Cipla gets final nod for generic ophthalmic emulsion

The drug major on Thursday announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for difluprednate ophthalmic emulsion 0.05% from the US drug regulator.

Cipla's difluprednate ophthalmic emulsion is AB-rated generic therapeutic equivalent version of Novartis Pharmaceutical Corporation's Durezol. The drug is used for the treatment of inflammation and pain associated with ocular surgery and endogenous anterior uveitis.

According to IQVIA, Durezol had US sales of approximately $106 million for the 12-month period ending June 2021. Cipla said the product will be available for shipping soon.

Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets.

On a consolidated basis, the company's net profit soared 25.41% to Rs 709.92 crore on a 26.64% jump in total revenue from operations to Rs 5,504.35 crore in Q1 FY22 over Q1 FY21.

Shares of Cipla were up 0.07% at Rs 910.85 on BSE.

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