Suppliers and packagers for radicava ors

radicava ors

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Kk Bcj-94	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446	NDA	Shionogi Inc.	70510-2321-2	2 CARTON in 1 CARTON (70510-2321-2) / 1 KIT in 1 CARTON (70510-2321-1) * 1 BOTTLE in 1 KIT (70510-2323-1) / 35 mL in 1 BOTTLE	2022-05-12
Kk Bcj-94	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446	NDA	Shionogi Inc.	70510-2322-1	1 KIT in 1 CARTON (70510-2322-1) * 50 mL in 1 BOTTLE (70510-2324-1)	2022-05-12

Suppliers and packagers for radicava ors

Last updated: May 28, 2026

RADICAVA ORS suppliers: who manufactures, supplies, and distributes Radicava oral suspension (edaravone) for ALS?

Executive summary: RADICAVA ORS (edaravone oral suspension) is supplied in the U.S. through Biogen’s RADICAVA product supply chain. Public sourcing is limited: the FDA Orange Book and the NDC package labeling typically identify the listed drug and applicant (not all underlying API and finished-goods manufacturers). For a defensible supplier map, the only supplier-level facts that can be stated from authoritative public listings are the FDA-listed applicant and product labeling manufacturer(s), plus any contract manufacturing sites named in FDA labeling.

What can be stated from public regulatory artifacts: RADICAVA ORS is FDA-approved as edaravone for ALS. The FDA approval and Orange Book record identify the listed drug, while the FDA labeling and product package inserts identify the holder and/or manufacturer for the drug product. The detailed chain for API sourcing (active ingredient suppliers) is typically not fully disclosed in public Orange Book records.

Who supplies RADICAVA ORS (edaravone oral suspension) in the U.S.?

Answer: RADICAVA ORS is supplied under the FDA-listed product and labeling manufacturer/applicant structure for the U.S. market, with Biogen as the commercial/brand applicant in the RADICAVA portfolio.

How FDA listing defines “supplier”

• Applicant/Holder (listed drug record): the entity responsible for the NDA listing and regulatory submissions for the product.
• Drug product manufacturer (labeling/package insert): the site(s) responsible for finished dosage form manufacturing as disclosed in product labeling.
• API supplier: rarely identified in Orange Book listings; sometimes disclosed only in extended labeling, investigator brochures, or procurement documentation, not in the standard public record.

Practical supplier categories for RADICAVA ORS procurement

1. NDA holder and product commercialization supplier (company controlling supply and distribution agreements).
2. Finished dose drug product manufacturer(s) (tablet/suspension manufacturing and aseptic/nonsterile fill-and-finish where applicable).
3. Packaging and labeling suppliers (often contracted).
4. Clinical supply vs commercial supply manufacturers (same or different sites depending on tech transfer).

What is the Orange Book status of RADICAVA ORS and which companies are listed?

Answer: RADICAVA ORS is an FDA-approved listed drug with Orange Book entry tied to edaravone. The record ties to an NDA and lists patent and exclusivity information, but does not reliably expose the full upstream API supplier.

Orange Book fields that matter for supplier mapping

• NDA number (anchor for product identity).
• Dosage form (oral suspension).
• Applicant/Holder (primary entity on record).
• Patent owners (often different from the commercial supply holder).
• Exclusivity periods (helps infer what competitors can launch, which can indirectly impact who is “supplying” via supply agreements and authorized distributors).

Which manufacturers are named on RADICAVA ORS labeling for the finished product?

Answer: The finished-product manufacturer is identified in RADICAVA ORS labeling (package insert and labeling section), not in the Orange Book itself. That labeling typically names one or more manufacturers and addresses for drug product manufacturing.

Why labeling matters more than patents for “supplier”

• Patents identify IP owners, not manufacturing sites.
• Labeling identifies who produced the dosage form that reaches the patient.

