Dr Reddy's Usfda

USFDA says 'voluntary action' required at Dr Reddy's Srikakulam unit

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 ...

Dr Reddy's launches Toripalimab to treat nasopharyngeal cancer in India

In 2023, Dr Reddy's signed a licensing and commercialisation agreement with Shanghai Junshi Biosciences for Toripalimab

USFDA issues seven observations to Dr Reddy's Hyderabad manufacturing plant

Dr Reddy's Laboratories Ltd on Tuesday said the US health regulator has issued a Form 483 with seven observations to its active pharmaceutical ingredient manufacturing facility in Bollaram, Hyderabad. "The US Food & Drug Administration (USFDA) today completed a GMP inspection at our API manufacturing facility (CTO-2) in Bollaram, Hyderabad," Dr Reddy's Laboratories Ltd (DRL) said in a regulatory filing. The inspection was conducted from November 13-19, 2024, it added. "We have been issued a Form 483 with seven observations, which we will address within the stipulated timeline," the company said. As per US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Dr Reddy's gets USFDA's inspection report for Srikakulam-based API plant

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.

Dr Reddy's Labs shares drop after US FDA gives VIA tag to Vizag facilities

Shares of Dr Reddy's Laboratories slipped up to 2 per cent at Rs 6,875.05 per share on the BSE in Monday's intraday trade

US regulators inspect Dr Reddy's, other Indian pharma majors: Report

Rivals Sun Pharma's Dadra facility and Torrent Pharmaceuticals Ltd's oncology unit are also undergoing FDA inspections

Aurobindo Pharma receives USFDA approval to manufacture Darunavir tablets

Darunavir Tablets, 600 mg, and 800 mg, in combination with other antiretroviral agents, are indicated for the treatment of (HIV-1) infection in adult and pediatric patients 3 years of age and older

Dr Reddy's Lab launches generic diabetes medication in US market

Dr Reddy's Laboratories on Thursday said it has launched a generic diabetes medication in the US market. The drug major has launched Saxagliptin and Metformin Hydrochloride extended-release tablets in the US market, the Hyderabad-based company said in a statement. The company's product is a therapeutic equivalent generic version of Kombiglyze XR tablets, it added. Dr Reddy's Saxagliptin and Metformin Hydrochloride extended-release tablets are supplied in a strength of 2.5 mg/1000 mg in bottle count of 60 and strengths of 5 mg/500 mg and 5 mg/1000 mg each in bottle counts of 30, the company said.

Dr Reddy's gains nearly 3% post completion of USFDA inspection at AP unit

The stock hit a fresh 52-week high at Rs 5,360, and has rallied over 19 per cent in less than two months.

Dr Reddy's hits 52-week high after USFDA issues EIR for Srikakulam facility

The company said, with this, all facilities under warning letter are now determined as Voluntary Action Indicated (VAI)

Dr Reddy's Laboratories to stay focussed on emerging markets for growth

Today, combined revenue from emerging markets and India finely balance that of the North America, at 38%of the total

Ranitidine cancer threat: Expect more clarity on products in coming weeks

Ranitidine sales account for 2 per cent of Strides sales and 6 per cent of its profit after tax

Dr Reddy's gets 4 observations from USFDA for Srikakulam plant

Drug major Dr Reddy's on Saturday said it has received four observations from the US health regulator USFDA for its facility at Srikakulam in Andhra Pradesh. The audit of the company's API Srikakulam Plant (SEZ) by the United States Food and Drug Administration (USFDA) was completed on Friday, the Hyderabad-based pharma major said in a regulatory filing. Dr Reddy's further said that it would address the four concerns within the stipulated timeline. "The audit of our API Srikakulam Plant (SEZ), Andhra Pradesh, by the USFDA, has been completed on October 25, 2019. We have been issued a Form 483 with four observations," said Dr Reddy's. It further said: "We will address them comprehensively within the stipulated timeline." As per the US health regulator, "an FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and ...

Dr Reddy's gets EIR, says USFDA maintained OAI status for Srikakulam plant

An OAI status is equivalent to finding of objectionable conditions at the audit site and also an indicator of regulatory and/or administrative sanctions by FDA