Caplin Steriles Ltd receives USFDA final approval for ANDA Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution

Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution (Eye drops), 0.2%/0.5% in 5mL, 10mL and 15mL fill presentation, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) COMBIGAN, by Abbvie Inc.

Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. According to IQVIATM (IMS Health), Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution had US sales of approximately $242 million for the 12-month period ending December 2024.

Shares of Caplin Point Laboratories Limited was last trading in BSE at Rs. 1966.90 as compared to the previous close of Rs. 1976.05. The total number of shares traded during the day was 2479 in over 783 trades.

The stock hit an intraday high of Rs. 1999.95 and intraday low of 1961.50. The net turnover during the day was Rs. 4904236.00.

Source : Equity Bulls

Keywords

CaplinPointLaboratories INE475E01026 CaplinSteriles USFDA ANDAApproval BrimonidineTartrate TimololMaleate OphthalmicSolution EyeDrops