Etelcalcetide (Parsabiv) is supplied at the global scale via a narrow set of manufacturers for the active ingredient and finished drug product, with primary commercial sourcing tied to Amgen’s control of global distribution in major markets. Public, investor-grade detail on the full upstream supplier network (API houses, sterile fill-finish sites, and packaging partners) is not consistently disclosed in FDA Orange Book entries or publicly indexed regulatory datasets.
If you require the specific supplier list by API manufacturer, sterile drug product fill-finish site, and primary packager, the most defensible path is to extract named facilities and listed manufacturers from Etelcalcetide labeling, FDA establishment listings, and CMC section references on file with the NDA for each labeled presentation. That named-facility mapping is not fully available from the inputs provided here.
What companies supply etelcalcetide (Parsabiv) in finished drug form?
The drug is marketed as Parsabiv (etelcalcetide) by Amgen.
“Supplier” in the strict patent-and-regulatory sense can mean:
API manufacturers (etelcalcetide synthesis)
sterile drug product manufacturing sites (bulk drug substance to drug product conversion, vial filling, lyophilization or formulation, aseptic processing where applicable)
packaging and labeling sites (secondary packaging, kit assembly, label printing)
Publicly searchable entry points that typically name parties
FDA labeling and prescribing information “Manufactured for” and “Distributed by” lines
FDA establishment registration and listing (facility names tied to product codes)
NDA/CMC documentation referenced in postmarketing supplements (less consistently publicly indexed)
Limitation
Without a concrete, source-linked facility list for etelcalcetide, producing a supplier roster risks accuracy issues.
Who makes the etelcalcetide active pharmaceutical ingredient (API)?
Etelcalcetide is a synthetic, calcimimetic peptide administered parenterally.
API sourcing is often split across:
peptide synthesis contractors
purification and salt-form preparation
bulk intermediate handling under GMP
Limitation
Public regulatory pages do not reliably expose the named API manufacturer(s) for etelcalcetide in the same way as they do for some small molecules where the applicant lists DMF holders or site-specific manufacturing details in more accessible registries.
Which fill-finish sites produce etelcalcetide vials for Parsabiv?
Parsabiv is supplied as a sterile parenteral product, so fill-finish and aseptic/sterile operations are part of the manufacturing chain.
Fill-finish sites are usually captured by:
establishment registration listings linked to the product
labeling “Manufactured at” lines
inspection histories and CMC supplement references
Limitation
A facility-by-facility supplier table requires a named source list that is not present in the provided inputs.
What is the Orange Book status of etelcalcetide (Parsabiv) and does it list manufacturers?
Orange Book entries can show application type, exclusivity, and certain listed manufacturing details for approved drug products and dosage forms.
For biologic-like and peptide products, Orange Book listing completeness varies.
Etelcalcetide’s patent estate and exclusivity status are not the same as its manufacturing supplier network.
Answer
Orange Book status alone is not sufficient to compile a complete supplier list (API + fill-finish + packaging) with high confidence.
How do supplier chains for etelcalcetide compare with other calcimimetics (cinacalcet, doxercalciferol)?
Calcimimetics span tablets/injectables with different manufacturing footprints:
Cinacalcet hydrochloride is chemically synthesized small molecule manufacturing with different supplier patterns.
Doxercalciferol and related vitamin D analogs have their own API/sterile supply chain structures.
Etelcalcetide’s peptide nature typically concentrates sourcing in fewer specialized peptide/CDMO networks.
Business implication
Supplier risk for etelcalcetide is more likely tied to peptide synthesis capacity, sterile drug product line availability, and global cold-chain logistics than to chemical batch-to-batch scale-up.
What generic entry risks exist for etelcalcetide suppliers?
Etelcalcetide is protected by a patent estate and regulatory exclusivities that may limit generic substitution timing.
Even when a generic pathway is available, entry depends on:
formulation equivalency
sterile manufacturing capacity
analytical comparability for peptide products
facility qualification for manufacturing under GMP
Supplier implication
Incumbent supplier arrangements do not automatically block generic supply, but they can constrain capacity where only a small number of CDMOs support peptide sterile injectable programs.
Key Takeaways
Etelcalcetide (Parsabiv) is marketed by Amgen, but a complete, named “supplier list” covering API, sterile fill-finish, and packaging partners is not derivable from the information provided here without access to facility-level regulatory listings and label “manufactured by/at” disclosures.
For a defensible supplier map, you must compile named parties from labeling plus FDA establishment registrations tied to the etelcalcetide product code, then cross-check with application site CMC references.
FAQs
Which FDA facility registrations correspond to etelcalcetide sterile injectable manufacturing?
Does etelcalcetide have listed API DMF holders that name the active ingredient supplier?
What does the Parsabiv label say about “manufactured for” and “distributed by” parties?
How many distinct fill-finish sites typically qualify for etelcalcetide vials under GMP?
If a supplier changes for etelcalcetide, what CMC filings usually support the change?
References
FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-05-24).
