Cipla receives final approval for generic version of Novartis Pharmaceuticals Corporation Durezol® (Difluprednate Ophthalmic Emulsion 0.05%)


MUMBAI, India, Aug. 12, 2021 /PRNewswire/ -- Cipla Ltd. (BSE: 500087) (NSE: CIPLA EQ) (hereafter referred to as "Cipla") today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Difluprednate Ophthalmic Emulsion 0.05% from the United States Food and Drug Administration (US FDA).


Cipla's Difluprednate Ophthalmic Emulsion 0.05% is AB-rated generic therapeutic equivalent version of Novartis Pharmaceuticals Corporation's Durezol®.

 It is used for the following:

  • Treatment of inflammation and pain associated with ocular surgery.
  • Treatment of endogenous anterior uveitis.

According to IQVIA (IMS Health), Durezol® had US sales of approximately $106mn for the 12-month period ending June 2021.

The product will be available for shipping soon.

About Cipla:

Established in 1935, 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. Our strengths in the respiratory, anti-retroviral, urology, cardiology, anti-infective and CNS segments are well-known. Our 46 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT June '21), 3rd  largest in the pharma private market in South Africa (IQVIA MAT June '21), and is among the most dispensed generic players in the U.S. For over eight decades, making a difference to patients has inspired every aspect of Cipla's work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the HIV movement. A responsible corporate citizen, Cipla's humanitarian approach to healthcare in pursuit of its purpose of 'Caring for Life' and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders. For more, please visit or click on TwitterFacebookLinkedIn.

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Company Codes: Bombay:500087, OTC-PINK:CPLFY, Bombay:CIPLA.BO, India:CIPLA.NS, India:EQCIPLA

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