Suppliers and packagers for generic pharmaceutical drug: APALUTAMIDE

APALUTAMIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951	NDA	Janssen Products, LP	59676-600-12	120 TABLET, FILM COATED in 1 BOTTLE (59676-600-12)	2018-02-14
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951	NDA	Janssen Products, LP	59676-600-56	2 BLISTER PACK in 1 CARTON (59676-600-56) / 28 TABLET, FILM COATED in 1 BLISTER PACK	2018-02-14
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951	NDA	Janssen Products, LP	59676-604-14	1 BLISTER PACK in 1 CARTON (59676-604-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK	2018-02-14
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951	NDA	Janssen Products, LP	59676-604-30	30 TABLET, FILM COATED in 1 BOTTLE (59676-604-30)	2018-02-14

Apalutamide Suppliers: Who Manufactures Apalutamide API, Drug Product, and Key Materials Used by Brand and Generic Makers

Last updated: May 25, 2026

Apalutamide’s supply chain is concentrated among a small set of licensed API manufacturers and contract manufacturing organizations (CMOs) that produce tablets for U.S. and ex-U.S. markets. For licensing, procurement, and litigation risk management, the supplier target map should be split into (1) apalutamide API makers, (2) formulation and tablet CMOs, and (3) packaging and secondary-manufacturing vendors used for finished-dose release.

Which companies supply apalutamide API (active pharmaceutical ingredient)?

Apalutamide API is produced by a limited number of specialty API suppliers. In procurement and regulatory reviews, the authoritative source for “who supplies whom” is the DMF-linked manufacturing site(s) underlying FDA approvals and the drug product site(s) listed on FDA labels and regulatory filings.

What is the typical API sourcing model for apalutamide tablets?

Most apalutamide tablet supply chains use:

• One or more DMF-backed API manufacturing sites for apalutamide substance
• One or more tablet manufacturing sites for finished dosage form
• Shared excipient and packaging vendors (blistering, bottling, cartons)

API suppliers vs. drug-product CMOs: what to separate

For diligence, do not treat “API supplier” and “tablet manufacturer” as interchangeable:

• API supplier defines the chemical manufacturing and DMF/CEP pathway.
• Tablet CMO defines the formulation, blending, compression, coating, and finished-dose release.

Who manufactures apalutamide drug product (tablets) and performs batch release in the US?

Apalutamide tablets are commercialized as Erleada and supplied through brand-linked manufacturing networks for finished dosage forms. Finished-dose manufacturing sites and labeling manufacturing/distribution addresses can be cross-referenced to:

• FDA label “Manufactured for” / “Distributed by”
• NDA/BLA manufacturing site disclosures
• Current Good Manufacturing Practice (cGMP) inspection histories tied to the product label sites

Which dosage form is relevant to supplier mapping?

• Oral tablets (primary commercial dosage form for Erleada)

What Orange Book status determines which apalutamide suppliers matter for generics?

For supplier strategy, Orange Book listings identify covered product configurations and the legal status of apalutamide-related patents. Supplier relevance increases where generic entries depend on:

• Same strength(s) and dosage form
• Same or compatible formulation elements
• Same packaging configuration and labeling requirements

How Orange Book coverage changes supplier risk

If a supplier is tied to a patent-covered formulation, process, or method-of-use landscape, generic launch timing and entry risk shift. Supplier selection should be mapped against:

• Patent estate breadth (compound, polymorph, formulation, and process)
• Whether a generic must design around formulation or process constraints

When do apalutamide exclusivities expire and how does that affect supplier switching?

Exclusivity and patent expiry windows shape supply commitments, because:

• API switching requires qualification and regulatory alignment
• Finished-dose CMO retooling triggers validation, stability, and release process changes

What timelines drive procurement decisions

Supplier switching usually occurs around:

• Patent/market exclusivity milestones that reduce manufacturing lock-in
• Expected generic launch windows
• Pre-qualification timelines needed for contracted batches

What generic entry risks exist for apalutamide and which suppliers are likely targeted?

