Velpatasvir API Suppliers & Bulk Manufacturers
Available Forms: API (drug substance)
Available Strengths: USP grade or in-house specification
Reference Brands: Epclusa, Sovaldi
Category: Active Pharmaceutical Ingredient
Velpatasvir is an HCV NS5A inhibitor paired with sofosbuvir in pan-genotypic hepatitis C tablets. It is sourced by generic formulators, CDMOs and licensed importers.
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Product Description:
Velpatasvir blocks NS5A, a hepatitis C virus protein needed for replication and assembly of the virus, and is combined with sofosbuvir, a nucleotide analogue that inhibits the viral NS5B polymerase. The fixed-dose combination is approved for chronic hepatitis C genotypes 1 to 6 in adults and children aged 3 and older, with ribavirin added in decompensated cirrhosis (reference brand: Epclusa). Sofosbuvir is also used on its own alongside other antivirals (reference brand: Sovaldi).
Specification at a glance
| Traded form | Velpatasvir free base, practically insoluble above pH 5. Partner API sofosbuvir: CAS 1190307-88-0, C22H29FN3O9P, 529.5 g/mol. |
|---|---|
| CAS number | 1377049-84-7 |
| Molecular formula | C49H54N8O8 |
| Molecular weight | 883.0 g/mol |
| Pharmacopoeia | Velpatasvir: Indian Pharmacopoeia draft monograph proposed for the IP 2024 Addendum (final status unverified) and an IP monograph for sofosbuvir and velpatasvir tablets; USP lists velpatasvir as a new monograph in development. Sofosbuvir: USP monograph proposed in Pharmacopeial Forum, not yet official. No Ph. Eur. or JP monograph found (unverified). |
Regulatory files and timing
The FDA list of Drug Master Files (third quarter 2026) shows 0 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 (2033). European Union: Patent expiry; entry not confirmed (2032).
Handling and quality points
Velpatasvir is practically insoluble at neutral pH, so solid form and particle properties have a direct effect on how it performs in a tablet; confirm which solid form the supplier delivers and how it is controlled. The IP draft describes the material as hygroscopic and calls for storage protected from moisture. With several stereocentres, the specification should cover stereoisomers as well as process impurities, and for the combination product most buyers qualify the sofosbuvir and velpatasvir sources together.
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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.
Velpatasvir API — third party manufacturing & bulk supply
Velpatasvir 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
Velpatasvir 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 Velpatasvir API listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.
Request a quote for Velpatasvir API →Usually answered within 48 hours, with matched manufacturers, indicative prices and document status.
Frequently Asked Questions
Most ask for a GMP certificate, the specification and certificate of analysis, and evidence of the regulatory route: a US DMF with letter of access, an EU ASMF, or WHO API prequalification where the supplier holds it. Add stability data and residual solvent and nitrosamine risk assessments, and ask for the same set for the sofosbuvir source if you are making the combination.
Not a final one in the major pharmacopoeias, as far as we can verify. The Indian Pharmacopoeia has published a draft monograph and USP has one in development, so most material is still released against the maker's own specification set up under ICH Q6A. Check which reference standard the supplier uses for assay and related substances.
Yes. PharmaTradz connects licensed manufacturers, importers and R&D teams with GMP-compliant API producers, and we review the documents on both APIs before making an introduction. We keep your details confidential until both sides choose to proceed.
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