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Cipla Ltd. Regulatory Filings 2021

Dec 18, 2021

59275_rns_2021-12-18_4bd02cec-e0f1-4559-a39d-425f4ea2bd92.pdf

Regulatory Filings

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18[th] December, 2021

  • (1) BSE Limited (2) National Stock Exchange of India Limited 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 Lanreotide Injection

Dear Sir/Madam,

Please find enclosed press release dated 18[th] December 2021 for the captioned subject.

This is for your information and records.

Kindly acknowledge the receipt.

Thanking you,

Yours faithfully, For Cipla Limited

RAJENDR Digitally signed by RAJENDRA A KUMAR KUMAR CHOPRA Date: 2021.12.18 CHOPRA 20:55:48 +05'30' Rajendra Chopra Company Secretary

Encl: as above

Prepared by: Juzer Masta

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Cipla Receives Final Approval for Lanreotide Injection

Mumbai, India, & New Jersey, USA: December 18, 2021: Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as "Cipla")and its subsidiary Cipla USA, Inc., (hereafter referred to as “Cipla”), today announced that it has received final approval for its Lanreotide Injection, from the United States Food and Drug Administration (US FDA). The FDA approval was based on a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway. Lanreotide Injection is supplied in 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL singledose pre-filled syringes. It is indicated for the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs).

Umang Vohra (MD and Global CEO, Cipla Limited) said, “We are pleased to receive the final approval for Lanreotide injection from the USFDA. Enabling access to high-quality treatments is core to our purpose of “Caring for Life”. This approval is a significant step for our US business and is in line with our aspiration to continue growth in our complex product pipeline and address unmet patient needs.

The active ingredient, route of administration and strengths are the same as SOMATULINE DEPOT[®] , from Ipsen Biopharmaceuticals Inc. According to IQVIA, SOMATULINE DEPOT[®] had US sales of approximately $867M for the 12-month period ending October 2021.

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 wellknown. 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 October 2021), 3rd largest in the pharma private market in South Africa (IQVIA MAT October 2021), 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

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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.

Media Contacts:

Corporate Communications Investor Relations

Heena Kanal Naveen Bansal E-Mail: [email protected] E-Mail: [email protected]

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