Generic market entry typically targets:

• API DMFs for apalutamide substance
• Tablet CMO capacity for compression/coating lines
• Packaging capacity for U.S.-compliant labeling systems

Paragraph IV and litigation effects on supply chains

When challengers file Paragraph IV certifications, supplier selection can be constrained by:

• Ability to produce within patent-protected process windows
• Readiness to defend formulation or manufacturing method claims
• Timelines for design-around experiments, if required

How strong is the apalutamide patent estate and how does that change supplier choices?

Patent strength impacts supplier choices in three ways:

1. Design-around feasibility for formulation/process
2. Risk of injunctions tied to specific manufacturing methods or dosage forms
3. Settlement-driven licensing that may lock supply to a narrow set of suppliers

Patent estate categories that influence manufacturing

For apalutamide, diligence typically focuses on:

• Compound claims and polymorph claims (API-level)
• Formulation claims (tablet composition, coating, excipients, dissolution targets)
• Process claims (crystallization, drying, milling, granulation, compression/coating parameters)
• Method-of-use claims (dose regimen and indication coverage)

Which manufacturing jurisdictions are most likely to host apalutamide suppliers?

Apalutamide supply is commonly sourced from:

• India and China API manufacturing ecosystems
• U.S. or EU-based finished-dose manufacturing and release networks for brand supply

What matters for regulatory readiness

Diligence should prioritize:

• FDA inspection outcomes for the relevant site(s)
• Ability to support comparability and validation for dosage form changes
• Stability and packaging compatibility data

What materials besides apalutamide are “supply-critical” for tablets?

Supplier mapping for tablets should include:

• Key tablet excipients used in coating and core formulation
• Granulation and compression aids used for dissolution performance
• Film-coating polymer and pigment systems
• Packaging components (blister or bottle systems), including desiccants and labels

How does apalutamide biosimilar risk differ from generic risk?

Apalutamide is a small-molecule androgen receptor inhibitor, so biosimilar frameworks do not apply the way they do to biologics. The competitive risk is generic and “authorized generic” style competition, not biosimilar substitution.

Commercial supply strategy: what suppliers do companies tend to dual-source?

In practice, dual sourcing for apalutamide is pursued for:

• API substance continuity (avoid DMF site disruptions)
• Finished-dose CMO capacity (prevent batch backlogs)
• Packaging continuity (avoid label/packaging component shortages)

Supplier due diligence checklist for apalutamide (actionable)

• Confirm the apalutamide API manufacturing site(s) tied to the product’s filings (DMF/CEP and cross-references)
• Validate that the tablet CMO performs: blending, granulation (if applicable), compression, coating, and finished-dose QC-release
• Map stability study obligations for any line or site shift
• Assess inspection readiness: cGMP history, data integrity posture, deviation CAPA maturity
• Confirm packaging component compliance and labeling system support

Key Takeaways

• Apalutamide supply chains divide cleanly into API manufacturing sites and tablet drug-product manufacturing/release sites.
• Supplier relevance for market entry and litigation risk depends on whether the supplier is tied to API, specific formulation/process claims, or dosage-form/presentation elements.
• For business decisions, the most actionable supplier map is built from FDA-linked manufacturing sites (for finished drug product) and DMF-linked apalutamide substance sites (for API), then stress-tested against exclusivity and patent expiration timing.

FAQs

1) Which DMF sites support apalutamide API for U.S. market approvals?
DMF-linked apalutamide API manufacturing sites must be pulled from FDA cross-references tied to the approved drug product and labeling manufacturing addresses.

2) Can a tablet CMO switch apalutamide API suppliers without regulatory impact?
Any API site change can require additional comparability, stability support, and regulatory updates, driven by formulation/process sensitivity.

3) What excipients and coating components drive supply constraints for apalutamide tablets?
Film-coating and dissolution-relevant excipients are typically the most supply-critical after the API.

4) What manufacturing steps create the highest patent design-around risk for apalutamide generics?
Crystallization, drying, milling, granulation, and coating/compression parameter windows are the typical process-adjacent pressure points.

5) How does litigation affect apalutamide supplier qualification and contracting?
Litigation can narrow eligible suppliers due to injunction risk, settlement-driven licensing structures, and timing constraints for design-around validation.

References (APA)

No sources were cited because the provided prompt does not include apalutamide-specific supplier identities, FDA label/manufacturing site links, or DMF site identifiers required to produce a complete, accurate supplier list.