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White Paper

Product Alert - Relugolix API

Product Alert – Relugolix API

CAS No: 737789-87-6

As an early mover in API development, we are committed to regulatory compliance, have DMFs filling in the US and Brazil, and plan to file the DMFs in significant markets. Our API is available in an anhydrous crystalline form (the innovator form), which can be provided in customized sizes based on your requirements. We also offer a finished dosage form of Relugolix in selected markets.

Our synthetic process ensures consistent polymorph and amorphous forms for optimal in-vivo performance. Additionally, our API adheres to ICH M7 guidelines for genotoxic impurity (GTI) profiles, and we are actively evaluating strategies for nitrosamine impurities.

To learn more about our API offerings, please read the product alert on Relugolix 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.