Shares of Glenmark Pharma gained 1.5 percent intraday on Tuesday on getting the final approval from the United States Food and Drug Administration (USFDA) for sale of menopause osteoporosis drugs.
The approval for sale of Norethindrone Acetate and Ethinyl Estradiol tablets was given to Glenmark Generics Inc USA, a subsidiary of Glenmark Generics.
Glenmark Generics Inc USA has been "...granted final abbreviated new drug approval (ANDA) from the USFDA for Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 0.5 mg/2.5 mcg and 1 mg/5 mcg. Glenmark will commence distribution of the product immediately," Glenmark said in a BSE filing.
Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 0.5 mg/2.5 mcg and 1 mg/5 mcg are Glenmark's generic version of Warner Chilcott's FemHRT, it added.
"Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 0.5 mg/2.5 mcg and 1 mg/5 mcg are indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and for the prevention of postmenopausal osteoporosis in women at significant risk of osteoporosis," the firm said.
lenmark Generics supplies APIs to customers in approximately 80 countries, including the US, various countries in the EU, South America and India.
At 12:37 hours IST, the scrip of Glenmark Pharma was quoting at Rs 849.10, up Rs 1.15, or 0.14 percent on the BSE.
(With inputs from PTI)
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