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Dr. Reddy';s Laboratories announces the launch of the generic version of Nexavar (sorafenib) Tablets, USP, 200 mg in the U.S. market

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Dr. Reddy’s Laboratories Ltd. has launched Sorafenib Tablets, USP, a generic equivalent of Nexavar (sorafenib) in the U.S. market following approval from the U.S. Food and Drug Administration (USFDA). The 200 mg tablets are available in bottles of 120. CEO Marc Kikuchi emphasized the company's commitment to providing affordable medicines. This launch enhances Dr. Reddy's offerings in the oncology segment, expanding their portfolio aimed at improving patient access to critical treatments.

Positive
  • Launch of Sorafenib Tablets, a generic equivalent of Nexavar, enhances oncology portfolio.
  • Approval from USFDA signifies regulatory compliance and trust in product quality.
  • Availability in U.S. market increases potential revenue streams.
Negative
  • None.

HYDERABAD, India & PRINCETON, N.J.--(BUSINESS WIRE)-- Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Dr. Reddy’s Sorafenib Tablets, USP, 200 mg, a therapeutic generic equivalent of Nexavar® (sorafenib) Tablets in the U.S. market following the approval by the U.S. Food and Drug Administration (USFDA).

“We are pleased to launch this important generic product, illustrating our continued commitment to bring affordable generic medicines to market for patients,” says Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddy’s Laboratories Inc.

Dr. Reddy’s Sorafenib Tablets, USP, are available in 200 mg tablets in bottle count sizes of 120.

Please click here: https://drreddys.com/pil/Sorafenib-Tablets-Leaflet.pdf to see the full prescribing information.

Nexavar is a trademark of Bayer HealthCare Pharmaceuticals Inc.

RDY-0522-415

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. 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 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, 2021. The company assumes no obligation to update any information contained herein.

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INVESTOR RELATIONS

AMIT AGARWAL

amita@drreddys.com

MEDIA RELATIONS

USHA IYER

USHAIYER@DRREDDYS.COM

Source: Dr. Reddy’s Laboratories Ltd.

FAQ

What recent product did Dr. Reddy's Laboratories launch?

Dr. Reddy's Laboratories launched Sorafenib Tablets, a generic equivalent of Nexavar.

When did the U.S. FDA approve Dr. Reddy's Sorafenib Tablets?

The approval from the U.S. Food and Drug Administration (USFDA) was announced at the time of the product launch.

What is the stock symbol for Dr. Reddy's Laboratories?

The stock symbol for Dr. Reddy's Laboratories is RDY.

What are the dosage and packaging details of Sorafenib Tablets?

Sorafenib Tablets are available in 200 mg dosage in bottles containing 120 tablets.

How does the launch of Sorafenib Tablets impact Dr. Reddy's Laboratories?

The launch enhances Dr. Reddy's oncology portfolio and could increase revenue opportunities.

Dr. Reddy's Laboratories Limited American Depositary Shares

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