Last updated: April 26, 2026
Who supplies GOPRELTO (efgartigimod) for manufacturing and packaging?
GOPRELTO is the brand name for efgartigimod alfa, a neonatal Fc receptor (FcRn) inhibitor used in immunology/neuromuscular indications. Supplier identification depends on the legal “Manufactured for”/“Distributed by” statements on the finished-dose packaging, the approved product labeling, and the underlying manufacturing and labeling-and-packaging sites associated with the marketing authorization.
Available supplier-level information is not sufficient to produce a complete, accurate list of all GOPRELTO suppliers (API manufacturers, drug product manufacturers, and primary/secondary packaging partners) from the information provided.
What supplier data is required to answer the question accurately?
A correct supplier map for a branded drug normally splits into:
- API (active ingredient) suppliers: the site(s) that synthesize and release efgartigimod alfa (drug substance)
- Drug product suppliers: the site(s) that formulate and fill/finish efgartigimod alfa into the marketed dosage form (drug product)
- Packaging and labeling suppliers: primary packaging (e.g., vials/syringes), secondary packaging, and label production if disclosed
- Market authorization and product labeling entities: the companies named on the label as “manufactured for,” “distributed by,” or the marketing authorization holder
Without the actual labeling text and/or regulatory product listing that names those parties, any supplier list risks being incomplete or wrong.
Key Takeaways
- GOPRELTO is efgartigimod alfa.
- Supplier identification requires label/regulatory sources that name drug substance, drug product, and packaging/labeling parties.
- The information provided does not include those sources, so a complete supplier list cannot be produced reliably.
FAQs
1) Who makes the active ingredient for GOPRELTO?
This must be taken from drug substance manufacturing details in regulatory listings or the product label’s “manufactured by” information, which is not provided.
2) Who fills and finishes GOPRELTO for commercial supply?
This must be taken from drug product manufacturing site disclosures in approved labeling or regulatory product dossiers, which are not provided.
3) Are packaging and labeling partners listed for GOPRELTO?
They are sometimes disclosed on cartons and leaflets as labeling/packaging entities; no packaging text or regulatory listing was provided.
4) Who is listed on the GOPRELTO label as the distributor or marketing authorization holder?
This is label-specific and depends on the market; the label/distributor text was not provided.
5) Can one supplier be assumed based on efgartigimod’s origin?
No. Brand-level commercial supply chains can include multiple sites and contractors across regions; assumptions would not be accurate.
References
[1] No cited sources were provided in the prompt.
