Aurobindo Pharma Ltd. — Regulatory Filings 2021

Dec 28, 2021

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To	To
ListingDepartment,	TheCorporateRelationsDepartment
NATIONALSTOCKEXCHANGEOFINDIALIMITED	BSELIMITED
ExchangePlaza,	PhirozJeejeebhoyTowers,
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MUMBAI-400051	MUMBAI-400001
Company Code No. AUROPHARMA	**Company Code No. 524804 **

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----- Start of picture text ----- Press Release----- End of picture text -----

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Hyderabad, India, December 28, 2021

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----- Start of picture text ----- Aurobindo announces DCGI’s permission to manufacture and market its generic version ofMolnupiravir to be marketed as Molnaflu®, licensed from MSD and Ridgeback----- End of picture text -----

Aurobindo Pharma Limited (along with its subsidiaries together referred to as “Aurobindo”) is pleased to announce the receipt of the DCGI’s (Drugs Controller General of India) permission to manufacture and distribute its in-licensed generic version of MSD (a trade name of Merck & Co., Inc, Kenilworth, NJ, USA) and Ridgeback’s Molnupiravir, to be marketed as Molnaflu®. Earlier this year, Aurobindo had signed a non-exclusive voluntary licensing agreement with Merck Sharpe Dohme, Singapore (MSD), a subsidiary of Merck & Co. (US) to manufacture and supply Molnupiravir to over 100 low and middle-income countries (LMIC), including India.

Molnupiravir is the first oral antiviral approved by the UK Medicines and Healthcare products Regulatory Agency (UKMHRA) for the treatment of mild-to-moderate COVID -19 in adults. It has also been recently approved by the U.S. Food and Drug Administration (USFDA) and under Emergency Use Authorisation (EUA). Last week, Japan’s Ministry of Health, Labor and Welfare (MHLW) granted Special Approval for Emergency in Japan for Molnupiravir for infectious disease caused by SARS-CoV-2.

Mr. K. Nithyananda Reddy, Vice Chairman, Aurobindo said, “We are delighted with the timely permission from DCGI for the generic version of Molnupiravir as it opens up access to an affordable treatment option for COVID19 patients and enable us to help battle the pandemic with effective and high-quality pharmaceutical products. We are glad to have partnered with MSD on this product and are committed to enhance access to this product for patients in need, in our partnered territories. The product progresses our mission of being committed to healthier life”.

For the generic version of Molnupiravir, Aurobindo enjoys backward integration with in-house API manufacturing which equips it with stronger control on supply chain and cost efficiencies. The product will be manufactured at the Company’s manufacturing facilities in India that are approved by global regulatory agencies including USFDA and UKMHRA. The Company has adequate capacities to meet the global demand across the 100 plus LMIC for the product.

The DCGI, based on the review of clinical data of Molnupiravir has given permission to manufacture and market anti COVID-19 pill Molnupiravir for restricted emergency use for treatment of adult COVID-19 patients in India, subject to certain conditions.

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----- Start of picture text ----- About Aurobindo Pharma Limited----- End of picture text -----

Aurobindo Pharma Limited (www.aurobindo.com), (NSE: AUROPHARMA, BSE: 524804, Reuters: ARBN.NS, Bloomberg: ARBP IN) is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 155 countries.

The company has 27 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The company’s robust product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, Anti-

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Corp. Off.: Galaxy, Floors: 22-24, Plot No.1, Survey No.83/1, Hyderabad Knowledge City, Raidurg Panmaktha, Ranga Reddy District, Hyderabad – 500 032, Telangana, India. Tel : +91 40 6672 5000 / 6672 1200 Fax: +91 40 6707 4044. Regd. off.: Plot No. 2, Maithrivihar, Ameerpet, Hyderabad - 500 038 T.S., INDIA Tel: +91 40 2373 6370/ 2374 7340 Fax: +91 40 2374 1080 / 2374 6833

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Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.

To know more, please log on to www.aurobindo.com

For further information or queries, please contact:

Arvind Bothra Head - Investor Relations | Corporate Communications Phone: +91 40 66725401 / 66725000 Email: ir@aurobindo.com

Disclaimer:

This press release contain statements that may constitute “forward looking statements” including and without limitation, statements relating to product characteristics and uses, sales potential and target dates for product launch, implementation of strategic initiatives, and other statements relating to our future business developments and economic performance. While these forward-looking statements represent our judgment and future expectations concerning the development of our business, a number of risks, uncertainties and other factors could cause actual developments and results to differ materially from our expectations. The company undertakes no obligation to publicly revise any forward-looking statements to reflect future events or circumstances and will not be held liable for any use of this information.

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Corp. Off.: Galaxy, Floors: 22-24, Plot No.1, Survey No.83/1, Hyderabad Knowledge City, Raidurg Panmaktha, Ranga Reddy District, Hyderabad – 500 032, Telangana, India. Tel : +91 40 6672 5000 / 6672 1200 Fax: +91 40 6707 4044. Regd. off.: Plot No. 2, Maithrivihar, Ameerpet, Hyderabad - 500 038 T.S., INDIA Tel: +91 40 2373 6370/ 2374 7340 Fax: +91 40 2374 1080 / 2374 6833