Suppliers and packagers for apokyn

apokyn

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mdd Us	APOKYN	apomorphine hydrochloride	INJECTABLE;SUBCUTANEOUS	021264	NDA	MDD US Operations, LLC	27505-004-05	5 CARTRIDGE in 1 CARTON (27505-004-05) / 3 mL in 1 CARTRIDGE (27505-004-01)	2004-07-02

Suppliers and packagers for apokyn

Last updated: May 30, 2026

APOKYN (apomorphine hydrochloride) Suppliers: Who Manufactures the Drug Substance and Finished Product?

APOKYN (apomorphine hydrochloride) is marketed in the US by Sunovion Pharmaceuticals. The key commercial supply chain in practice is controlled by the drug product manufacturer(s) listed on US FDA labeling and by contract manufacturers used for sterile manufacturing, fill-finish, and packaging.

No complete, source-backed supplier roster (drug substance + sterile fill-finish + labeler/packager across all markets) can be produced from the information available here.

Who supplies APOKYN (apomorphine) to the US market through FDA labeling?

Featured answer: Use the “Manufactured for” and “Distributed by” statements on the most recent APOKYN US prescribing information to identify the finished product manufacturer and label/distributor for that version of the product.

What to extract from APOKYN US prescribing information

APOKYN labeling typically discloses:

• Finished product manufacturer name and address (“Manufactured for …”)
• Distributor/labeler (“Distributed by …”)
• Packaging form (for example, cartridge system and dosing configuration, where applicable)

Why labeling is the first-stop supplier dataset

For US commercial supply, FDA labeling is the most directly auditable public artifact connecting:

• the accountable legal entity in marketing,
• the actual manufacturer of record for that product version,
• and the US distribution chain.

Which companies manufacture the sterile apomorphine injection and fill-finish APOKYN?

Featured answer: The sterile fill-finish and packaging supplier is identified by the manufacturer of record in labeling and by any disclosed manufacturer addresses.

Common sterile manufacturing roles relevant to APOKYN

When mapping APOKYN supply risk and manufacturing capacity, the supply chain usually splits into:

• Sterile drug product manufacturing (aseptic processing)
• Sterile fill-finish (cartridge filling, sealing, visual inspection, packaging)
• Secondary packaging and distribution

What drives switching between suppliers

Switching finished product suppliers generally occurs via:

• FDA comparability data packages and CMC updates
• inspection outcomes
• contractual capacity constraints
• packaging component availability

Do drug substance suppliers exist separately for apomorphine hydrochloride used in APOKYN?

Featured answer: Drug substance suppliers are not usually named in consumer-facing labeling; they surface in supplier databases, DMFs, regulatory filings, or investigative procurement documentation.

How drug substance vendors typically surface in pharma workstreams

• Drug Master Files (DMFs) tied to apomorphine hydrochloride synthesis routes
• Custom synthesis and purification at scale
• Supply agreements feeding sterile finished product manufacturers

What is the Orange Book status of APOKYN, and does it list manufacturers/suppliers?

Featured answer: The Orange Book primarily lists FDA-approved application(s) and patents/exclusivity, not a full supply chain roster.

How Orange Book data helps supplier mapping

For APOKYN, Orange Book entries can support:

• identifying the approved application(s)
• linking to reference product/ANDA relationships if a generic exists
• scoping whether supply chain concerns are tied to formulation/patent status rather than manufacture

Are there generic or biosimilar APOKYN suppliers, and can they change supply?

Featured answer: If an FDA-approved generic exists, its labeler and manufacturer of record would be visible in the generic prescribing information, and supply changes can occur when wholesalers shift procurement.

How to evaluate “supplier availability” risk

Supplier availability is driven by:

• number of approved manufacturing sites
• whether multiple labelers source from the same sterile facility
• contractual exclusivity and launch timing under market access agreements

What contract manufacturing barriers affect APOKYN supply continuity?

Featured answer: Aseptic/sterile capability, validated processes for injection systems, and regulatory inspection history typically represent the binding constraints.

Key barriers

• Sterile aseptic processing capacity for apomorphine injection
• Environmental monitoring and aseptic controls for small-volume injectables
• Cartridge/system compatibility and stability qualification
• Supply continuity for critical components and packaging

Key Takeaways

• APOKYN supplier identification for US market procurement is anchored in the “Manufactured for” and distributor statements in the US prescribing information for the latest product version.
• A full “drug substance + sterile fill-finish + packaging” supplier roster cannot be listed here without sourcing from FDA labeling, Orange Book-linked application details, and/or regulatory submissions.
• Sterile manufacturing capability is the primary operational bottleneck that constrains supplier substitution and supply continuity.

FAQs

1. Where exactly on the APOKYN label do I find the finished product manufacturer?
   Check the “Manufactured for” section in the APOKYN prescribing information.

2. Does the Orange Book list APOKYN manufacturing sites?
   The Orange Book is structured around approvals and patents/exclusivity, not a complete list of manufacturing sites.

3. Can APOKYN supply be affected by cartridge/system component shortages?
   Yes, injectable device/components and qualified packaging supply can create discontinuities even when API is available.

4. How do I identify drug substance suppliers for apomorphine used in APOKYN?
   Drug substance suppliers usually appear via DMF-linked documentation, regulatory submissions, or specialized supplier databases.

5. What data best supports supplier-change assessments for procurement?
   FDA labeling manufacturer-of-record statements paired with CMC/CMC-change histories and inspection outcomes for the sterile facility.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US FDA. (Accessed via FDA Orange Book portal).
2. US Prescribing Information for APOKYN (apomorphine hydrochloride). Sunovion Pharmaceuticals. (Latest US labeling version).