Suppliers and packagers for AKEEGA

AKEEGA

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	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793	NDA	Janssen Biotech, Inc.	57894-050-60	1 BOTTLE in 1 CARTON (57894-050-60) / 60 TABLET, FILM COATED in 1 BOTTLE	2023-08-11
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793	NDA	Janssen Biotech, Inc.	57894-100-60	1 BOTTLE in 1 CARTON (57894-100-60) / 60 TABLET, FILM COATED in 1 BOTTLE	2023-08-11

AKEEGA suppliers: Who makes the API, tablets, and packaging for AKEEGA (niraparib/abiraterone) and what supply-chain risks matter

Last updated: May 29, 2026

AKEEGA supply is constrained by how Janssen sells and distributes the branded therapy in the US and by manufacturer coverage for each commercial presentation. Public-facing supplier detail (API vs. finished dose vs. packaging) typically appears through FDA drug listings, the Orange Book manufacturing descriptions, and contract-manufacturing footprints on approved-label labeling. The supplier map below reflects the supplier structure used for FDA-regulated drug products and identifies the parties that most often sit in the value chain.

What manufacturers supply AKEEGA (abiraterone acetate + niraparib) tablets in the US?

Direct-answer: AKEEGA’s US supply is controlled by Janssen’s branded commercialization, with drug substance and finished-dose manufacturing typically assigned to registered FDA manufacturers listed on the product’s FDA submission record and Orange Book “manufactured for” and “dosage form” manufacturing descriptions.

Finished-dose (tablets) and packaging: what “supplier” usually means for AKEEGA

For regulated oral solid drugs, “supplier” in investor and procurement workflows usually splits into:

• Drug product manufacturer (site that makes the finished tablets, including blending, compression, coating, and packaging readiness)
• Packaging site(s) (bottling/blister packaging sites if different from bulk manufacturing)
• Labeling/secondary packaging (cartoning and compliance labeling)
• Quality/regulatory contacts (often the same entity, sometimes different affiliates)

How to identify the actual AKEEGA drug product manufacturer quickly

High-intent buyers typically map the supplier from three public anchors:

1. FDA Orange Book manufacturing entries tied to the AKEEGA NDA and strengths
2. FDA Drugs@FDA product details and related labeling PDFs
3. NDC directory and listing that indicates the “listed drug” manufacturer labeler and sometimes the manufacturing/packaging site

Which companies are AKEEGA suppliers on the Orange Book manufacturing entries?

Direct-answer: AKEEGA supplier companies are those named on Orange Book manufacturing descriptions for the NDA and its strengths (listed under the approved dosage forms and package sizes).

What counts as an Orange Book “supplier”

Orange Book “manufactured for” and “manufactured by” fields are frequently the most actionable because they tie to:

• physical dosage form control and batch release
• site-specific cGMP accountability
• licensing and generic design-around considerations (composition and manufacturing steps)

Supplier coverage by dosage strength and package

AKEEGA oral solid products usually have multiple strengths and NDCs. Supplier coverage can differ by:

• tablet strength (if formulations differ)
• packaging configuration (bottle vs. blister)
• market segment (US vs. other jurisdictions)

Who supplies the AKEEGA drug substance (API) and who makes the finished tablets?

Direct-answer: AKEEGA’s drug substance (API) and finished-dose suppliers are the separate parties named in FDA filings or disclosures that track the NDA’s manufacturing sites. API suppliers may differ by route, polymorph control strategy, and scale-up history.

API supplier structure for combination oncology therapies

For combination regimens like AKEEGA, supply chain risk typically comes from:

• a single API constrained by a specialized intermediate step
• a dedicated coating or press-ready excipient system
• a shared packaging line that must run long label batches

Common ways API suppliers are reflected in regulatory sources

• NDA chemistry-manufacturing controls (CMC) sections list the drug substance manufacturing sites
• Orange Book may show only the finished-dose parties, while API sites appear in NDA manufacturing facilities lists

What supply-chain risks affect AKEEGA availability?

Direct-answer: For branded oral oncology products, availability risk usually clusters around cGMP capacity, batch release constraints, packaging line throughput, and post-approval CMC changes.

Where bottlenecks arise for oral solid drugs

• compression or coating capacity
• cross-site transfer during process validation upgrades
• packaging line scheduling with label security controls
• inspection outcomes affecting batch release

What investors track as leading indicators

• FDA shortage announcements tied to the specific NDCs
• recurring batch rejections or recall events
• CMC supplement timelines that trigger temporary manufacturing pauses

How does Janssen’s distribution model affect “supplier” visibility?

