Dr Reddy

Strong US pipeline, sustained growth trajectory main trigger for Dr Reddy's

Excluding the strong US show led by Revlimid, Q2 was a mixed bag

Dr Reddy's, Cipla, and Aurobindo units recall products in US market

Leading drug firms Dr Reddy's Laboratories, Cipla and Aurobindo Pharma are recalling different products in the US market for various issues, according to the US Food and Drug Administration. As per the enforcement report by the US Food and Drug Administration (USFDA), the US-based unit of Dr Reddy's Laboratories is recalling 2,838 ampules of vitamin K deficiency treatment drug Phytonadione Injectable Emulsion. According to the USFDA, Dr Reddy's Laboratories is recalling the affected lot due to "failed stability specifications". "Out of specification results reported at 12-month stability testing for aluminum content," it stated. Dr Reddy's initiated the Class III voluntary recall on September 14 this year. As per USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences". USFDA further said the US-based arm of domestic drug major Cipla is recalling 9,041 cartons of Arformoterol ..

Dr Reddy's Lab receives USFDA approval to market Lenalidomide capsule

Dr Reddy's Laboratories on Tuesday said it has received approval from the US health regulator to market Lenalidomide capsules

Dr Reddy's re-launches Naproxen Sodium OTC Tablets in US market

Dr Reddys OTC Naproxen Sodium Tablets USP, 220 mg is an over-the-counter non-steroidal anti-inflammatory drug (NSAID) for use as a pain reliever and fever reducer.

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 stock: Good Q2, positive outlook, drug launches are key triggers

For Q2, DRL's net profit at Rs 5.04 billion, up 77 per cent year-on-year

Dr Reddy's Q2 net profit up 76.83% to Rs 5 billion on robust sales

Drug major Dr Reddy's Laboratories Friday reported a 76.83 per cent jump in its consolidated net profit at Rs 503.8 crore for the quarter ended September 30, 2018 on robust sales. The company had posted a net profit of Rs 284.9 crore in the corresponding period of the previous fiscal, Dr Reddy's Laboratories said in a filing to BSE. Consolidated revenue of the company stood at Rs 3,797.8 crore for the quarter under consideration. It was Rs 3,546 crore for the same period year ago. Commenting on the results, Dr Reddy's Co-chairman & CEO, G V Prasad said: "I am encouraged with our performance and progress in the second quarter. Our continuous focus on execution, operational efficiency and cost optimisation are showing results." Looking ahead, the company's priority will be to resolve pending regulatory issues, and continue to work on execution and cost structures that will enable affordable medicines for more patients, he added. Shares of Dr Reddy's Laboratories were today trading .

Dr Reddy's Q1 net profit sees six-fold growth to Rs 4.76 billion

The company has maintained visible control over the costs from manufacturing costs to general selling and R&D expenses for the second consecutive quarter

Dr Reddy's UK plant receives inspectional observations

The company's US FDA approved the site at Mirfield has two dedicated API manufacturing facilities

Regulatory woes resurface for Dr Reddy's

Duvvada facility could require second re-inspection by US FDA