Suppliers and packagers for vumerity

vumerity

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 Inc	VUMERITY	diroximel fumarate	CAPSULE, DELAYED RELEASE;ORAL	211855	NDA	Biogen Inc.	64406-020-03	1 BOTTLE, PLASTIC in 1 CARTON (64406-020-03) / 120 CAPSULE in 1 BOTTLE, PLASTIC	2019-10-29
Biogen Inc	VUMERITY	diroximel fumarate	CAPSULE, DELAYED RELEASE;ORAL	211855	NDA	Biogen Inc.	64406-020-07	1 BOTTLE, PLASTIC in 1 CARTON (64406-020-07) / 14 CAPSULE in 1 BOTTLE, PLASTIC	2019-10-29

VUMERITY (diroximel fumarate) Suppliers: Contract Manufacturers, API Sources, and Supply-Chain Risk Map

Last updated: May 25, 2026

VUMERITY’s supply chain is dominated by Biogen’s ownership of the product lifecycle in the US and its use of third parties for manufacturing. Publicly available patent and regulatory records do not provide a complete, verifiable list of every API and finished-dose supplier globally. The sourcing picture that can be substantiated from FDA manufacturing disclosures and related public records indicates VUMERITY is produced under controlled quality systems by contract manufacturing organizations (CMOs) listed for the drug product, with diroximel fumarate manufactured from upstream intermediates and API under regulated, audited manufacturing sites.

Which companies supply VUMERITY drug product manufacturing under FDA records?

Featured snippet answer: VUMERITY’s drug product manufacturing sites are those listed in FDA labeling/CMC disclosures associated with the marketing application holder for diroximel fumarate and its NDA manufacturing details. These typically include at least one CMO site for the finished drug product, alongside any internal Biogen sites where applicable.

What does “supplier” mean for VUMERITY in practice?

In pharma procurement, “supplier” for a prescription product usually maps to:

• API manufacturer for diroximel fumarate (upstream)
• Drug substance intermediate manufacturers (upstream)
• Drug product manufacturer (tablet/capsule manufacturing, packaging, labeling)
• Secondary packagers (bottling/blistering, cartons, labels)

For VUMERITY, the legally relevant procurement entities are the manufacturing sites named in FDA records for the NDA.

Common supplier pattern for branded oral capsules

Oral solid dose products like VUMERITY generally follow:

• centralized API synthesis and isolation
• conversion of API to a finished oral solid with a defined dissolution/particle spec
• bottle or blister packaging with serialized labeling where required

Who makes diroximel fumarate API for VUMERITY?

Featured snippet answer: The API supply for VUMERITY involves upstream manufacturers controlled through the NDA’s CMC program. The specific diroximel fumarate API company names are not fully enumerated in the patent materials alone, and only portions are reliably exposed through FDA manufacturing listings and third-party regulatory disclosures.

Why API supplier identification is harder than drug product supplier identification

• API vendors are often disclosed via DMF/letters of authorization rather than in the core label.
• NDA manufacturing site lists can reflect only drug product sites, not all upstream API sources.
• Patent assignees may be different from actual manufacturing entities.

What manufacturing sites are listed for VUMERITY capsules in the US?

Featured snippet answer: The VUMERITY capsule manufacturing sites that matter for procurement are the sites associated with the approved NDA’s drug product section in FDA records, which typically include one or more CMOs responsible for final blend, encapsulation, release testing oversight, and packaging.

How buyers validate the real supplier

Procurement teams typically triangulate:

• FDA labeling/CMC references tied to the NDA holder
• site inspection history for the manufacturing address
• supply history from QMS agreements (not public)

For VUMERITY, this triangulation is necessary because public sources do not consistently list every upstream API supplier.

Which contract manufacturers produce VUMERITY?

Featured snippet answer: The CMO(s) producing VUMERITY finished product are the manufacturing sites named for the drug product in FDA application materials tied to the NDA for diroximel fumarate.

What to look for in CMO qualification packages

When evaluating VUMERITY supply partners, buyers typically request:

• GMP certificate coverage for the named site
• batch release COAs and stability package support
• handling and packaging validation for the capsule presentation
• change control history and comparability protocols for bridging

Does VUMERITY have multiple suppliers or a single-source risk?

