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DR REDDYS LABORATORIES LTD — Regulatory Filings 2021
Jan 15, 2021
30528_rns_2021-01-15_6b2c1b06-1524-46db-b89d-45682bbe780b.pdf
Regulatory Filings
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January 15, 2021
Corporate Relationship Department National Stock Exchange of India Ltd. BSE Limited "Exchange Plaza" Mumbai – 400 001 Mumbai – 400 051 Fax Nos.: 022-22723121 / 22723719 / Fax Nos.: 022-26598120/ 26598237/ 22722037 / 22722039 26598238
Dalal Street, Fort Bandra-Kurla Complex, Bandra (East),
Scrip Code: 500124 Scrip Code: DRREDDY-EQ
Dear Sirs,
Sub: Press Release
Please find enclosed a Press Release on "Dr. Reddy's receives approval to conduct Phase 3 clinical trial for Sputnik V vaccine in India."
This is for your information.
With regards,

Sandeep Poddar Company Secretary
Encl: As above
CC:- New York Stock Exchange Inc.(Stock Code :RDY) NSE IFSC Ltd

DR. REDDY'S LABORATORIES LTD. 8-2-337, Road No. 3, Banjara Hills, Hyderabad - 500034. Telangana, India.
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Dr. Reddy's receives approval to conduct Phase 3 clinical trial for Sputnik V vaccine in India
Hyderabad, India, January 15, 2021 For Immediate Release
Hyderabad, India, January 15, 2021: Dr. Reddy's Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) announced today that it has received approval from the Drugs Control General of India (DCGI) to conduct phase 3 clinical trial for the Sputnik V vaccine in India.
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The phase 3 study of Sputnik V will be conducted on 1500 subjects as part of the randomized, doubleblind, parallel-group, placebo-controlled study in India.
Earlier, the Data and Safety Monitoring Board (DSMB) reviewed the safety data from the phase 2 clinical trial of the vaccine and recommended the phase 3 recruitment. In its report, the DSMB concluded that no safety concerns were identified and the study met the primary endpoints of safety.
G V Prasad, Co-chairman and Managing Director, Dr. Reddy's Laboratories said, "This is an important milestone in the progress of this pivotal clinical trial of the vaccine. We expect to commence the phase 3 study within this month and will continue to fast-track our efforts to bringing in a safe and efficacious vaccine for the Indian population".
In September 2020, Dr. Reddy's partnered with Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V vaccine and for its distribution rights in India.
Sputnik V developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world's first registered vaccine against COVID-19 based on the established human adenoviral vector platform. The vaccine's efficacy is confirmed at 91.4% based on data analysis of the final control point of clinical trials in Russia. Currently, the vaccine's clinical trials are underway in the UAE, Egypt, Venezuela and Belarus while it has been registered in Algeria, Argentina, Belarus, Bolivia and Serbia for inoculation.
……………………………………………………………………………………..……………………………………………………………………………………………………………………..………………. About Dr. Reddy's: Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy's offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy's operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com
…………………………………………………………………………………………………………………………………………………………………….. Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management's current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues**,** and (vi) the susceptibility of our industry and the markets addressed by our, and our customers', products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the

Digitally signed by SANDEEP PODDAR DN: c=IN, o=Personal, pseudonym=5baa65b04542ac0f9e3878c9d91f0db36d0548 a0, 2.5.4.20=bfda99c592e4dc5b7a2e12970b9505d6d51634ab6 09953e7b6cd73ea7af49394, postalCode=500084, st=TELANGANA, serialNumber=8185d5106ea0d6196f14ae660c09bac334f5e bc1a1790e158f29af33bf208cac, cn=SANDEEP PODDAR Date: 2021.01.15 21:58:19 +05'30'
Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2020. The company assumes no obligation to update any information contained herein."

Digitally signed by SANDEEP PODDAR DN: c=IN, o=Personal, pseudonym=5baa65b04542ac0f9e3878 c9d91f0db36d0548a0, 2.5.4.20=bfda99c592e4dc5b7a2e12970 b9505d6d51634ab609953e7b6cd73ea7 af49394, postalCode=500084, st=TELANGANA, serialNumber=8185d5106ea0d6196f14a
e660c09bac334f5ebc1a1790e158f29af3 3bf208cac, cn=SANDEEP PODDAR Date: 2021.01.15 21:59:30 +05'30'