ALECTINIB HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and packagers

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 25, 2026

Alectinib Hydrochloride Suppliers: Who Manufactures API, Key Intermediates, and Finished Dosage Forms?

Alectinib hydrochloride supply is concentrated around a small set of global API manufacturers and licensed finished-dose suppliers for Alecensa (alectinib) under Roche’s commercial chain. Market access for new entrants is constrained by (1) API qualification requirements, (2) limited alternates that can demonstrate bioequivalence and impurity control for alectinib hydrochloride, and (3) patent and regulatory exclusivity dynamics that tighten supplier switching windows.

What companies supply alectinib hydrochloride API and finished drug product?

The supply chain for alectinib hydrochloride typically falls into three layers:

API (active pharmaceutical ingredient) manufacturers: produce alectinib API and supply partners for drug product.
Key intermediate and process suppliers: produce advanced intermediates used in the synthetic route.
Finished dose manufacturers: fill, finish, and package the final capsule/tablet dosage form for branded and generic supply.

Alectinib is marketed as Alecensa (alectinib) by Roche/Genentech in the US. Finished-dose supply is handled through Roche’s commercial manufacturing network and contracted partners; API supply is sourced from qualified API producers. Public listings and regulatory-facing documentation generally determine qualification.

Net effect for sourcing: unless a supplier is already listed on the relevant Drug Master File (DMF) or has FDA and/or reference product qualification history, they face long qualification lead times before winning supply positions.

How do you identify legitimate alectinib hydrochloride suppliers (API qualification and regulatory pathways)?

Alectinib hydrochloride suppliers are typically screened through:

FDA DMF status (API and/or manufacturing process DMFs used by ANDA/505(b)(2) filers)
Orange Book ties for the finished product (which indicates the innovator and related listed patents, not supplier identities directly)
Batch release and impurity profiles consistent with pharmacopeial and internal specifications
Site compliance history (FDA inspections and foreign regulatory outcomes)

Practical sourcing signal for procurement teams: the most reliable “who supplies” answers come from the ANDA/505(b)(2) technical packages (where DMF references and API procurement are disclosed) and from regulatory filings that name manufacturing sites.

Which regions have the strongest alectinib hydrochloride manufacturing capacity?

Alectinib API manufacturing capacity is primarily concentrated in:

China (large base of oncology API synthesis capacity, extensive generic and CDMO ecosystem)
India (API manufacturing and CDMO capability for advanced oncology compounds)
Europe and the US (primarily finished-dose and some specialized process capacity, with fewer direct API suppliers than China/India)

Implication for buyers: procurement risk is more operational than geographic. The limiting factor is proving consistent impurity control and demonstrating comparable performance to existing qualified supply.

What API suppliers exist for alectinib hydrochloride in the US/Europe market?

The buyer-relevant list of suppliers depends on whether the procurement target is:

Reference product supply (Alecensa branded supply chain)
Generic/market-entry supply (ANDAs/505(b)(2) that cite alectinib API sources via DMFs)
Contract manufacturing / custom synthesis (CMO/CDMO build-to-spec)

Without specific, extractable regulatory or filing citations, no defensible supplier list can be provided at the company-name level. This topic is filing-driven: supplier identities are tied to DMFs and manufacturing site disclosures that are not consistently published in public product pages.

What suppliers typically handle alectinib hydrochloride intermediates and process steps?

Alectinib’s synthesis involves multi-step chemistry typical of advanced kinase inhibitor scaffolds. Intermediate suppliers usually provide:

Advanced protected intermediates
N-heterocycle or amide-forming intermediates
Salt-forming capability for conversion to hydrochloride

For sourcing, intermediates matter because they:

determine impurity spectrum in the final API
drive process robustness for scale-up
affect batch-to-batch consistency required for regulatory filings

How do CDMOs and custom synthesis providers fit into alectinib hydrochloride supply?

Where a buyer cannot source directly from an API manufacturer:

CDMOs provide API manufacturing under commercial GMP
Some CDMOs offer process development + cGMP under a regulatory bridge plan
Others provide clinical API only, which often does not translate directly to full commercial scale

Alectinib hydrochloride projects are usually not “commodity CDMO” work. They demand established impurity control strategy, analytical package readiness (HPLC/LC-MS methods), and regulatory documentation quality.

What are the biggest sourcing risks for alectinib hydrochloride?

Key constraints observed in advanced oncology API markets:

Analytical method transfer delays (especially for impurity profiling)
Batch rejection risk due to impurity drift
Regulatory timeline effects (qualification and inspection schedules)
Capacity scheduling tied to other oncology lines

Procurement teams typically mitigate this by dual-sourcing and locking long lead-time contracts after qualification.

Key Takeaways

Alectinib hydrochloride supply is dominated by qualified API manufacturers and their licensed/contracted routes into finished-dose production.
Supplier identification for procurement is typically determined by DMF references and manufacturing site disclosures in FDA submissions rather than by generic product pages.
Sourcing risk is driven by impurity control, method transfer, and qualification timelines, not by geography alone.

FAQs

How can procurement teams confirm an alectinib hydrochloride API supplier is FDA-qualified?
By verifying DMF references and matching manufacturing site disclosures in regulatory filings for marketed or pending dosage forms.
Do alectinib hydrochloride supplier lists differ for branded versus generic supply?
Yes. Brand supply runs through Roche’s qualified network, while generics depend on DMF-linked API suppliers used in ANDAs/505(b)(2) submissions.
What manufacturing form must suppliers provide for alectinib hydrochloride? API or finished drug product?
API suppliers typically provide alectinib hydrochloride API in cGMP form for drug product manufacturing, while finished-dose suppliers provide capsules/tablets with packaging readiness.
What qualification steps block new alectinib hydrochloride suppliers from entering the market?
Analytical comparability, impurity profile matching, process validation, and regulatory file acceptance.
What is the most time-sensitive step when qualifying a new alectinib hydrochloride supplier?
Impurity and method transfer with batch release alignment, usually followed by site and documentation readiness for regulatory review.

References

(No sources were cited because no publicly verifiable supplier-name dataset was provided in the prompt.)

Suppliers and packagers for generic pharmaceutical drug: ALECTINIB HYDROCHLORIDE