Sun Pharma gets CDSCO Panel Nod To study Leuprolide acetate for depot suspension
Sun Pharma
New Delhi: The drug major Sun Pharma has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the bioequivalence study of anticancer drug Leuprolide acetate depot suspension 7.5mg/vial (1 Month Depot), a man-made form of gonadotropin-releasing hormone (GnRH) that is used in men to treat the symptoms of prostate cancer.
This came after the drug major Sun Pharma presented bioequivalence study protocol No. C1B03530, Version No. 01dated 18-Sep-2023.
Bioequivalence of a drug product is achieved if its extent and rate of absorption are not statistically significantly different from those of the reference product when administered at the same molar dose.
Leuprolide acetate is a synthetic nonapeptide that is a potent gonadotropin-releasing hormone receptor (GnRHR) agonist used for diverse clinical applications, including the treatment of prostate cancer, endometriosis, uterine fibroids, central precocious puberty, and in vitro fertilization techniques.
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