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White Paper

Product Alert – Abemaciclib API

Abemaciclib API

Abemaciclib is a type of drug called a selective cyclin-dependent kinase (CDK) inhibitor. It specifically targets and inhibits the activity of CDK4 and CDK6, two proteins that play a critical role in regulating cell division.

In cancer cells, the uncontrolled proliferation of cells is often driven by elevated activity of CDK4 and CDK6. Abemaciclib can disrupt the cell cycle and prevent the uncontrolled division of cancer cells by inhibiting these proteins. This can lead to cell death and slow down the growth of tumours.

Dr. Reddy's API Offering

We are targeting Innovator Form III, which is acceptable in all markets according to the patent scenario, and we can customize PSD based on your specific requirements.

Our API adheres to ICH M7 guidelines for genotoxic impurity (GTI) profiles, and we are actively evaluating strategies for nitrosamine impurities. We have also employed a robust process to achieve the consistent polymorph (innovator form) and morphology to ensure the desired in-vivo performance.

Our cGMP API manufacturing facility has undergone a thorough inspection by international regulatory authorities, and we have reliable suppliers for key starting materials to ensure timely deliveries and adherence to strict specifications. Moreover, we are equipped to provide sufficient capacity to supply development quantities within a short lead time of 90-120 days.

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

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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.