Dr Reddy's Lab

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

Hyderabad, 8 September: Sending the remediation steps of Dr Reddy's Laboratories Limited for a toss, German Regulatory Authory has issued six major audit observations on the company's Duvvada formulations manufacturing plant, months after the US Food and Drug Administration(US FDA) slapped the facility with Form 483 with the highest number of 13 observations in a re-inspection sought by the company.This is the second instance where Dr Reddy's manufacturing facility has fallen short of quality compliances during a month's time. The German regulatory body had told the company last month that it was not going to renew the compliance certification of Unit 2 at Bachupally in Hyderabad, thus effectively halting the product exports to the EU member countries from that plant.There are no immediate financial implications from the latest regulatory action as Duvvada facility already stopped exporting any product to Europe.The development, however, raised serious doubts over the effectiveness ..

Aripiprazole is a therapeutic equivalent generic version of Ablify tablets in the US market

Company recognised for its corporate sustainability leadership, is sole pharma firm in index of emerging markets

ANDAs comprise of complex generic products across diverse dosage forms

Most important positive for the stock will be the resolution of the US inspector issues