Dr. Reddy's Laboratories Announces the Launch of a Generic Version of Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg in the U.S. Market
Dr. Reddy’s Laboratories has launched a generic version of Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, approved by the U.S. FDA. This product is a therapeutic equivalent to Kuvan® and reflects the company's commitment to providing affordable medications. Available in 30-count cartons, it aims to expand Dr. Reddy’s portfolio in rare disease treatments. The CEO emphasizes the importance of this launch in enhancing patient access to essential medications.
- Launch of generic Sapropterin Dihydrochloride broadens product portfolio.
- Approval by U.S. FDA enhances credibility and market access.
- Commitment to affordable medications may boost consumer trust.
- None.
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 Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, a therapeutic equivalent generic version of Kuvan® (sapropterin dihydrochloride) Powder for Oral Solution, 100 mg, USP, approved by the U.S. Food and Drug Administration (USFDA).
“We are pleased to launch this generic version of Sapropterin Dihydrochloride Powder for Oral Solution, 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. “At the same time, this product demonstrates that we are actively expanding the breadth of our portfolio with a treatment for a rare disease.”
Dr. Reddy’s Sapropterin Dihydrochloride Powder for Oral Solution, is available in 100 mg unit dose packets in a 30 count carton.
Please see the full prescribing information.
https://www.drreddys.com/pil/sapropterin_outsert_v_3.pdf
RDY-0321-334
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 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.”
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FAQ
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