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About Roxadustat Monohydrate - Form A API

Product
  • Therapeutic CategoryNephrology

  • API Technology

    Synthetic

  • Dose Form

    Oral Solids

  • Dr Reddy's Development Status

    Available (Commercial)

  • Available Regulatory Filing

    USDMF, China DMF, Brazil DMF

Mechanism of Action

Roxadustat (FG-4592, ASP1517, Anatomical Therapeutic Classification (ATC) code B03XA05) is an orally administered small molecule drug that prevents the enzymatic degradation of HIF-1α by inhibiting the PHD enzymes. In consequence, the hematocrit rises and hemoglobin concentrations increase.

Indication

Roxadustat is indicated for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD). Build, train, & validate predictive machine-learning models with structured datasets. Avoid life-threatening adverse drug events & improve clinical decision support.

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 Roxadustat Monohydrate - Form A 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 Roxadustat Monohydrate - Form A 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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Disclaimer: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act (Bolar Exemption) and not for commercial sale.