USFDA grants approval to Alembic Pharma for Fenofibrate capsules

Alembic Pharmaceuticals today informed the bourses that it has received a final USFDA approval for its abbreviated new drug application (ANDA) Fenofibrate capsules USP, 67 mg, 134 mg, and 200 mg.

The approved ANDA is medicinally equal to the reference listed drug product (RLD), Tricor Micronized capsules, 67 mg, 134 mg, and 200 mg, of AbbVie Inc.

Fenofibrate capsules are used to help lower ‘bad’ cholesterol and fats (such as LDL, triglycerides) and raise ‘good’ cholesterol (HDL) in the blood along with a proper diet.

Alembic Pharma has a cumulative total of 133 ANDA approvals (115 final approvals and 18 tentative approvals) from USFDA.

In the recent quarter ended June 30, 2020, Alembic pharma’s consolidated revenue for Q1FY21 came in at Rs 1,341.32 crore as against Rs 948.91 crore in the corresponding quarter last year, registering a 41.4 per cent YoY increase. EBITDA for the quarter grew by 81.1 per cent YoY to Rs 407.35 crore as against Rs 224.92 crore in the corresponding quarter last year, with a corresponding margin expansion of 667 bps. EBITDA margin for the quarter stood at 30.4 per cent. PAT for the quarter came in at Rs 292.73 crore as against Rs 119.08 crore in the corresponding quarter last year, with a YoY increase of 145.8 per cent.