Direct-answer: Janssen is the branded commercialization and distribution entity for AKEEGA in the US; supply-side manufacturing may be outsourced and not visible as “Janssen” on all procurement documents.

Why procurement teams map suppliers from NDC and Orange Book, not labels

The label shows commercial owner and often “manufactured for” language. Procurement sourcing requires:

• site-level cGMP confirmation
• batch-release accountability
• supply continuity across NDCs and strengths

Which AKEEGA generic or biosimilar launches could disrupt the supplier base?

Direct-answer: Generic disruption risk is tied to Orange Book patent and exclusivity status and to whether generic manufacturers can reliably qualify API and tablet manufacturing. Supplier disruption in practice is driven by generic volume absorption, not just legal entry.

Paragraph IV threats and supply implications

When a Paragraph IV challenge is filed, it usually triggers:

• API sourcing re-qualification
• scale-up and process validation competition
• additional inspection exposure if entrants ramp quickly

Product switching risk across combined regimens

If payers or hospitals switch regimens due to availability:

• alternative suppliers become the default
• demand shifts can overload specific manufacturing lines

What is the Orange Book status of AKEEGA and how does that affect supply?

Direct-answer: Orange Book status determines entry timing more than supplier selection. The closer the product is to expiry or exclusivity loss, the more likely you see:

• secondary supply contracts
• qualification of alternative manufacturing sites
• API re-sourcing preparations

Patent estate linkage to manufacturing readiness

Manufacturing readiness for generics is built around:

• combination product formulation constraints
• dissolution and bioequivalence acceptance
• traceability and analytical method transfer

What is the AKEEGA competitive landscape for sourcing and manufacturing?

Direct-answer: Competitive sourcing is driven by the specialized manufacturing capacity to make oral solid oncology tablets and by the supply availability of the specific APIs involved in AKEEGA.

Where competition appears in practice

• alternative API sourcing for the same chemical entity
• contract manufacturing organizations (CMOs) with oncology tablet capacity
• packaging partners able to handle secure-label formats

How procurement teams evaluate supplier competitiveness

• inspection history (Form 483 frequency and classification)
• batch failure rate
• capacity utilization and lead times
• ability to transfer manufacturing between sites without product discontinuity

Key takeaways

1. AKEEGA “suppliers” in procurement terms should be mapped from FDA Orange Book manufacturing descriptions and NDC-linked manufacturer/packager entries, not from the commercial label alone.
2. Expect separate parties for drug product manufacturing and packaging, with additional party separation for drug substance/API depending on the NDA’s CMC commitments.
3. The highest supply risks for branded oral oncology products are manufacturing cGMP capacity, batch release constraints, and packaging line throughput.
4. Generic entry risk increases only when legal barriers (Orange Book patents/exclusivity) loosen enough to justify process qualification and ramp-up, which can then stress incumbent supplier networks and change sourcing demand.

FAQs

1) Where can I find the AKEEGA manufacturer name for each NDC strength?

Check FDA Orange Book manufacturing entries for the AKEEGA NDA and cross-reference the NDC directory’s listed labeler/manufacturer entries for each strength and package size.

2) Does AKEEGA use the same manufacturer for all strengths?

Not always. Strength-specific formulation work or line allocation can lead to different finished-dose manufacturing sites or packaging partners per NDC.

3) How do API suppliers show up for AKEEGA if Orange Book focuses on drug product?

API manufacturing sites are typically described in the NDA CMC section and manufacturing facilities disclosures tied to the approved application rather than in Orange Book “manufactured by” fields.

4) What supplier changes are most likely to trigger availability issues for AKEEGA?

Site transfers for tablet manufacturing, coating/compression line changes, packaging line swaps, and CMC supplements that pause batch release pending validation.

5) How do Paragraph IV filings change AKEEGA supply planning?

They drive entrants to qualify alternative API and tablet manufacturing capacity, which can pull capacity from incumbent suppliers and increase batch release competition as launch approaches.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (AKEEGA NDA record). US Food and Drug Administration.
2. FDA. Drugs@FDA: AKEEGA (niraparib/abiraterone) (label, approval history, and manufacturer listing details). US Food and Drug Administration.
3. FDA. NDC Directory. US Food and Drug Administration.