Suppliers and packagers for Alecensa

Alecensa

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434	NDA	Genentech, Inc.	50242-130-01	1 BOTTLE, PLASTIC in 1 CARTON (50242-130-01) / 240 CAPSULE in 1 BOTTLE, PLASTIC	2015-12-11
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434	NDA	Genentech, Inc.	50242-130-86	1 BOTTLE, PLASTIC in 1 CARTON (50242-130-86) / 240 CAPSULE in 1 BOTTLE, PLASTIC	2015-12-11

Suppliers and packagers for Alecensa

Last updated: May 25, 2026

Alecensa (alectinib) Suppliers: What companies manufacture and supply the drug, API, and key intermediates?

Executive summary: Alecensa (alectinib) supply is dominated by the branded product supply chain (Roche/Genentech and contract manufacturers) plus upstream API and intermediate providers tied to aetiologically similar small-molecule kinase inhibitors. Public-facing supplier visibility varies by jurisdiction and dosage form, with the most reliable data typically coming from FDA inspections, published DMFs, Orange Book manufacturing sites, and procurement documents tied to API/intermediate registrations.

Who are the main suppliers for Alecensa (alectinib) in the US and globally?

Featured snippet answer: The branded supply chain is controlled by Roche/Genentech as marketing authorization holder and by contract manufacturers for finished dosage forms. Upstream, the alectinib API supply is sourced through API manufacturers listed in Drug Master Files (DMFs) and through intermediate suppliers used in the API route.

Finished dosage form supply (tablets/capsules)

Finished-dose “supplier” roles typically split into:

• Marketing authorization holder / branded manufacturer: Roche/Genentech
• Contract manufacturing organizations (CMOs): fill-finish and tablet manufacturing sites vary by lot, geography, and FDA inspection history
• Label/packaging supply: packaging suppliers are often site-specific and not consistently disclosed publicly

Alecensa API supply (alectinib)

Upstream supply depends on:

• DMF holders for alectinib API (and sometimes specific intermediates)
• Inspection history for compliance (site-level supply continuity)
• Change-control history (process validation transfers and site transfers)

Because the term “supplier” is used differently across procurement (finished product vs API vs intermediates), supplier lists must be anchored to an evidence source: Orange Book/manufacturer listings, DMF-linked manufacturers, or official FDA inspection outcomes.

What companies manufacture Alecensa tablets and who fills the supply chain?

Featured snippet answer: Alecensa’s US supply is produced under Roche/Genentech oversight with CMO-made finished product. The “who manufactures” question is answered most consistently via:

• FDA Orange Book “Manufacturer” listings for each NDC/strength
• FDA inspection observations and establishment identifiers tied to the finished drug product

How to map finished-product suppliers to establishment IDs

For actionable supplier selection, map:

1. NDC and strength → Orange Book listing manufacturer(s)
2. Manufacturer name → FDA establishment ID(s)
3. Establishment ID → FDA inspections and import alerts (if any)

Which companies supply alecensa active pharmaceutical ingredient (alectinib) API?

Featured snippet answer: Alecensa API suppliers are the DMF holders and the API manufacturing sites tied to those DMFs. The most defensible supplier identification comes from DMF linkages and site-level FDA data, not from generic marketing claims.

Common supplier risk points in small-molecule kinase inhibitor API

Procurement and IP risk for alectinib API often hinges on:

• Single-site dependencies for a constrained synthesis route
• Intermediate qualification status (if an intermediate supplier changes, requalification can bottleneck supply)
• Regulatory filing coupling (site transfers require updated CMC support)

What intermediates are used to make alectinib, and who supplies them?

Featured snippet answer: Alecensa’s upstream “intermediate suppliers” are typically specialized chemical manufacturers supplying key synthetic building blocks used in the alectinib route. Intermediate supply is usually contracted and less transparently listed than finished product.

Intermediate supplier categories

• Heteroaromatic building block suppliers
• Boron/halogenated intermediate suppliers (route-dependent)
• Chiral or late-stage functionalization suppliers (route-dependent)

How does Orange Book listing identify Alecensa manufacturing suppliers?

Featured snippet answer: The Orange Book lists the drug product manufacturer(s) for each NDA/NDC strength. It does not comprehensively list all API or intermediate suppliers, but it is the highest-signal public proxy for finished-dose sourcing.

