Caplin Point Laboratories Arm Receives FDA Approval For Generic Difluprednate Eye Drops

Caplin Point Laboratories Ltd, founded in 1990 and located in Chennai, is an Indian pharmaceutical firm dedicated to the manufacturing, marketing, and export of generic medications. The company primarily serves emerging markets in Latin America, Africa, and Southeast Asia, offering a wide array of dosage forms such as tablets, capsules, liquids, ointments, and powders.

Caplin Steriles Ltd Secures US FDA Approval

On December 16, 2024, Caplin Point Laboratories Ltd announced that its subsidiary, Caplin Steriles Ltd, has obtained approval from the US Food and Drug Administration (FDA) for its generic version of Difluprednate eye drops, which are used for treating inflammation and pain linked to ocular surgery. 

The FDA approval relates to the abbreviated new drug application for Difluprednate Ophthalmic Emulsion 0.05%, as noted in a regulatory filing by Caplin Point Laboratories.

Company Statement

The product is a generic therapeutic equivalent to the reference-listed drug DUREZOL from Sandoz Inc. “We are delighted to have received first-cycle approval for this complex emulsion product. Several additional emulsion and suspension products are either filed or under development, which will enhance Caplin Steriles’ portfolio in the US and emerging markets,” stated Caplin Chairman CC Paarthipan.

Difluprednate ophthalmic emulsion, available at a concentration of 0.05% as eye drops, is a topical corticosteroid used for managing inflammation and pain following eye surgery, as well as treating intraocular inflammation. According to data from IQVIA, the company reported that Difluprednate ophthalmic emulsion, 0.05%, achieved sales of around $21 million in the United States for the 12 months ending in October 2024.

Caplin Point Laboratories Q2 FY25 Results 

Caplin Point Laboratories saw a rise of 1.46%, reaching ₹2,128.15, as the company’s consolidated net profit increased by 14.04% to ₹130.80 crore. This growth was supported by a 17.81% rise in revenue from operations, which amounted to ₹483.10 crore in Q2 FY25 compared to Q2 FY24.

Caplin Point Laboratories Share Price Performance 

The share price of Caplin Point Laboratories Ltd. closed at ₹2,440.00 at 3:30 PM on the NSE today.

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