Baricitinib API Suppliers & Bulk Manufacturers
Available Forms: API (drug substance)
Available Strengths: USP grade or in-house specification
Reference Brands: Olumiant
Category: Active Pharmaceutical Ingredient
Baricitinib is an oral JAK1/JAK2 inhibitor used in rheumatoid arthritis, alopecia areata and other immune conditions. Generic developers, CDMOs and R&D teams source the API.
Manufacture or export Baricitinib API? List it or send an offer →
Product Description:
Baricitinib is a selective inhibitor of the Janus kinases JAK1 and JAK2, which carry signals from several cytokines involved in inflammation. In the US it is approved for moderately to severely active rheumatoid arthritis after an inadequate response to TNF blockers, severe alopecia areata and COVID-19 in certain hospitalised adults; EU approvals also cover atopic dermatitis and juvenile idiopathic arthritis (reference brand: Olumiant).
Specification at a glance
| Traded form | Free base; azetidine-containing pyrrolopyrimidine with an ethylsulfonyl group. |
|---|---|
| CAS number | 1187594-09-7 |
| Molecular formula | C16H17N7O2S |
| Molecular weight | 371.42 g/mol |
| Pharmacopoeia | No official monograph found; USP listed baricitinib as a priority new monograph in 2024 (status unverified). Otherwise supplied to an in-house specification. |
Regulatory files and timing
The FDA list of Drug Master Files (third quarter 2026) shows 7 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 (2032 (compound patent)). European Union: Patent expiry; entry not confirmed (2032 (compound patent)).
Handling and quality points
JAK inhibitors are generally handled as potent compounds, and embryo-fetal toxicity seen in animal studies supports contained handling and good personal protection. Specify the solid form, particle size and residual solvents. Ask for a nitrosamine risk assessment and for the ICH M7 assessment of mutagenic impurities from the azetidine and pyrrolopyrimidine building blocks.
Send an API enquiry All specialty APIs
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.
Baricitinib API — third party manufacturing & bulk supply
Baricitinib 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
Baricitinib 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 Baricitinib API listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.
Request a quote for Baricitinib API →Usually answered within 48 hours, with matched manufacturers, indicative prices and document status.
Frequently Asked Questions
A GMP certificate, specification, CoA and a US DMF letter of access or EU ASMF form the core. Most buyers also ask for stability data, the mutagenic impurity and nitrosamine assessments, and solid-form data.
Expect the specification to cover intermediates from the pyrrolopyrimidine and azetidine fragments, any potentially mutagenic reagents such as sulfonylating or alkylating agents, and degradation products. Ask for the ICH M7 assessment and how each named impurity is controlled.
Yes. We bring licensed manufacturers, CDMOs and R&D teams together with GMP-compliant baricitinib makers, with a check of their documents beforehand. Your identity stays confidential until both sides agree.
Related Products
Ferric Carboxymaltose API
Strength:
USP grade or in-house specification
Form: API (drug substance)
Reference Brands: Injectafer, Ferinject
View DetailsIvabradine Hydrochloride API
Strength:
Supplied to an in-house or pharmacopoeial specification
Form: API (drug substance)
Reference Brands: Corlanor, Procoralan
View DetailsBosutinib Monohydrate API
Strength:
USP grade or in-house specification
Form: API (drug substance)
Reference Brands: Bosulif
View DetailsFerric Derisomaltose API
Strength:
Supplied to an in-house or pharmacopoeial specification
Form: API (drug substance)
Reference Brands: Monoferric, Monofer
View DetailsDarolutamide API
Strength:
Supplied to an in-house or pharmacopoeial specification
Form: API (drug substance)
Reference Brands: Nubeqa
View DetailsInclisiran Sodium API
Strength:
Supplied to an in-house or pharmacopoeial specification
Form: API (drug substance)
Reference Brands: Leqvio
View DetailsLurbinectedin API
Strength:
Supplied to an in-house or pharmacopoeial specification
Form: API (drug substance)
Reference Brands: Zepzelca
View DetailsPatisiran Sodium API
Strength:
Supplied to an in-house or pharmacopoeial specification
Form: API (drug substance)
Reference Brands: Onpattro
View DetailsUsually answered within 48 hours | GMP documents shared before you commit
