Alembic Pharmaceuticals shares erase gains after rising 1%; firm gets US FDA nod for eye infection drug

Shares of Alembic Pharmaceuticals erased intraday gains to end on a flat not on Thursday, December 11. The stock rose as much as 1% to hit an intraday high of ₹893 on the BSE after the company informed exchanges that it got an approval from United States Food & Drug Administration (US FDA) for its generic version of Loteprednol Etabonate and Tobramycin ophthalmic suspension used for treatment of eye infection.

On the National Stock Exchange, Alembic Pharmaceuticals shares rose as much as 1.26% to hit an intraday high of ₹894.50.

The approval granted by the USFDA for the Abbreviated New Drug Application (ANDA) Loteprednol Etabonate and Tobramycin Ophthalmic Suspension of strength 0.5%/0.3% (5 mL and 10 mL), Alembic Pharmaceuticals Ltd said in a regulatory filing.

Alembic was granted a Competitive Generic Therapy (CGT) designation for this application. With this approval, Alembic is eligible for 180 days of CGT exclusivity upon commercialisation, it added.

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb Incorporated, the company said.

Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5 per cent/0.3 per cent, is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists, the company said.

Alembic Pharma last month received final approval for its Abbreviated New Drug Application (ANDA) Diltiazem Hydrochloride Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Cardizem Tablets, 30 mg, 60 mg, 90 mg, and 120 mg, of Bausch Health US, LLC.

According to IQVIA data for the 12 months ending June 2025 (MAT June 2025), the annual sales for Diltiazem Hydrochloride Tablets in the United States were estimated at $13.9 million.

Alembic Pharma shares ended 0.2% higher at ₹885.