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White Paper

Product Alert – Relugolix API

Product Alert – Relugolix API

Relugolix is a medication used for the treatment of advanced prostate cancer, endometriosis- associated pain, and uterine fibroids. It works by suppressing the production of hormones that stimulate the growth of tumors or cause pain and other symptoms associated with these conditions.

Specifically, Relugolix is a gonadotropin-releasing hormone (GnRH) receptor antagonist, which means it blocks the action of GnRH, a hormone that regulates the production of other hormones such as testosterone in men and oestrogen in women. By blocking the GnRH receptor, Relugolix reduces the levels of these hormones, which can slow or stop the growth of prostate cancer cells or shrink uterine fibroids and relieve symptoms of endometriosis.

Dr. Reddy's API Offering

  • Dr. Reddy’s synthetic process is design around of Innovator Process.
  • We plan to offer anhydrous crystalline form (innovator form) and novel and stable crystalline form (Lab samples for the same are available).
  • cGMP API manufacturing facilities, successfully inspected by international regulatory authorities (TGA, WHO GMP, KFDA, PMDA, Health Canada, ANVISA and USFDA)​.
  • Genotoxic impurity (GTI) strategy as per ICH M7 guidelines and strategy for nitrosamine impurities are under evaluation..

To know more about our API offerings, please read the Tech sheet on Relugolix API by filling 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.