Ruxolitinib phosphate is the phosphate salt form of the active pharmaceutical ingredient (API) ruxolitinib. As a selective Janus kinase 1 (JAK1) and Janus kinase 2 (JAK2) inhibitor, ruxolitinib phosphate has emerged as an important treatment for myeloproliferative neoplasms and other conditions.

Chemistry and Properties of Ruxolitinib Phosphate

Chemically, ruxolitinib phosphate is referred to as (3R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile;phosphoric acid. Its molecular formula is C17H21N6O4P and molecular weight is 404.4 g/mol. Ruxolitinib phosphate is a white to off-white powder that is freely soluble in water.

As the phosphate salt form, ruxolitinib phosphate exhibits improved aqueous solubility and bioavailability compared to the free base ruxolitinib. This makes it suitable for formulation into oral tablets and other dosage forms.

Mechanism of Action of Ruxolitinib Phosphate

Ruxolitinib works by selectively inhibiting JAK1 and JAK2 kinase activity. The JAK-STAT pathway plays a key role in cytokine and growth factor signaling, which can be dysregulated in various diseases. By blocking JAK1/JAK2 phosphorylation, ruxolitinib phosphate interferes with abnormal cell proliferation and development of conditions like myeloproliferative neoplasms.

Manufacturers of Ruxolitinib Phosphate API

There are multiple manufacturers worldwide that produce ruxolitinib API to support the global commercial demand for this important drug. Some of the major ruxolitinib phosphate API manufacturers include:

These manufacturers have established commercial-scale production facilities with the capability and certifications to deliver high-quality ruxolitinib phosphate in compliance with cGMP standards and stringent regulatory requirements of markets like the US, Europe and others.

Supply of Ruxolitinib API

Leading manufacturers like Qingmu Pharmaceutical have optimized multistep synthesis routes for ruxolitinib phosphate that achieve high yields. They provide this API in bulk packaging to customers who manufacture ruxolitinib formulations.

Every ruxolitinib phosphate API batch undergoes rigorous release testing as per pharmacopoeial monographs. Detailed certificates of analysis are also provided. Successful pre-approval inspections help ensure an adequate supply of this important generic API to regulated markets worldwide.

With continued investment, these major manufacturers aim to further grow their position as reliable global suppliers of affordable, high-quality ruxolitinib phosphate API to support patient access to this breakthrough treatment.