Obeda Pro and Obeda Plus are made by a different manufacturer than the original Obeda injectable, supplies of which were halted in July after Dr Reddy's discovered an impurity in active ingredients
The approval allows toripalimab with cisplatin and paclitaxel as first-line treatment for unresectable advanced, recurrent or metastatic ESCC in adults
Dr Reddy's Laboratories on Wednesday said it has received approval from the Drugs Controller General of India (DCGI) for Zytorvi (toripalimab), through which it aims to expand access to first-line immunotherapy for patients with advanced esophageal squamous cell carcinoma (ESCC) in India. The drug has been approved in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic ESCC, the pharma company said in a release. This marks Zytorvi's second approved indication in the country, expanding beyond nasopharyngeal carcinoma. ESCC accounts for approximately 80 per cent of all esophageal cancer cases in India, the company said. Zytorvi contains toripalimab, a monoclonal antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, thereby supporting T-cell activity against cancer cells. The approval is supported by results from the Phase 3 JUPITER-06 trial. In the study, toripalimab in .
The expanding domestic market for semaglutide-based weight-loss drugs is expected to help cushion weaker US sales for Cipla and Dr Reddy's after the loss of Revlimid exclusivity
Drugmaker said certain batches of semaglutide failed to meet quality specifications, prompting a delay in commercial supplies, while maintaining there is no impact on patient safety
Drugmaker Dr Reddy's Laboratories Ltd on Tuesday said it has received establishment inspection report from the US health regulator for its formulations manufacturing facility at Srikakulam in Andhra Pradesh, classifying the facility as voluntary action indicated. The US Food & Drug Administration (USFDA) had conducted a GMP and a Pre-Approval Inspection (PAI) conducted by at the company's formulations manufacturing facility FTO 11 in Srikakulam, Andhra Pradesh, India, intimated to the exchanges on July 18, 2025, Dr Reddy's Laboratories Ltd said in a regulatory filing. "We wish to inform you that the company has received the Establishment Inspection Report (EIR) on October 20, 2025. The USFDA has classified the inspection outcome as 'Voluntary Action Indicated (VAI)'," it said, adding the inspection is officially closed. Under voluntary action indicated (VAI), while objectionable conditions were found and documented during an inspection, the agency is not prepared to take or ...
In 2023, Dr Reddy's signed a licensing and commercialisation agreement with Shanghai Junshi Biosciences for Toripalimab
The company reported a 9.5 per cent fall in its consolidated net profit
Dr Reddy's Laboratories on Friday said it has received the establishment inspection report (EIR) from the US health regulator for its active pharmaceutical ingredient manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh. The US Food and Drug Administration (USFDA) has classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection is close, the Hyderabad-based drug maker said in a statement. As per USFDA, VAI means that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. On June 7 this year, Dr Reddy's had stated that the US health regulator has issued Form 483 with four observations after inspecting its Srikakulam-based facility. Shares of the company on Friday ended 0.42 per cent down at Rs 6,669.75 apiece on the BSE.
During the quarter, the company launched 5 new products, of which 4 were launched in the US. A total of 21 products were launched during the year
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Dr Reddy's Laboratories on Thursday said it has inked a pact to acquire Germany-based Nimbus Health GmbH. The drug major said it has entered into a definitive agreement to acquire the company which is a privately owned, licensed pharmaceutical wholesaler focusing on medical cannabis in Germany. Dr Reddy's will acquire Nimbus Health for an upfront payment plus performance and milestone-based earn-outs over the next four years, the Hyderabad-based drug maker said in a regulatory filing. The company however did not share financial details. The acquisition will allow Dr Reddy's to build on Nimbus Health's strengths and introduce medical cannabis-based medicines as a promising treatment option for patients, it added. "Medical cannabis is increasingly used to address and treat high unmet medical needs, especially in pain management and CNS. Further, with numerous studies being conducted to leverage and introduce medical cannabis, we believe this is a must-be field for future healthcare
Revenues stood at Rs 5,319.7 crore during the third quarter as compared with Rs 4,929.6 crore in the same period of 2020-21
A consignment, comprising as many as three million doses of Russia's COVID-19 vaccine Sputnik V, landed at the Rajiv Gandhi International Airport
Dr Reddy's would need to scale up manufacturing and obtain regulatory approval for marketing of this drug in respective countries, the company said
According to Prasad, the relevance of Indian pharma sector as a provider of affordable alternative to the world remains intact
In March this year, Dr Reddy's Laboratories had received observations from the US regulator for its Duvvada facility