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Cipla Ltd. Regulatory Filings 2020

Jul 27, 2020

59275_rns_2020-07-27_0b240480-531f-4ef0-99e3-9cc958e407ca.PDF

Regulatory Filings

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26[th] July 2020

(1) BSE Ltd (2) National Stock Exchange of India Ltd Surveillance Department, Surveillance 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

“ - Subject: Clarification sought with reference to the article published in the Newspaper The Economic Times”

Dear Sir / Madam,

This has reference to your email dated 24[th] July 2020 seeking clarification regarding recent news item which appeared in the “Newspaper-The Economic Times” dated July 23, 2020 captioned “Cipla all set to launch Favipiravir drug for treatment of COVID patients (Article)”, our response on the same is as follows:

Query 1.

Whether such negotiations/events were taking place? If so, you are advised to provide the said information along with the sequence of events in chronological order from the start of negotiations/events till date

We confirm that the Company received approval from the Drug Controller General of India (DCGI) for manufacturing of Favipiravir drug for treatment of Covid 19 Patients on July 22, 2020.

The Company has a duly approved policy for determination of materiality of events or information (Policy) in compliance with requirement of Regulation 30(4) of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 (LODR). All disclosures pertaining to material events or information’s, are made by the Company based on the application of materiality guidelines as stated in the Policy. The materiality guidelines clearly states the quantitative and qualitative criteria for determining the materiality of any event or information. The approval received from the DCGI for the launch of Favipiravir did not qualify as material event as per the criteria stated in the Policy as well as under Regulation 30 of the LODR, and therefore response to the other part of the query does not entail.

Please note that though the DCGI approval was not material as per the materiality guidelines stated in the Policy and was not required to be disclosed under Regulation 30, to enhance public awareness of the product offerings, the Company issued a press release dated 24[th] July 2020, captioned as “Cipla receives regulatory approval for launch of Ciplenza (Favipiravir 200 mg) in India to treat mild to moderate COVID19” after determining all relevant information e.g. tentative price, product launch date etc. The press

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release was a voluntary submission to the stock exchanges and contained relevant information relating to the product.

Query 2

Whether you/company are aware of any information that has not been announced to the Exchanges which could explain the movement in the trading, if any? Further, you are advised to provide the said information and the reasons for not disclosing the same to the Exchange earlier as required under regulation 30 of the SEBI (LODR) Regulations, 2015.

The Company is not aware of any information that has not been announced to the Exchanges which could explain the movement in the trading of shares. Please also note that the movement in the trading of shares is purely market driven and the Company has no control over it.

A detailed press release containing requisite information in this regard was released by the Company before the receipt of the above referred letter from NSE is enclosed herewith for your ready reference. As explained in our reply to query no. 1, the approval received from DCGI for the launch of Favipiravir did not qualify as a material event as per the Policy as well as under Regulation 30 of the LODR and therefore the same was not disclosed to the stock exchanges immediately upon receipt of the approval.

Query 3

The material impact of this article on the Company.

To the best of our understanding the newspaper article had no material impact on the Company.

We assure you that the Company follows highest standards of governance and compliance norms, and timely disclosures are made to the stock exchanges under applicable regulations including Regulation 30 of the LODR.

Thanking you,

Yours faithfully, For Cipla Limited

Digitally signed by RAJENDRA CHOPRA DN: c=IN, o=Personal, RAJENDRA 2.5.4.20=4987ad48c3965cfde78c8ea69e6f40ac91535876f12ba1fa5ba45cc5cc8db6 cb, postalCode=122001, st=HARYANA, serialNumber=0be85c0408d0e3afd66366 CHOPRA 9f5314248a72fdcdf34d01d48d472d7cf9262696f6, cn=RAJENDRA CHOPRA Date: 2020.07.26 22:42:46 +05'30'

Rajendra Chopra Company Secretary

Encl: as above

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Press Release

Cipla receives regulatory approval for launch of Ciplenza (Favipiravir 200 mg) in India to treat mild to moderate COVID-19

Mumbai, India; July 24, 2020: Cipla Limited (BSE: 500087; NSE: CIPLA EQ, hereinafter referred to as “Cipla”), today announced that it has been granted regulatory approval by the Drug Controller General of India (DCGI) for the launch of Favipiravir in the country under the brand name Ciplenza. The accelerated approval for manufacturing and marketing of the drug is aimed at meeting the urgent and unmet medical need for COVID-19 treatment options in the country through restricted emergency use.

As part of its efforts to enable speedy access to cater to the demand, Cipla will commercially launch Ciplenza in the first week of August priced at Rs 68 per tablet. To ensure fair and equitable distribution of the drug, supplies will be undertaken predominantly through hospital channels and via open channels, prioritised for regions with a high burden of COVID-19 cases.

The drug has been jointly developed by Cipla and CSIR-Indian Institute of Chemical Technology (IICT). As part of this partnership, CSIR-IICT has successfully developed a convenient and cost-effective synthetic process for Favipiravir. The entire process and Active Pharmaceutical Ingredient (API) of the drug has been transferred to Cipla to manufacture and market the drug at scale.

Favipiravir is an off patent, oral anti-viral drug that has been shown to hasten clinical recovery in COVID -19 patients with mild to moderate symptoms.

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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, antiretroviral, 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’20), 3[rd] largest in the pharma private market in South Africa (IQVIA MAT June’20), 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 deeprooted 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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