Suppliers and packagers for qalsody

qalsody

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Biogen Ma	QALSODY	tofersen	SOLUTION;INTRATHECAL	215887	NDA	Biogen Inc.	64406-109-01	1 VIAL, SINGLE-USE in 1 CARTON (64406-109-01) / 15 mL in 1 VIAL, SINGLE-USE	2023-04-25

Suppliers and packagers for qalsody

Last updated: June 9, 2026

Qalsody (Relyvrio) Suppliers: Who Manufactures and Supplies the Drug, API, and Finished Dosage Form?

Qalsody (to be supplied under the Qalsody brand) is sourced through a defined commercial and manufacturing chain tied to the underlying marketing authorization holder and contract manufacturing network. Suppliers for Qalsody products include the marketing authorization holder and its approved contract manufacturing organizations for drug substance (API) and drug product, plus logistics and specialty distribution partners used for cold-chain or controlled handling where applicable.

What is Qalsody? Qalsody is the brand name for sodium phenylbutyrate/taurursodiol used in ALS. The supplier set is anchored to the original developer and its supply chain approvals, and any substitution typically follows approved ANDA/505(b)(2) or compounding pathways, which are not applicable to branded prescription supply in routine distribution.

Bottom line for procurement and partnering: The “supplier” list you need for Qalsody due diligence is typically three layers: (1) marketing authorization holder, (2) API and finished-dose manufacturers (DMF/CMC-linked), and (3) wholesalers/specialty distributors handling fulfillment. Without the specific country-specific labeling and the FDA/EMA product dossier supplier identifiers, the only complete supplier mapping is limited to the authorization holder and commonly tied manufacturing entities.

Who supplies Qalsody in the U.S. market?

In the U.S., Qalsody distribution is typically executed by the marketing authorization holder’s commercial operations and its contracted specialty wholesalers. The key supplier entities for U.S. diligence are:

• Marketing authorization holder / brand owner (responsible for labeling, distribution, and product supply)
• Finished dosage form manufacturer(s) (CMC-approved for commercial batches)
• Drug substance manufacturer(s) (CMC-linked to the DMF or listed in the application)
• Specialty distributors (fulfillment to payers, hospitals, and specialty pharmacies)

Featured snippet answer: The supplier for Qalsody is the brand owner’s approved distribution and manufacturing network, with finished-dose and API manufacturers tied to the approved NDA/CMC and specialized specialty distribution channels.

Which companies typically appear as Qalsody suppliers?

For products like Qalsody, the supplier names that matter in licensing, litigation, and procurement are the ones that appear in:

• FDA product labeling (if supplier/manufacturer is listed on packaging)
• CMC sections referencing manufacturing sites
• DMF holder and site-level information (API)
• Contract manufacturing labels for dosage form

What manufacturers make the Qalsody drug substance and finished dose?

Supplier mapping for Qalsody is best treated as two manufacturing tiers:

Drug substance (API) suppliers

Drug substance suppliers are those with:

• Approved API manufacturing sites under the NDA/DMF framework
• Control strategies for impurities, polymorphs (if relevant), and stability

Finished dose suppliers (drug product)

Finished-dose suppliers are:

• Contract manufacturers filling and packaging the oral liquid / dosing presentation used for Qalsody
• Facilities producing under cGMP with validated controls for dosing accuracy, microbial limits, and stability

How to identify Qalsody API and drug product manufacturers from regulatory records?

High-intent procurement teams pull supplier names from these record types:

• Application CMC manufacturing sections listing site addresses
• DMF references for API (if cross-referenced)
• Approved labeling sections listing manufacturer, and sometimes “manufactured for” wording
• Inspection history for relevant manufacturing sites (when tied to cGMP compliance)

Which wholesalers and specialty distributors supply Qalsody to pharmacies and hospitals?

Qalsody is distributed through:

• Specialty pharmacy channels for ALS patient populations
• Wholesaler networks that handle high-cost specialty products

For due diligence, the actionable supplier set is:

• National wholesalers used for authorized distribution
• Specialty distribution partners used for cold-chain or controlled logistics (if the product presentation requires it)
• Pharmacy fulfillment networks tied to HUB services (if offered)

Do biosimilar or generic suppliers affect Qalsody availability?

No generic supplier list is stable for a branded combination product like Qalsody unless an approved 505(b)(2) or ANDA product exists and is marketed. Until a copy is authorized and stocked, Qalsody supply is dominated by:

• The brand owner’s manufacturing and distribution chain
• Replacement only via authorized channels (not independent sourcing)

What patent or exclusivity events change the supplier landscape for Qalsody?

Patent and regulatory exclusivity typically govern who can commercialize a copy, not who can manufacture under contract. Supplier diversification occurs when:

• A licensed generic or 505(b)(2) competitor enters the market
• Contract manufacturing capacity is reallocated based on new marketing authorizations

Any supplier change due to exclusivity is trackable only once:

• Another applicant’s commercial product appears with approved labeling and a stocked launch
• Orange Book and/or public regulatory listings reflect the new holder and manufacturing sites

Key Takeaways

• Qalsody supply in the U.S. depends on the brand owner’s approved manufacturing and specialty distribution network.
• Supplier due diligence should focus on three layers: marketing authorization holder, CMC-linked API and drug product manufacturers, and specialty wholesalers/distributors.
• Generic or biosimilar suppliers do not typically affect Qalsody availability unless an authorized copy product is marketed with its own CMC package and distribution chain.

FAQs

1) What does “manufactured for” on Qalsody packaging mean for supplier identification?
It indicates the marketing authorization holder’s relationship to the contract manufacturer responsible for cGMP manufacturing and release.

2) Which records show Qalsody contract manufacturing sites for API and drug product?
NDA/CMC and DMF-linked manufacturing site disclosures, plus labeling “manufactured at”/“manufactured for” language where provided.

3) Do specialty pharmacies qualify as “suppliers” of Qalsody?
They usually function as dispensers and fulfillment intermediaries; supplier mapping for manufacturing should use API and drug product manufacturers, with pharmacies treated as distribution endpoints.

4) How can a supplier chain audit be structured for Qalsody?
Map authorization holder, API manufacturer, finished-dose manufacturer, packaging and labeling release site, then distribution partners by distribution authorization.

5) When would Qalsody supplier diversification occur?
When an additional authorized marketed product (generic/505(b)(2)) enters with its own CMC manufacturing sites and commercial distribution.

References (APA)

1. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: Qalsody product records. https://www.accessdata.fda.gov/scripts/cder/daf/
2. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/