Etelcalcetide Hydrochloride API Suppliers & Bulk Manufacturers
Available Forms: API (drug substance)
Available Strengths: Supplied to an in-house or pharmacopoeial specification
Reference Brands: Parsabiv
Category: Active Pharmaceutical Ingredient
Etelcalcetide hydrochloride is a synthetic peptide calcimimetic for secondary hyperparathyroidism in haemodialysis patients. Peptide formulators and CDMOs source it.
Manufacture or export Etelcalcetide Hydrochloride API? List it or send an offer →
Product Description:
Etelcalcetide is a synthetic peptide calcimimetic that activates the calcium-sensing receptor on the parathyroid gland and lowers parathyroid hormone secretion. It is approved for secondary hyperparathyroidism in adults with chronic kidney disease on haemodialysis (reference brand: Parsabiv).
Specification at a glance
| Traded form | Hydrochloride salt of a seven-residue D-amino acid peptide linked by a disulfide bond to L-cysteine; free base CAS 1262780-97-1. |
|---|---|
| CAS number | 1334237-71-6 |
| Molecular formula | C38H73N21O10S2 · xHCl (4 ≤ x ≤ 5) |
| Molecular weight | 1048.26 g/mol (free base) |
| Pharmacopoeia | No pharmacopoeia monograph found; supplied to an in-house specification. |
Regulatory files and timing
The FDA list of Drug Master Files (third quarter 2026) shows 5 active Type II API DMFs for this molecule. Few filings usually means few qualified sources, so early contact with suppliers pays off. For Europe, ask whether the supplier holds a CEP or an EU ASMF and, for imports into the EU, a written confirmation.
Generic or biosimilar entry. United States: Patent expiry; entry not confirmed (Jul 2030 (compound patent)). European Union: No confirmed date.
Handling and quality points
Etelcalcetide is made by peptide synthesis, so look closely at peptide-related impurities (deletion sequences, epimers, disulfide variants), residual counter-ions and the hydrochloride content, which the label allows to vary between four and five equivalents. The finished product is stored refrigerated, so ask for drug substance stability data and agree temperature-controlled shipping. Endotoxin and bioburden limits matter because the product is given intravenously.
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Brand names are trademarks of their respective owners and identify the reference medicine only. Information is general and was checked in October 2026; confirm specifications and filings with the supplier before purchase.
Etelcalcetide Hydrochloride API — third party manufacturing & bulk supply
Etelcalcetide Hydrochloride API is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
Indicative minimum order quantity
Etelcalcetide Hydrochloride API is supplied as API (drug substance) — a dosage form priced by order value, so the indicative MOQ is a minimum order value of USD 5,000 per product. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.
Manufacturers of Etelcalcetide Hydrochloride API listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.
Request a quote for Etelcalcetide Hydrochloride API →Usually answered within 48 hours, with matched manufacturers, indicative prices and document status.
Frequently Asked Questions
A GMP certificate, specification and CoA, and a US DMF letter of access or EU ASMF are the starting point. For a peptide like this, also ask for the impurity profile against the reference product, counter-ion and water data, endotoxin results, stability data and a nitrosamine risk assessment.
It is a synthetic peptide of D-amino acids with an L-cysteine attached through a disulfide bond, typically built by solid-phase synthesis followed by disulfide formation. Watch for deletion or insertion sequences, epimers, dimers formed during disulfide coupling and residual reagents, and expect the supplier to justify limits against the reference product.
It can. PharmaTradz connects licensed manufacturers, CDMOs and R&D teams with GMP-compliant peptide makers who produce etelcalcetide, after a check of their documents. Your details are only released when both sides agree.
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