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Dr. Reddy's Laboratories (RDY) maintains its position as a global pharmaceutical innovator through strategic developments in generic medicines, biosimilars, and active pharmaceutical ingredients. This news hub provides investors and industry professionals with essential updates on corporate milestones, regulatory filings, and market expansions.
Access real-time information about earnings announcements, partnership agreements, and product pipeline advancements. Our curated collection features official press releases covering FDA approvals, manufacturing facility certifications, and therapeutic area breakthroughs in oncology and gastroenterology.
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Dr. Reddy’s Laboratories Ltd. has launched Venlafaxine ER Tablets, which are therapeutically equivalent to Osmotica Pharmaceutical's product. The FDA approved these tablets in strengths of 150 mg and 225 mg, contributing to the U.S. market with sales around $51 million for the year ending October 2021. The new products come in bottle sizes of 30 and 90. The release includes important safety information regarding suicidality risks associated with antidepressants, emphasizing careful monitoring for patients.
Dr. Reddy's Laboratories has launched Valsartan Tablets, a generic version of Diovan® approved by the U.S. FDA. The brand had U.S. sales of approximately $150 million for the twelve months ending October 2021 according to IQVIA Health. The Valsartan Tablets are available in various dosages, including 40 mg, 80 mg, 160 mg, and 320 mg. A warning regarding fetal toxicity is included, advising discontinuation if pregnancy is detected. This launch positions Dr. Reddy’s strategically within the generic pharmaceutical market.
Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) has partnered with Prestige BioPharma Ltd. to exclusively supply and commercialize Prestige's trastuzumab biosimilar in select Latin American and Southeast Asian countries. This biosimilar, HD201, is intended for treating HER2 positive breast and metastatic gastric cancer. Prestige will manage production from South Korea, while Dr. Reddy’s handles marketing and local registrations. Both companies aim to enhance access to affordable oncology treatments in these emerging markets.
Prestige BioPharma and Dr. Reddy’s Laboratories have entered into an exclusive partnership for the commercialization of Prestige's trastuzumab biosimilar (HD201) in selected Latin American and Southeast Asian countries. This biosimilar is intended for treating HER2 positive breast cancer and metastatic gastric cancer. Prestige will supply the drug, while Dr. Reddy's will handle registrations and marketing. This collaboration aims to enhance access to affordable cancer treatment in emerging markets.
Dr. Reddy’s Laboratories has launched Ephedrine Sulfate Injection USP, a generic equivalent to Akovaz®, approved by the U.S. FDA. The U.S. market for this product generated approximately $67.5 million in sales over the last twelve months, ending August 2021. The injection is packaged in a 1 mL fill within a 2 mL single-dose vial, delivering 50 mg of ephedrine sulfate per mL. This launch aligns with Dr. Reddy’s commitment to providing affordable medications and addresses a significant market need.
Dr. Reddy’s Laboratories has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules in 2.5 mg and 20 mg strengths, with tentative approvals for other strengths. This positions the company to gain 180 days of generic drug exclusivity for these products. The approval follows a settlement with Celgene (Bristol Myers Squibb) regarding REVLIMID® patents, which also allows Dr. Reddy’s to market generic versions starting from January 31, 2026. This development aims to provide a more affordable option for patients.
Dr. Reddy’s Laboratories Ltd. has launched Carmustine for Injection, USP, a therapeutic equivalent generic of BiCNU® approved by the U.S. Food and Drug Administration. The U.S. market for BiCNU® and its generics generated approximately $19.4 million in sales for the twelve months ending August 2021. Carmustine is provided as a lyophilized powder in a single-dose package. However, it carries warnings for myelosuppression and pulmonary toxicity, necessitating careful monitoring of patients' blood counts.
Exelixis expands its oncology pipeline by exercising an exclusive option to in-license XL114, a promising anti-cancer compound, from Aurigene. The exercise involves a payment of
Aditxt, Inc. (Nasdaq: ADTX) has entered a transaction agreement to acquire AiPharma Global Holdings LLC's subsidiary, AiPharma, specializing in antiviral therapies, particularly Avigan/Reeqonus. The acquisition aims to bolster Aditxt's infectious disease segment, with a total loan amount of $15 million and share issuance of up to 65% of outstanding shares upon closing. Avigan has received marketing authorization in several countries, with a global Phase 3 trial for COVID-19 nearing completion. The transaction is subject to due diligence and necessary approvals.
Citius Pharmaceuticals, Inc. (CTXR) announced a definitive agreement to acquire Dr. Reddy's Laboratories' exclusive license for E7777, an advanced oncology immunotherapy for treating Cutaneous T-cell Lymphoma (CTCL). The acquisition involves a $40 million upfront payment, additional milestones totaling up to $110 million, and royalty payments on net sales. E7777, a reformulated version of ONTAK, is nearing FDA approval with a Biologics License Application expected by late 2022. Citius aims to enhance its pipeline and target approximately 30% of the CTCL patient population, estimated at 30,000 to 40,000 in the U.S.