Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories has received final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Difluprednate Ophthalmic Emulsion.
The approved ANDA is a generic therapeutic equivalent version of the reference listed drug (RLD) Durezol, from Sandoz Inc.Difluprednate Ophthalmic Emulsion (Eye drops) is a topical corticosteroid that is indicated in the treatment of inflammation and pain associated with ocular surgery, and in the treatment of endogenous anterior uveitis.
According to IQVIA (IMS Health), the approved drug had US sales of approximately $21 million for the 12-month period ending October 2024.
Were pleased to receive a first cycle approval for this complex emulsion product. Few more emulsion and suspension products have been filed or in the pipeline, which should augment Caplin Steriles portfolio in the US and emerging markets, commented Chairman C.C.Paarthipan.
Caplin Point Laboratories is a fast-growing pharmaceutical company with a unique business model catering predominantly to emerging markets of Latin America and Africa. The company has manufacturing facilities that cater to a complete range of finished dosage forms.
The companys consolidated net profit grew 14.04% to Rs 130.80 crore on 17.81% increase in revenue from operations to Rs 483.10 crore in Q2 FY25 over Q2 FY24.
The scrip shed 0.56% to currently trade at Rs 2,432.35 on the BSE.
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