Alembic Pharmaceuticals Limited has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dorzolamide Hydrochloride Ophthalmic Solution USP, 2%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Trusopt Ophthalmic Solution, 2%, of Merck Sharp & Dohme Corp. Dorzolamide Hydrochloride Ophthalmic Solution is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Dorzolamide Hydrochloride Ophthalmic Solution USP, 2% has an estimated market size of US$ 35 million for twelve months ending December 2018 according to IQVIA.
Alembic now has a total of 101 ANDA approvals (89 final approvals and 12 tentative approvals) from USFDA.
Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.538.5 as compared to the previous close of Rs. 529.95. The total number of shares traded during the day was 5901 in over 482 trades.
The stock hit an intraday high of Rs. 549 and intraday low of 531.05. The net turnover during the day was Rs. 3193857.