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Dr. Reddy's Laboratories Announces the Launch of Treprostinil Injection in the U.S.

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Dr. Reddy's Laboratories Ltd. (NYSE: RDY) has launched Treprostinil Injection in the U.S., marking its introduction as a therapeutic equivalent generic version of Remodulin® (treprostinil) Injection, which has been approved by the U.S. Food and Drug Administration.

The drug is available in multiple vial strengths: 20 mg/20 mL, 50 mg/20 mL, 100 mg/20 mL, and 200 mg/20 mL. This strategic launch is positioned to enhance the company's portfolio in the cardiovascular treatment domain, reinforcing its commitment to providing affordable medicines.

For detailed prescribing information and additional insights into Dr. Reddy's offerings, please visit the company’s official website.

Positive
  • Launch of Treprostinil Injection enhances product offering in cardiovascular therapeutics.
  • Approved by U.S. FDA, ensuring compliance with regulatory standards.
  • Multiple vial strengths increase accessibility to a broader patient demographic.
Negative
  • None.

HYDERABAD, India--(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 Treprostinil Injection in the U.S. market, a therapeutic equivalent generic version of Remodulin® (treprostinil) Injection, approved by U. S. Food and Drug Administration (USFDA).

Dr. Reddy’s Treprostinil Injection is supplied as 20 mg/20 mL, 50 mg/20 mL, 100 mg/20 mL or 200 mg/20 mL vials.

Please click here to see the full prescribing information: https://www.drreddys.com/pi/150092607-Treprostinil-Injection-Leaflet.pdf

Remodulin® is a registered trademark of United Therapeutics Corporation.

RDY-0323-539

About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. 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, 2022. The company assumes no obligation to update any information contained herein.

INVESTOR RELATIONS

RICHA PERIWAL

RICHAPERIWAL@DRREDDYS.COM



MEDIA RELATIONS

USHA IYER

USHAIYER@DRREDDYS.COM

Source: Dr. Reddy's Laboratories Ltd.

FAQ

What did Dr. Reddy's Laboratories announce on April 21, 2023?

Dr. Reddy's announced the launch of Treprostinil Injection in the U.S. market.

What is Treprostinil Injection a generic version of?

Treprostinil Injection is a generic version of Remodulin® (treprostinil) Injection.

What are the available strengths of Treprostinil Injection?

Treprostinil Injection is available in 20 mg/20 mL, 50 mg/20 mL, 100 mg/20 mL, and 200 mg/20 mL vials.

Which regulatory body approved Dr. Reddy's Treprostinil Injection?

The U.S. Food and Drug Administration (FDA) approved Treprostinil Injection.

How does the launch of Treprostinil Injection affect Dr. Reddy's market position?

The launch strengthens Dr. Reddy's presence in the cardiovascular market and enhances their competitive edge.

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