Dose form specific procurement implications

• RADICAVA ORS is an oral suspension, so supply includes:
  • suspension formulation and compounding,
  • batching and blending,
  • container closure system compatibility,
  • distribution under storage conditions specified on label.

Who provides edaravone API used for RADICAVA ORS?

Answer: Public records generally do not name the edaravone API supplier as a discrete entity in the Orange Book. The most reliable publicly citable sources for API sourcing require disclosure in labeling, regulatory submissions, or published procurement documents, which are not consistently public.

How to assess API sourcing risk without public API supplier disclosure

• Check whether the labeling explicitly states “manufactured for” vs “manufactured by.”
• Track whether there are multiple finished-product manufacturing sites that imply multiple supply chains.
• Monitor FDA CMC inspection outcomes if publicly reported by FDA (not consistently available for every product).

What contract manufacturing and packaging suppliers support RADICAVA ORS supply?

Answer: Contract manufacturing and packaging suppliers are commonly used in oral suspension supply chains, but the identities of contract manufacturers are rarely fully listed in the Orange Book. They may be named only in labeling manufacturing sections or on packaging labels.

Common manufacturer roles in oral suspension products

• Drug product manufacturer (compounding, blending, filling).
• Primary packaging manufacturer (bottles, caps, liners).
• Secondary packaging and kitting (cartons, labels, dosing devices if any).
• Cold-chain or room-temperature warehousing (depends on label storage).

How do supplier and contract changes affect RADICAVA ORS continuity of supply?

Answer: Changes in finished-product manufacturing sites can occur via supplements to the NDA. Supplier changes typically impact:

• release testing location and quality systems,
• shipping lane and warehousing partners,
• batch record and analytical method transfer timelines.

Timing indicators

• NDA manufacturing supplement approvals.
• CMC supplement filings with revised manufacturing sites (publicly visible through FDA supplement histories, when indexed).

Which distributors supply RADICAVA ORS to pharmacies and hospitals?

Answer: Distributors for brand products are usually the NDA holder’s designated distribution network or authorized wholesalers. Exact distributor names are typically shown on:

• pharmacy ordering catalogs,
• wholesale distribution agreements,
• NDC distribution listings. Public sources do not consistently expose distributor identity through Orange Book records.

Procurement reality

• In practice, “supplier” for hospitals often means the wholesaler or GPO channel supplier.
• The NDA holder controls primary supply, while wholesalers handle channel distribution.

RADICAVA ORS supplier landscape vs RADICAVA (injection): who’s different across products?

Answer: The RADICAVA portfolio includes edaravone injection and edaravone oral suspension. Supplier networks can differ because:

• injection requires sterile manufacturing and filling controls,
• ORS uses nonsterile suspension manufacturing and different packaging validation.

Where supplier differences show up

• labeling manufacturing section may name different finished-product sites for injection vs ORS,
• quality and testing labs may differ,
• logistics partners may differ based on product storage and shipping classification.

Key Takeaways

• RADICAVA ORS “suppliers” can be mapped with high confidence only to the FDA-listed applicant/holder and the finished-product manufacturer named in labeling.
• Upstream API supplier identities are not reliably disclosed in Orange Book records and are typically not citable without labeling or additional regulatory disclosures.
• For procurement, the actionable supplier map is:
  1. NDA holder controlling supply,
  2. finished-product manufacturer(s) named in RADICAVA ORS labeling,
  3. wholesalers/distributors through standard NDC channel listings.

FAQs

1. Is Biogen the NDA holder for RADICAVA ORS?
2. Do Orange Book records list the finished-product manufacturer for RADICAVA ORS?
3. Can the edaravone API supplier be identified from FDA public databases for RADICAVA ORS?
4. Do RADICAVA injection and RADICAVA ORS share the same manufacturing sites?
5. Where can hospitals verify RADICAVA ORS channel distributors for ordering?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. FDA.
2. FDA. Labeling and prescribing information for RADICAVA (edaravone) oral suspension (RADICAVA ORS). U.S. FDA.