Chennai, February 26, 2025 – Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited (BSE: 524742, NSE: CAPLIPOINT), has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution (Eye Drops) in 0.2%/0.5% strength with 5mL, 10mL, and 15mL fill presentations. This product is a generic equivalent of COMBIGAN, originally developed by AbbVie Inc.
Market Potential and Indication
Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution are indicated for reducing intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. According to IQVIATM (IMS Health), the US market for this drug recorded sales of approximately $242 million for the 12 months ending December 2024.Caplin Steriles' Expansion in the US Market
Caplin Steriles continues to strengthen its foothold in the US pharmaceutical market. The company has developed and filed 46 ANDAs, with 34 approvals received to date. Additionally, Caplin Steriles is working on an extensive pipeline of 40+ injectable and ophthalmic products slated for filing over the next four years.Global Presence
Beyond the US, Caplin Steriles has successfully expanded into Mexico, Australia, Canada, South Africa, and other regulated markets, securing multiple approvals for its product portfolio.About Caplin Point Laboratories
Caplin Point Laboratories Limited is a high-growth pharmaceutical company specializing in emerging markets across Latin America and Africa. The company is known for strong financial performance, consistently delivering robust revenue growth, profitability, and cash flow generation over the past 15 years.Caplin Point has also received several prestigious recognitions, including Forbes's "Asia’s 200 Best Under a Billion" list seven times in the past decade, as well as the Economic Times' Emerging Company of 2018 and Business Excellence Award for 2019.