What Orange Book can and cannot tell

• Tells you: finished dosage form manufacturer for each listed product
• Doesn’t reliably tell you: which site makes the API, which intermediate supplier is used, or which supplier makes every lot

What is the FDA manufacturing and compliance profile for Alecensa suppliers?

Featured snippet answer: Compliance-driven supply continuity is tied to FDA inspection outcomes for the establishments manufacturing the finished product and the API sites linked via DMF and CMC submissions.

Inspection signals procurement teams use

• Establishment inspection classifications (official outcomes)
• Recurring observation themes (sterility and microbiology are less relevant for tablets, but aseptic is not typically part of oral kinase inhibitor production)
• Batch record integrity and data governance findings that impact release timelines

Are there multiple Alecensa suppliers by geography (US vs EU vs Japan)?

Featured snippet answer: Yes. Finished-dose manufacturing and logistics typically vary by market. EU/UK/Japan sourcing can include different CMOs and importers, even if the marketing authorization holder is the same.

Where geography changes supply

• Importation controls and local regulatory submissions
• Cold chain is usually not required for oral solid alectinib, so logistics constraints are mainly warehousing and distribution
• Local language labeling and packaging lead times

Which companies are suppliers for Alecensa through CDMO relationships?

Featured snippet answer: The supplier pool for finished dose is mainly CMOs working under Roche/Genentech’s quality system. CDMO identities are typically not stable public lists unless cross-referenced through:

• Orange Book product manufacturer names
• FDA establishment inspection records
• Import registration and site listings tied to NDA supply chain

What generic entry risks exist for Alecensa supplier availability?

Featured snippet answer: Generic and biosimilar risk for alectinib itself is mostly a small-molecule generic risk (not biosimilar). Supplier pressure rises when:

• There is a shift from single-source branded supply to multiple sources post-exclusivity
• API supply tightens due to contract or intermediate qualification constraints
• Litigation delays formulation or CMC transfers

Why supplier risk rises during exclusivity transitions

Even if regulatory approval is ready, manufacturing readiness is not guaranteed. API site readiness and intermediate qualification can become the real bottleneck.

How do manufacturing and IP constraints affect supplier options for alectinib?

Featured snippet answer: IP constraints affect which manufacturers can produce viable commercial alectinib safely and lawfully, especially for API/process inventions and formulation methods.

Practical constraints for new entrants

• Process patent coverage can restrict alternative synthetic routes
• Control of key intermediates can delay substitution of suppliers
• Regulatory filing ownership can limit cross-referencing and reduce speed-to-market

What does Alecensa’s supply chain look like end-to-end (API to finished product)?

Featured snippet answer: An end-to-end model is:

1. Alecensa API produced at one or more DMF-listed sites
2. Finished-dose conversion into tablets by a finished-dose manufacturer/CMO
3. Packaging and labeling by secondary facilities
4. Release testing and distribution under Roche/Genentech’s quality oversight

Supplier mapping checklist used for procurement

• Validate finished-dose manufacturer via Orange Book for the exact NDC/strength
• Validate API site via DMF linkage and CMC references
• Validate intermediate availability through qualification records tied to the API route
• Check for recent regulatory compliance events at each site

Key Takeaways

• Finished-dose “supplier” visibility is best anchored to Orange Book drug product manufacturer listings by NDC strength.
• API “supplier” visibility is best anchored to DMF-linked manufacturers and corresponding FDA inspection establishment records.
• Alecensa supply continuity depends less on public procurement listings and more on site qualification, DMF linkage, and inspection outcomes across both API and finished-dose facilities.
• Supplier diversification varies by geography, and procurement risk often tracks single-site API or intermediate dependencies and qualification timelines.

FAQs

1. How do I identify Alecensa (alectinib) tablet manufacturers by NDC strength in the US?
2. Which FDA filings indicate the alectinib API manufacturing sites for Alecensa?
3. Can I source alectinib API from alternative intermediate suppliers without requalification risk?
4. What inspection outcomes most commonly disrupt tablet drug supply for oral kinase inhibitors?
5. How does exclusivity and generic entry timing affect alectinib supplier availability?

References

1. U.S. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Orange Book database).
2. U.S. FDA. Drug Master Files (DMF) program information and public resources.
3. U.S. FDA. Establishment Registration and Device Listing / Drug facility inspection program information.