API

In continuation to our efforts to understand the Azido impurities, we are evaluating the possibility of formation of two additional Azido impurities - Chloro methyl azido impurity and 4-Chloro azido methyl tetrazole impurity in Losartan potassium. Based on detailed synthetic landscape, it is found that these impurities are not potentially formed in our manufacturing process. The detailed assessment report for the same would be available in the coming few weeks.Dr. Reddy’s has continued to manufacture and deliver Sartan APIs in accordance with global regulations as a result of the processes and the analytical methods developed by our experts to avoid the presence of Nitrosamine and Azido impurities. We stay committed to ensure that we continue to provide high quality APIs to our partners.I will be happy to connect with you for any queries or further details on our assessment on Azido impurities in Sartan APIs. You can also log onto XCEED, our customer engagement platform, to raise any sample or technical queries on the topic.

Abiraterone is an orally active inhibitor of the steroidal enzyme CYP17A1 (17 alpha-hydroxylase/C17,20 lyase). It inhibits CYP17A1 selectively and irreversibly via a covalent binding mechanism. Abiraterone is a CYP17 inhibitor indicated in combination with prednisolone to treat patients with metastatic castration-resistant prostate cancer (CRPC) and Metastatic high-risk castration-sensitive prostate cancer (CSPC).Abiraterone Acetate (Zytiga, Janssen Biotech Inc.) was approved by the Food and Drug Administration (FDA) on April 28, 2011, for Prostate Cancer treatment. In December 2012, FDA expanded Zytiga’s use for late-stage Prostate Cancer. In February 2018, the FDA approved Abiraterone Acetate tablets with prednisone for metastatic high-risk castration sensitive prostate cancer (CSPC).As of February 2008, Abiraterone is approved in various countries worldwide for different indications.Key takeaways of Dr. Reddy’s Abiraterone Acetate API:Enough capacity to cater to current market requirements.Quality – in line with ICH guidelines.Earliest generic API manufacturer of abiraterone globally.Country-specific regulatory filingsGTI & Nitrosamine free.To know more about our offerings , please read the technical sheet on Abiraterone Acetate by filling the contact form below.

Dr. Reddy’s is among the earliest generic API manufacturers globally for Rivaroxaban API and filed the USDMF in March 2014. Dr. Reddy’s process involves a selective and efficient chemical transformations that offer distinctive advantage for quality and manufacturability. The process eliminates the potential impurities formed in the process, and can be robust and safely operated at a commercial scale.In selected markets, we can also provide the formulated drug product of Rivaroxaban and will support you in all regulatory aspects from filing to registration.To know more about our Rivaroxaban offerings, read the tech sheet by filling the contact form below.