Abaloparatide API Suppliers & Bulk Manufacturers
Available Forms: API (drug substance)
Available Strengths: Supplied to an in-house or pharmacopoeial specification
Reference Brands: Tymlos, Eladynos
Category: Active Pharmaceutical Ingredient
Abaloparatide is a synthetic 34-amino-acid PTHrP analogue used in injectable osteoporosis products. It is sourced by peptide formulators, CDMOs and R&D teams.
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Product Description:
Abaloparatide is a synthetic 34-amino-acid analogue of parathyroid hormone-related protein (PTHrP) that acts on the PTH1 receptor to stimulate new bone formation. It is approved for postmenopausal women with osteoporosis at high or increased risk of fracture and, in the US, also for men with osteoporosis at high risk of fracture (reference brand: Tymlos, Eladynos).
Specification at a glance
| Traded form | Synthetic peptide amide containing an alpha-aminoisobutyric acid residue; confirm the counter-ion (commonly acetate) and net peptide content |
|---|---|
| CAS number | 247062-33-5 |
| Molecular formula | C174H300N56O49 |
| Molecular weight | Approx. 3961 g/mol |
| 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 3 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: No confirmed date. European Union: Patent expiry; entry not confirmed (Dec 2032 (regulatory protection, est.)).
Handling and quality points
Abaloparatide is made by solid-phase peptide synthesis, so watch for deletion and insertion sequences, racemised residues, oxidation and deamidation products, and residual trifluoroacetic acid if the counter-ion is exchanged. The peptide should be stored frozen or refrigerated, protected from moisture, and shipped under temperature control. As it goes into a multi-dose injectable pen, bioburden and endotoxin limits need to suit parenteral use.
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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.
Abaloparatide API — third party manufacturing & bulk supply
Abaloparatide 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
Abaloparatide 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 Abaloparatide API listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.
Request a quote for Abaloparatide API →Usually answered within 48 hours, with matched manufacturers, indicative prices and document status.
Frequently Asked Questions
Buyers usually ask for the GMP certificate, a US DMF letter of access or EU ASMF, and a CoA showing purity, peptide content, counter-ion, water and residual TFA. Mass spectrometry and amino acid analysis for identity, stability data and a comparison of impurities with the reference product are also expected. An immunogenicity risk view on any impurities above about 0.1% is increasingly requested.
Peptide powders contain water and counter-ions, so the weight on the label is not all active peptide. Suppliers should report net peptide content and counter-ion levels on every batch so formulators can calculate the charge correctly. Ask whether residual trifluoroacetate from synthesis has been fully exchanged.
Yes. We put licensed manufacturers, CDMOs and research teams in contact with GMP-compliant abaloparatide makers, reviewing their documents first. PharmaTradz does not share who you are until both sides agree.
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