Last updated: May 27, 2026
Opfolda (efanesoctocog alfa) suppliers: Who manufactures the drug substance and finished product?
Opfolda is a recombinant factor VIII (FVIII) gene-variant fusion protein produced and supplied through biologics manufacturing networks used for FDA-approved FVIII replacement therapies. The specific contract manufacturing and fill-finish suppliers for Opfolda are not disclosed in public sources in a way that permits an accurate, complete mapping from “drug substance supplier” to “finished product supplier” for each lot.
What companies supply Opfolda to US hospitals and specialty pharmacies?
No public, comprehensive supplier attribution is available for Opfolda’s biologic drug substance and final drug product by named external manufacturing companies.
Who is the marketing authorization holder for Opfolda in the US?
- The FDA marketing authorization holder for Opfolda is not identified here with supplier-level precision because public records that would connect the marketing authorization to named manufacturing vendors for drug substance and fill-finish are not provided in the available record.
How does Opfolda distribution work without named suppliers?
- Opfolda is distributed as a specialty biologic. The “supplier” customers typically care about for contracting and supply continuity are the manufacturer of record (drug product) and the supply chain for biologic drug substance. Those names are not provided in the available material with sufficient specificity to produce a correct supplier list.
What manufacturers produce Opfolda drug substance (API) vs finished drug product?
Featured snippet answer: A public, supplier-by-vendor breakdown for Opfolda drug substance versus finished product is not available in the provided sources.
Drug substance: what is typically outsourced for FVIII fusion proteins?
For gene-variant or fusion FVIII proteins, supply chains typically split into:
- Upstream cell culture and harvest (bioreactors)
- Purification and formulation into drug substance
- Drug product fill-finish into the final vial format
However, the vendor names for Opfolda’s upstream, purification, or fill-finish steps are not disclosed in the provided record in a way that can be mapped to named “suppliers.”
Drug product: what dosing forms does this affect?
- Opfolda is administered as an IV infusion for hemophilia A. Supplier mapping would need to differentiate:
- vial strength
- dilution/excipients
- fill-finish site qualifications
These details are not provided in the available material.
What patents, filings, or FDA documents list Opfolda manufacturing sites?
Featured snippet answer: Named manufacturing suppliers and sites for Opfolda are not included in the available information.
Does the FDA approval package identify the contract manufacturing sites?
- FDA reviews and Chemistry, Manufacturing, and Controls (CMC) sections can contain manufacturing site lists.
- The necessary site and vendor data is not included here.
Are manufacturing sites listed in FDA labels or prescribing information?
- Labels sometimes include manufacturer of record and may not name all contract manufacturing organizations.
- No label text or FDA listing content is provided in the available record.
How to identify Opfolda suppliers in practice (using public datasets)?
Featured snippet answer: Use FDA product and inspection datasets, then validate against CMC sections in the approval package. No supplier names can be extracted from the provided material.
Data sources that usually reveal biologics manufacturing suppliers
- FDA labeling and product labeling sections (manufacturer of record)
- FDA biologics license application (BLA) and CMC summaries (approval packages)
- FDA establishment inspection listings (for biologics facilities)
These sources are not present in the provided record, so a supplier list cannot be produced accurately.
Which Opfolda suppliers matter for procurement, tendering, and continuity?
Featured snippet answer: Procurement decisions typically hinge on the manufacturer of record and the qualified fill-finish site(s). Vendor names are not available in the provided record.
Supply risk considerations for biologic suppliers
- Single-site dependence for fill-finish can constrain availability during facility shutdowns.
- Drug substance purification capacity can constrain release timelines.
- Lot release and stability can affect distribution lead times.
Supplier-level mapping is required to quantify these risks, and it is not available in the provided material.
Key Takeaways
- A named supplier list for Opfolda (drug substance and finished product) cannot be produced from the information provided.
- Supplier identification for Opfolda in real transactions typically relies on FDA CMC/manufacturing-site content and establishment inspection records, but those data are not included here.
FAQs
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Who is the manufacturer of record for Opfolda in the US label?
Not identified in the available record.
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Are Opfolda drug substance and fill-finish done by the same manufacturer?
Not determinable from the available information.
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Where can Opfolda manufacturing sites be verified publicly?
Via FDA labeling/approval package and FDA establishment inspection datasets, but supplier names are not extractable from the provided record.
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Do biosimilar or competitor entry plans affect Opfolda supplier choices?
Not addressed by the provided material.
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What documentation do hospitals request to assess Opfolda supply continuity?
Typically manufacturer-of-record details, lot release timelines, and stability/traceability documentation; vendor names are not provided in the available record.
References (APA)
- FDA. (n.d.). Drug and biologic product labeling and related regulatory materials for Opfolda (efanesoctocog alfa). U.S. Food and Drug Administration.
- FDA. (n.d.). Establishment registration and inspection records for biologics manufacturing facilities. U.S. Food and Drug Administration.
