Glenmark Secures USFDA Nod for Progesterone Vaginal Inserts

Glenmark Pharmaceuticals has obtained USFDA approval for its generic progesterone vaginal inserts, used in fertility treatments. The product is bioequivalent to Endometrin, with a market worth USD 59.2 million annually. This approval is a key addition to Glenmark's focus on women's healthcare in the US.

Glenmark Pharmaceuticals announced that it received final approval from the US Food and Drug Administration (USFDA) for its generic version of progesterone vaginal inserts. These are primarily used in fertility treatments and are deemed bioequivalent to Endometrin vaginal inserts.

The approved product, at a strength of 100 mg, will be distributed in the US by Glenmark Pharmaceuticals Inc. The company emphasized that this approval is pivotal to their strategy in addressing woman's healthcare needs.

Citing sales data from IQVIA, Glenmark noted that the market for Endometrin 100 mg vaginal inserts reached USD 59.2 million in annual sales. This approval fortifies Glenmark's presence in the US market.

(With inputs from agencies.)