Riociguat API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: Supplied to an in-house or pharmacopoeial specification

Reference Brands: Adempas

Category: Active Pharmaceutical Ingredient

Riociguat is an oral soluble guanylate cyclase stimulator for pulmonary hypertension. It is sourced by generic formulators, CDMOs and licensed importers preparing generic tablets.

Product Description:

Riociguat stimulates soluble guanylate cyclase, the enzyme that nitric oxide normally switches on, raising cyclic GMP so that the blood vessels in the lungs relax. It is approved for adults with chronic thromboembolic pulmonary hypertension that is inoperable or persists after surgery, and for pulmonary arterial hypertension (WHO Group 1) (reference brand: Adempas).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 6 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: Generics/biosimilars on the market (Oct 2026). European Union: Patent expiry; entry not confirmed (2028).

Handling and quality points

The label describes solid riociguat as stable to temperature, light and humidity, so storage is straightforward. More attention goes on crystal form, as more than one solid form is known, and on particle size, because the tablets contain very little drug and content uniformity depends on it. Riociguat carries an embryo-foetal toxicity warning, so occupational exposure controls and suitable containment for weighing and blending apply.

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.