Alembic Pharmaceuticals rose 3.46% to Rs 518.90 after the pharma company announced that it has received final approval from the US drug regulator for its abbreviated new drug application (ANDA) Fluorouracil injection USP, Pharmacy Bulk Vial.
The ANDA approved by the US Food & Drug Administration (USFDA) is therapeutically equivalent to the reference listed drug product (RLD), Fluorouracil Injection, of Spectrum Pharmaceuticals, Inc.Fluorouracil Injection is indicated for the treatment of patients with adenocarcinoma of colon and rectum, adenocarcinoma of the breast, gastric adenocarcinoma and pancreatic adenocarcinoma.
According to IQVIA, Fluorouracil Injection USP had an estimated market size of $5 million for twelve months ended December 2022.
Alembic has a cumulative total of 182 ANDA approvals (159 final approvals and 23 tentative approvals) from USFDA.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. The company manufactures and markets generic pharmaceutical products all over the world.
The drug maker reported 29% drop in consolidated net profit to Rs 121.92 crore despite a 18.7% rise in net sales to Rs 1509.02 crore in Q3 FY23 over Q3 FY22.
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