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Cipla Ltd. Regulatory Filings 2021

Aug 12, 2021

59275_rns_2021-08-12_eb6ad68a-5bc0-415d-a5d3-2602adef3aa0.pdf

Regulatory Filings

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12[th] August 2021

(1) BSE Ltd (2) National Stock Exchange of India Ltd Listing Department Listing Department Phiroze Jeejeebhoy Towers, Exchange Plaza, 5[th] floor, Dalal Street, Plot no. C/1, G Block, Mumbai - 400 001 Bandra Kurla Complex, Bandra (East), Mumbai - 400 051

Scrip Code: 500087 Scrip Code: CIPLA EQ

  • (3) SOCIETE DE LA BOURSE DE LUXEMBOURG Societe Anonyme 35A Boulevard Joseph II, L-1840 Luxembourg

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

Dear Sir/Madam,

Please find enclosed press release dated 12[th] August 2021 for the captioned subject.

This is for your information and records.

Kindly acknowledge the receipt.

Thanking you,

Yours faithfully, For Cipla Limited RAJENDRA Digitally signed by RAJENDRA KUMAR KUMAR CHOPRA CHOPRA Date: 2021.08.12 08:10:06 +05'30' Rajendra Chopra Company Secretary

Prepared by: Juzer Masta

Press Release

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

Mumbai, India; August 12, 2021: Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and 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 Pharmaceutical 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 3[rd] largest in pharma in India (IQVIA MAT June’ 21), 3[rd] 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 paradigmchanging 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

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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 www.cipla.com or click on Twitter, Facebook, LinkedIn.

For queries, please contact :

Corporate Communications Investor Relations Heena Kanal Naveen Bansal E-Mail: [email protected] E-Mail: [email protected]

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