The company's wholly owned step down subsidiary Orit Laboratories LLC has received USFDA approval for Fenofibrate tablets USP.
Share price of Alembic Pharmaceuticals rose 3.5 percent intraday Wednesday after company received USFDA approval for Fenofibrate tablets.
The company's wholly owned step down subsidiary Orit Laboratories LLC has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Fenofibrate tablets USP, 54 mg and 160 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Tricor Tablets, 54 mg and 160 mg, of AbbVie Inc. (AbbVie).
Fenofibrate tablets are indicated as an adjunct to diet to reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidaemia and for treatment of adult patients with severe hypertriglyceridemia.
Fenofibrate tablets have an estimated market size of USD 92 million for 12-month ending December 2018, as per IQVIA data.
At 11:02 hrs Alembic Pharmaceuticals was quoting at Rs 563.10, up Rs 17.70, or 3.25 percent on the BSE.For more market news, click here