Dr Reddy's Labs

Dr Reddy's Laboratories Ltd on Thursday said the US health regulator has issued Form 483 with two observations after inspecting its manufacturing facility located at Srikakulam in Andhra Pradesh. As per USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The US Food and Drug Administration (USFDA) completed a pre-approval inspection at the company's formulations manufacturing facility FTO 11 in Srikakulam, Andhra Pradesh on Thursday, Dr Reddy's said in a regulatory filing. The inspection was conducted from June 30, 2022 to July 7, 2022. "We have been issued a Form 483 with two observations, which we will address within the stipulated timeline," the company added.

Dr Reddy's Laboratories on Thursday said its subsidiary has inked a pact with US-based Olema Pharmaceuticals Inc to research, develop and commercialise novel small molecule inhibitors of a target

Sputnik Light has not yet received emergency use authorisation from the DCGI

The overall chart pattern of Asian Paints indicates that the prevailing momentum is likely to continue

At 02:17 pm, Dr Reddy's Labs market cap stood at Rs 90,348 crore while that of Divi's Laboratories stood at Rs 89,119 crore, BSE data show

The company's consolidated revenues rose 15 per cent to Rs 4,418 crore, mainly due to growth in US formulations

Around 50 companies including the likes of Maruti Suzuki, Nestle, Dr Reddy's Labs, Biocon, and Bandhan Bank are scheduled to announce their March quarter results.

Earnings were driven by one-off gains

The potential revenue upside from the sale of generic Suboxone is expected to be substantial for Dr Reddy's when it resumes sales

According to market reports, suboxone had sales of around $1.86 billion in the US for the 12 months ended April

Stability in American business, new launches key as firm targets to double US portfolio in five years

BS ReporterHyderabad, 16 March: Dr Reddy's Laboratories Limited announced today that it has launched Levocetrizine Dihydrochloride tablets, an over-the counter(OTC) therapeutic equivalent generic version of Xyzal Allergy tablets in the US market as approved by the US Food and Drug Administration(US FDA).The drug is an antihistamine used for 24-hour relief of allergy symptoms such as watery eyes, runny nose, itching eyes and nose and sneezing."This first-to-market launch for the store brand is the testament to the deep capabilities of our store brand OTC business,"said Milan Kalawadia, vice president and head, US OTC and Specialty Rx business at Dr Reddy's Laboratories. "We look forward to collaborating with our customers to bring high-quality, affordable store brand alternatives to the market."The Xyzal Allergy brand had US sales of approximately $ 71 million for the most recent twelve months ending in January 2018, according to the company. Xyzal is a registered trademark of UCB ...

The stock moved higher by 3% to Rs 2,473, extending its Thursday's 3% gain on BSE.

Launch of narcotic treatment drug may be sometime away, but it enhances earnings visibility

Even as not much was expected from Dr Reddy's March quarter results, the higher than estimated decline in profitability was a disappointment. With US FDA related issues remaining unresolved, the near-term outlook continues to be subdued. Revenues at Rs 3,554 crore for March quarter were down five per cent year-on-year, and came lower than Rs 3,683 crore estimated by analysts polled by Bloomberg. This was the fifth consecutive quarterly decline on a year-on-year basis, in revenues. Earnings before interest, tax, depreciation and amortisation (Ebitda) at Rs 630.3 crore was short by a bigger margin as compared to expectations of Rs 779 crore. Consequently, net profit at Rs 312.5 crore was significantly lower than estimates of Rs 385 crore. The major pressure point continues to be US sales. With the company's three Indian facilities under US FDA's warning letter, approvals for new product launches have been delayed thereby impacting the company's growth. Since US generic sales contribute .

USFDA recently issued Form 483 with two observations to DRL's another API facility at Srikakulam

BS ReporterHyderabad, 27 March: Dr Reddy's Laboratories Limited and global medical technology company Integra LifeScinces Holdings Corporation announced today that they have entered into an exclusive distribution agreement under which the Hyderabad-based generic pharma major will market and distribute DuraGen Plus and Suturable DurgaGen dural regeneration matrices for use in patients in India.M V Ramana, executive vice president and head of emerging markets and India business at Dr Reddy's said,"We are delighted to partner with Integra LifeSciences. With the launch of DuraGen, we look forward to building our presence in the segment of regenerative technologies and making a difference to the lives of patients undergoing neurosurgery."Commenting on the tie-up, Integra LifeSciences chief financial officer Glenn Coleman stated that this collaboration will allow the company to expand patient access globally and provide innovative regenerative technology solutions to neurosurgeons and ...

Consolidated net profit was down 80% at Rs 126.3 core for the June quarter