Featured snippet answer: Branded specialty oral products often rely on a limited set of qualified manufacturers. VUMERITY’s operational risk profile is therefore supplier-concentrated unless the NDA shows multiple approved manufacturing sites for drug product and a validated alternative for API.

Where supplier concentration shows up

• single drug product site listed for the NDA
• single API supplier relationship with limited dual-sourcing in the CMC file

How does the supply chain affect generic and biosimilar timing for VUMERITY?

Featured snippet answer: Supply chain structure does not drive exclusivity timelines. It affects launch readiness for generics through feasibility of formulation, encapsulation, and dissolution matching.

What matters for competitive supply readiness

• capsule shell compatibility and moisture handling
• diroximel fumarate particle attributes and polymorph control
• dissolution profile and bridging strategy for any reformulation

What patent or exclusivity issues intersect supplier options for VUMERITY?

Featured snippet answer: VUMERITY’s supplier ecosystem is constrained primarily by intellectual property around diroximel fumarate compositions, formulations, and manufacturing-related disclosures, and by Biogen’s exclusivity/Orange Book status for the NDA.

How procurement intersects IP

• A contract manufacturer can be willing to produce, but not legally able to support a non-infringing generic without freedom-to-operate (FTO) clearance.
• Even if a CMO can manufacture, it must handle material flows and documentation consistent with IP boundaries.

What Orange Book status is relevant to supplier change-outs?

Featured snippet answer: Orange Book listings for VUMERITY establish which patents must be navigated for abbreviated approvals. Supplier substitutions for a generic still require FTO around those listed patents.

Practical buyer implication

If a procurement plan involves alternate manufacturing for a competing product, the supplier must be able to support the legal strategy tied to the Orange Book status, not only the technical formulation.

VUMERITY supplier landscape vs. Tecfidera (dimethyl fumarate): how supply differs?

Featured snippet answer: Tecfidera and VUMERITY sit in related fumarate therapeutic classes but are different active ingredients with different formulation and manufacturing requirements. Supplier capability for dimethyl fumarate products does not automatically transfer to diroximel fumarate.

What to compare when switching vendors across fumarates

• excipient compatibility and moisture sensitivity
• encapsulation parameters and dissolution specifications
• impurity profile controls and acceptable degradation products

Key Takeaways

• VUMERITY’s supply chain is structured around the NDA’s approved drug product manufacturing sites and upstream API controls, with final “supplier” identification tied to FDA manufacturing listings tied to Biogen’s marketing authorization.
• Publicly accessible materials are not sufficient to enumerate every API and CMO supplier worldwide with full confidence using only patent texts.
• Supplier concentration risk is assessed by whether the NDA lists multiple approved manufacturing sites for drug product and whether CMC filings support validated alternative API sources.
• Any competitive supply effort (generic or reformulated product) must clear both technical feasibility (encapsulation, dissolution, impurity control) and legal constraints stemming from VUMERITY’s patent estate and Orange Book status.

FAQs

1) How do I identify the exact VUMERITY manufacturing sites from FDA records?
Use the NDA-associated drug product manufacturing site listings referenced in FDA materials tied to the approved marketing application for diroximel fumarate.

2) Can an API supplier for VUMERITY also supply dimethyl fumarate for Tecfidera?
Not automatically. diroximel fumarate and dimethyl fumarate require different synthesis routes, impurity profiles, and formulation compatibility.

3) Do VUMERITY suppliers change during the product lifecycle?
Yes, site changes can occur via CMC supplements if bridging/validation supports comparability, but the approved sites remain those reflected in FDA records.

4) What documentation should a CMO provide for VUMERITY production qualification?
GMP compliance for the named site, batch release COAs, stability data, encapsulation and packaging validation, and change control history.

5) How does patent status affect supply decisions for generic entrants?
It constrains legal ability to manufacture and market non-infringing products; procurement must be paired with an FTO strategy aligned to Orange Book-listed patents.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (diroximel fumarate entries for VUMERITY).
2. FDA. Labeling and NDA manufacturing/CMC references associated with the approved marketing application for VUMERITY (diroximel fumarate).
3. FDA. Drug Approval Package resources for diroximel fumarate (VUMERITY) NDA materials.