Dr. Reddy's Laboratories Limited American Depositary Shares - RDY STOCK NEWS

Dr. Reddy's Laboratories has launched a therapeutic generic version of Durezol® (Difluprednate Ophthalmic Emulsion 0.05%) in the U.S. market, following FDA approval. This product is aimed at enhancing the accessibility of ophthalmic treatments. The brand and generic had U.S. sales of approximately $40 million for the twelve months ending November 2022, according to IQVIA. Dr. Reddy's Difluprednate is available in 5 ml bottles, packaged in lots of 24. The company continues to emphasize its commitment to providing affordable healthcare solutions.

Dr. Reddy’s Laboratories (NYSE: RDY) announced the successful completion of clinical studies for its proposed rituximab biosimilar candidate, DRL_RI. This milestone paves the way for filing applications in the United States, European Union, and other highly regulated markets. The biosimilar is targeting various conditions, including rheumatoid arthritis and non-Hodgkin's lymphoma. DRL_RI has already received marketing approval in India and over 25 emerging markets. The company aims to commercialize the product in the U.S. through collaboration with Fresenius Kabi while pursuing direct commercialization in Europe and beyond.

Dr. Reddy’s has achieved a significant milestone with its tocilizumab biosimilar candidate, DRL_TC, demonstrating pharmacokinetic equivalence in a Phase 1 study. The trial confirmed safety, immunogenicity, and pharmacodynamic similarity to EU and U.S. reference products. Following this success, Dr. Reddy’s is initiating a global Phase 3 study to further evaluate DRL_TC's efficacy in patients with moderate to severe active rheumatoid arthritis. The company aims to improve accessibility to high-quality biosimilar treatments for patients worldwide.

Dr. Reddy’s Laboratories announced the recognition of its largest manufacturing facility in Bachupally, Hyderabad, as part of the Global Lighthouse Network by the World Economic Forum. This achievement follows a four-year digitization journey and the launch of Project 'OpsNext,' which implemented six Industry 4.0 technologies. The facility has reported significant improvements, including 43% manufacturing cost reduction, 30% decrease in production lead time, and 41% reduction in energy consumption. Dr. Reddy's aims to enhance operational efficiency and meet ambitious ESG goals by 2030.

Dr. Reddy’s Laboratories has launched Lenalidomide Capsules, a generic version of REVLIMID®, in the U.S. Approved by the USFDA, this launch grants the company 180-day exclusivity for 2.5 mg and 20 mg strengths. The launch supports greater patient access and follows a settlement with Celgene, allowing Dr. Reddy’s to market limited amounts of the drug until January 31, 2026, when the volume limitation will be lifted. The capsules are available in various strengths, catering to diverse patient needs.

Dr. Reddy's Laboratories has announced a licensing agreement with Slayback Pharma for Brimonidine Tartrate Ophthalmic Solution 0.025%, an OTC eye drop designed to relieve redness. This agreement grants Dr. Reddy's exclusive rights outside the U.S. and positions them to enter a market valued at approximately $130 million as of June 2022. Slayback's ANDA for the product is currently under U.S. FDA review, marking a significant addition to Dr. Reddy's growing OTC eyecare portfolio.

Dr. Reddy’s Laboratories has launched Bortezomib for Injection 3.5 mg, a generic equivalent of Velcade®, in the U.S. market. This product is approved by the U.S. Food and Drug Administration. Velcade® and its generic versions garnered approximately $1.2 billion in U.S. sales for the year ending May 2022, according to IQVIA Health. The Bortezomib offering is available in a 3.5 mg per 10 mL single-dose vial for both subcutaneous and intravenous use.

Dr. Reddy’s Laboratories Ltd. has launched over-the-counter Fexofenadine HCl 180 mg and Pseudoephedrine HCl 240 mg Extended Release Tablets in the U.S., the first store-brand equivalent of Allegra-D® 24 HR. Approved by the USFDA, this product aims to enhance the company's OTC portfolio for treating nasal and sinus congestion from colds or allergies. Allegra-D® had U.S. retail sales of approximately $45 million as of May 2022. The new tablets will be available in various pack sizes.