Dutasteride is an orally active synthetic progesterone (or progestin) and a medication used primarily to treat benign prostatic hyperplasia (BPH). It can also be used to treat male pattern baldness (MPB), excessive hair growth in women, and can be used as a part of hormone therapy for transgender women. Dutasteride belongs to a class of drugs called 5-alpha-reductase inhibitors, which block the action of the 5-alpha-reductase enzymes that convert testosterone into dihydrotestosterone (DHT). It is taken by mouth.
Sterling Chemical Malta LTD. holds Certificate of Suitability n. R0-CEP 2015-258-Rev 00 issued by Quality of Medicines & HealthCare (EDQM) on 24/01/2018 for Dutasteride Form I.
US DMF for Dutasteride Form I was submitted by Sterling Chemical Malta LDT. to FDA on 23/12/2015 and the following number was assigned n. 30143.
US DMF was submitted by Sterling to FDA on 08/10/2007 and the following number was assigned n. 20918.