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Ruxolitinib Phosphate

Ruxolitinib Phosphate-API

Ruxolitinib Phosphate API

CAS Number: 1092939-17-7

About Ruxolitinib Phosphate API

Therapeutic Category
Anti-Cancer/ Oncology

API Technology
Synthetic

Dose Form
Oral Solids

Dr Reddy's Development Status
Available

Mechanism of Action

Ruxolitinib, a kinase inhibitor, inhibits Janus Associated Kinases (JAKs) JAK1 and JAK2 which mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. JAK signaling involves recruitment of STATs (signal transducers and activators of transcription) to cytokine receptors, activation and subsequent localization of STATs to the nucleus leading to modulation of gene expression.

MF and PV are myeloproliferative neoplasms (MPN) known to be associated with dysregulated JAK1 and JAK2 signaling. In a mouse model of JAK2V617F-positive MPN, oral administration of ruxolitinib prevented splenomegaly, preferentially decreased JAK2V617F mutant cells in the spleen and decreased circulating inflammatory cytokines (e.g., TNF-alpha , IL-6).

JAK-STAT signaling pathways play a role in regulating the development, proliferation, and activation of several immune cell types important for GVHD pathogenesis. In a mouse model of acute GVHD, oral administration of ruxolitinib was associated with decreased expression of inflammatory cytokines in colon homogenates and reduced immune-cell infiltration in the colon.

Indication

Jakafi is a kinase inhibitor indicated for treatment of:
•  intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis in adults. (1.1)
•  polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea.
•  steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older.

Dr. Reddy's Expertise

Headquartered in Hyderabad, India, Dr. Reddy's Laboratories is one of the leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Ruxolitinib Phosphate API. Dr. Reddy's API business is a preferred partner to pharma companies across the US, Europe, Brazil, Latin America, Japan, China, Korea, Middle East and other emerging markets.

Dr. Reddy's API business thrives on the deep technical strengths established over the last 30+ years in the development and manufacture of complex APIs such as steroids, peptides, complex long chain molecules and highly potent APIs (HPAPIs / oncology drugs). This expertise is complemented by our prowess in intellectual property and regulatory affairs which helps us consistently meet and exceed regulatory standards. Dr. Reddy's Ruxolitinib Phosphate API is the outcome of the extensive expertise in R&D, IP, and Regulatory.

A key component in helping our customers be first to market is a responsive supply chain. We achieve this by making sure that all our facilities are operating efficiently and to the latest standards of quality, safety, and productivity. A strong interconnect between business and factories allows for a quick reaction to dynamic market changes, so that we can avert shortages and meet sudden surges in demand.

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Related Resources

Product Alert – Ruxolitinib Phosphate

Product Alert – Ruxolitinib Phosphate

Ruxolitinib Phosphate

Ruxolitinib falls under the drug class known as Janus kinase inhibitors (JAK inhibitors). It is an inhibitor of the JAK1 and JAK2 protein kinases and works by competitively inhibiting the ATP-binding catalytic site on JAK1 and JAK2.

This inhibition disrupts cytokine and growth factor signalling pathways, leading to a decrease in proinflammatory cytokines and chemokines, usually elevated in myelofibrosis and other inflammatory conditions. Furthermore, JAK1 regulates interleukin 2 and 6 and TNF alpha, while JAK2 involves many cellular functions, including proliferation and differentiation.

Dr. Reddy's is an early mover in API development and planning to file the DMFs in key markets such as the US, China, Japan, Brazil, Europe, and Korea. We offer the anhydrous crystalline form (Innovator form).

Our manufacturing process has been designed to address customized particle size distribution (PSD) requirements through size reduction and crystallization techniques to meet the most desired PSDs on a commercial scale consistently. Our API is developed at cGMP API manufacturing facilities and successfully inspected by international regulatory authorities. In addition, we have adequate capacity to meet global demands.

To learn more about our API offerings, please read the product alert on Ruxolitinib Phosphate by filling in the contact form below.

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Disclaimer

No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities. Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.

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Disclaimer

No information on this website, including any reference to any product or service constitutes an offer for sale or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, in certain cases, at Dr. Reddy's sole discretion, and subject to local legal requirement, the research quantities of such products may be offered for the purpose of regulatory submissions under Section 107A of the Indian Patent Act (Bolar exemption), wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the product or service including, patent scenario in their respective markets and will be responsible for all patent related liabilities Dr. Reddy's disclaims all warranties, express or implied, including but not limited to warranties of merchantability, fitness for a particular purpose and non-infringement.