Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, 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), available in 5mL, 10mL, and 15mL fill presentations. This medication is a generic therapeutic equivalent of COMBIGAN, developed by Abbvie Inc.
Indication and Market Opportunity
Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution is used to reduce elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. According to IQVIA (IMS Health), this medication had US sales of approximately $242 million for the 12-month period ending December 2024, highlighting the significant market potential for Caplin Steriles.
About Caplin Steriles
Caplin Steriles Limited is a rapidly expanding sterile product manufacturer with regulatory approvals from agencies including US FDA, EU-GMP, ANVISA, and INVIMA. The company has developed and filed 46 ANDAs in the United States, with 34 approvals to date. Caplin Steriles is also advancing its portfolio with over 40 injectable and ophthalmic products planned for filing in the next four years. Additionally, the company has multiple product filings and approvals in non-US markets, including Mexico, Australia, Canada, and South Africa.
About Caplin Point Laboratories
Caplin Point Laboratories Limited is a fast-growing pharmaceutical company catering primarily to emerging markets in Latin America and Africa. With state-of-the-art manufacturing facilities, the company produces a wide range of finished dosage forms. Caplin Point has demonstrated consistent profitability, cash flow growth, and revenue expansion over the past 15 years.
Caplin Point has earned multiple accolades, including being featured in Forbes’ “Asia’s 200 Best Under a Billion” list seven times in the last 10 years. Additionally, it has been awarded the “Emerging Company of 2018” and “Business Excellence Award for 2019” by the Economic Times.