Bictegravir Sodium API Suppliers & Bulk Manufacturers
Available Forms: API (drug substance)
Available Strengths: USP grade or in-house specification
Reference Brands: Biktarvy
Category: Active Pharmaceutical Ingredient
Bictegravir sodium is an HIV integrase inhibitor used with emtricitabine and tenofovir alafenamide in single-tablet regimens. It is sourced by antiretroviral formulators, CDMOs and R&D teams.
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Product Description:
Bictegravir is an integrase strand transfer inhibitor that stops HIV-1 from inserting its genetic material into the DNA of host cells. It is approved only as part of a single tablet with emtricitabine and tenofovir alafenamide, used as a complete regimen for HIV-1 infection in adults and children above a minimum body weight (reference brand: Biktarvy).
Specification at a glance
| Traded form | Sodium salt; off-white to yellow solid with low water solubility; three stereocentres in the bridged ring system |
|---|---|
| CAS number | 1807988-02-8 |
| Molecular formula | C21H17F3N3NaO5 |
| Molecular weight | 471.4 g/mol |
| Pharmacopoeia | No official pharmacopoeia monograph found. Bictegravir sodium and the triple combination tablet were on the USP priority list for new monographs in 2024; supplied to an in-house specification. |
Regulatory files and timing
The FDA list of Drug Master Files (third quarter 2026) shows 8 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: Protected beyond 2033 (Apr 2036 (settlements)). European Union: Patent expiry; entry not confirmed (2033). Sources and updates are on our generic and biosimilar entry tracker.
Handling and quality points
Bictegravir has three stereocentres, so the specification needs diastereomer and enantiomer limits backed by validated chiral methods. Confirm the solid form of the sodium salt and its water uptake, as both affect blending and stability in a three-component tablet. Each partner API brings its own quality points, so plan supplier qualification for emtricitabine and tenofovir alafenamide at the same time.
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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.
Bictegravir Sodium API — third party manufacturing & bulk supply
Bictegravir Sodium 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
Bictegravir Sodium 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 Bictegravir Sodium API listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.
Request a quote for Bictegravir Sodium API →Usually answered within 48 hours, with matched manufacturers, indicative prices and document status.
Frequently Asked Questions
Typical requests are the GMP certificate, a US DMF letter of access or EU ASMF, a CoA with stereoisomer purity, XRPD and related substances, and stability data. Buyers also ask for a nitrosamine risk assessment and an ICH M7 assessment for the synthesis. For a fixed-dose product, check that each of the three API suppliers can provide matching documentation.
Yes, bictegravir sodium is sourced as a separate API and combined with emtricitabine and tenofovir alafenamide at the formulation site. Buyers usually qualify each API independently and then run compatibility and stability work on the blend. Check the patent and exclusivity position in every target market before planning commercial supply.
Yes. PharmaTradz connects licensed manufacturers, CDMOs and R&D teams with GMP-compliant makers of bictegravir sodium and its partner APIs. Documents are checked before introductions, and buyer identities stay private until both sides agree.
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