized know-how can be a rate-limiting step

How does the competitive landscape compare between dexmethylphenidate hydrochloride and serdexmethylphenidate chloride?

Short answer: Dexmethylphenidate has a broader manufacturing ecosystem because it is the direct active ingredient across more dosage forms and earlier market history. Serdexmethylphenidate is more concentrated due to prodrug complexity, a narrower set of qualified synthesis and formulation networks, and tighter lifecycle constraints.

Supplier implications

Dexmethylphenidate: easier to find qualified alternatives by capacity and dosage-form type, but API-spec and controlled-release performance still gate approvals.
Serdexmethylphenidate: fewer qualified partners, greater emphasis on prodrug CMO depth, and higher risk from upstream synthesis constraints.

Supplier short-listing framework for procurement and licensing

Short answer: Build the supplier list by product-specific FDA manufacturing site validation, then layer procurement risk scoring on API capacity, CMO release track record, and IP design-around feasibility.

Decision-grade checklist

Map manufacturing sites for each approved NDA/ANDA product strength and dosage form.
Validate that the named manufacturer/operator holds quality system readiness for controlled-release and stimulant APIs.
Confirm whether the supplier can support required batch sizes and packaging formats for U.S. distribution.
Screen for site history signals tied to FDA inspections and compliance events.
Assess process “transferability” to your desired legal pathway (ANDAs, authorized generics, or license-in).

Key Takeaways

Dexmethylphenidate hydrochloride supply is typically supported by a wider set of API and CMO resources than serdexmethylphenidate chloride, reflecting earlier market establishment and broader dosage-form coverage.
Serdexmethylphenidate chloride supply is more concentrated due to prodrug synthesis and controlled-release performance requirements.
The most reliable “supplier list” is application-specific: manufacturing sites tied to Orange Book and the corresponding NDA/ANDA must be mapped to facility operators.
Patent estates and exclusivity schedules can constrain who can enter as a supply partner, even if capacity exists.
Supplier qualification for these stimulants must prioritize API impurity specification control, controlled-release dissolution performance, and FDA-inspection-linked quality system maturity.

FAQs

1) What are the main contract manufacturing steps that bottleneck dexmethylphenidate ER supply?
Coating and controlled-release finishing steps, dissolution bridging, and packaging scale-up are the recurring bottlenecks, with API purity and salt formation as upstream constraints.

2) Why is serdexmethylphenidate harder to source than dexmethylphenidate?
Prodrug synthesis impurity control and conversion efficiency requirements raise manufacturing complexity and reduce the number of qualified supply networks.

3) How do I identify the real manufacturer behind a marketed dexmethylphenidate product?
Use the NDA/ANDA label mapping in Orange Book, then tie each strength/dosage form to its FDA-listed manufacturing sites and facility operators.

4) What is the biggest IP risk when switching suppliers for extended-release stimulants?
Controlled-release formulation and manufacturing method claims can restrict acceptable process design-arounds and transferred manufacturing parameters.

5) What supply-chain risk metrics matter most for stimulant procurement?
Upstream API capacity constraints, controlled-release performance history, stability program execution, and site compliance record.

References

FDA. Orange Book: Approved Drug Products with Therapeutapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
FDA. Drugs@FDA. U.S. Food and Drug Administration.
FDA. NDA/ANDA and Drug Product Manufacturing Information resources. U.S. Food and Drug Administration.

Suppliers and packagers for generic pharmaceutical drug: DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE