Alembic Pharma gets USFDA approval for Ophthalmic Solution

Pharma major Alembic Pharmaceuticals received approval from the USFDA for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1%. The stocks gained around 2 per cent intraday post the news.

The United States Food and Drug Association (USFDA) has given its approval for Alembic’s Abbreviated New Drug Application (ANDA) Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% , indicated for the treatment of the signs and symptoms of allergic conjunctivitis. Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% is therapeutically equivalent to the reference listed drug product (RLD) Patanol Ophthalmic Solution, 0.1%, of Novartis Pharmaceuticals Corporation.

The IQVIA data states that Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% has an estimated market size of US$ 61 million for 12 months ending December 2017.

Alembic Pharmaceuticals Limited is vertically integrated with the ability to develop, manufacture and market pharmaceutical products, pharmaceutical substances and intermediates. Alembic is the market leader in the Macrolides segment of anti-infective drugs in India.

On Monday, the shares of Alembic opened lower at Rs. 602 per share against Friday’s close of Rs. 614.40. At 12:11 hours, the stock was trading at Rs 615.85, up by 0.24 per cent. The intraday high was Rs. 623 and intraday low was Rs. 602 per share on the BSE. Its 52-week high was Rs. 664 and 52-week low was Rs. 412.40 per share on the BSE.

Meanwhile, both the benchmark indices were in red with the BSE Sensex at 35,171.36, down by 1.41 per cent and Nifty50 at 10,538.65, down by 1.45 per cent.