Caplin Point’s Subsidiary Secures USFDA Approval for Glaucoma Eye Drops

Caplin Point Laboratories Limited announced that its subsidiary, Caplin Steriles 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).

About the Approved Drug

The approved product, available in 5mL, 10mL, and 15mL fill presentations, is a generic therapeutic equivalent of COMBIGAN by AbbVie Inc. It is indicated for reducing elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.

According to IQVIA (IMS Health), Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution had U.S. sales of approximately $242 million for the 12-month period ending December 2024.

About Caplin Point Laboratories Limited

Caplin Point Laboratories Limited is a rapidly expanding pharmaceutical company with a distinctive business model focused on emerging markets in Latin America and Africa. The company operates state-of-the-art manufacturing facilities that produce a comprehensive range of finished dosage forms. Caplin Point is among the few firms that have demonstrated consistent, high-quality growth in cash flows, profitability, and revenue over the past 15 years.

On February 27, 2025, Caplin Point share price opened at ₹1,982.25, up from its previous close of ₹1,967.35. At 9:56 AM, the share price of Caplin Point was trading at ₹1,931.25, down by 1.83% on the NSE.

Conclusion 

This approval strengthens Caplin Steriles’ presence in the U.S. ophthalmic market and enhances its portfolio of sterile injectable and ophthalmic products.

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