Page 3 - Dr Reddy's Laboratories Limited

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 earnings future uncertain beyond FY27, say analysts; stock up 3%

Indian pharmaceutical major, Dr Reddy's Laboratories share surged 3.1 per cent at Rs 1,312 a piece on the BSE in Wednesday's intraday deals

Dr Reddy's recalls over 330k bottles of generic drug in US: USFDA

Dr Reddy's Laboratories is recalling over 3.3 lakh bottles of a medication used to treat high calcium levels in the blood and hyperparathyroidism in the US market due to manufacturing issues. According to the latest Enforcement Report by the US Food and Drug Administration, Dr Reddy's is recalling the 3,31,590 bottles of Cinacalcet tablets in multiple strengths in the American market due to CGMP (current good manufacturing practice) deviations. The recall is due to the "presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit", it added. New Jersey-based Dr Reddy's Laboratories, Inc., a unit of Hyderabad-based drug major, is recalling 2,85,126 bottles of Cinacalcet tablets in 30 mg strength. Besides, the drug maker is recalling 35,880 and 10,584 bottles of 60 mg and 90 mg strengths, respectively, USFDA said. The affected lot has been produced in India, it added. US-based Dr Reddy's Laboratories, Inc. initiated the Class II nationwide (US) recall on October 9

Buy or Sell? TCS, Maruti, HUL among 7 Nifty stocks trading in oversold zone

These 7 Nifty 50 stocks are seen trading with an RSI below 30; stocks trading in oversold zone need not necessarily bounce back immediately. Here are the key levels to watch out for.

Dr Reddy's, Hetero sign voluntary licenses with Gilead for HIV drug

Gilead Sciences first launched lenacapavir under the brand name Sunlenca in the United States and European markets in 2022. It is a first-in-class HIV-1 capsid inhibitor

UBS fears slowdown in India, US pharma markets; gives 'Sell' on 4 stocks

As per UBS, the Indian pharma market is slowing down due to a sharp increase in unbranded generics

Congress vs Sebi chief Buch: Trading strategies in M&M, Pidilite, Wockhardt

After ICICI and Wockhardt; M&M, Dr.Reddy's and Pidilite are the latest company names to be dragged in the Congress versus Sebi chief controversy. Here's a technical outlook on these stocks.

Dr Reddy's declines 3% after China's regulator bans import of ADHD drug

Atomoxetine is used for treating attention deficit hyperactivity disorder (ADHD) in adults and children over six years.

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

Dr Reddy's Laboratories Q1 result: Net profit dips 0.90%, revenue up 13.88%

DRL's growth was primarily driven by the robust performance of the global generics business, particularly in North America and India

Stocks to Watch, July 24: HUL, Bajaj Fin, L&T, Dr Reddy's, Vedanta, Axis Bk

Stocks to Watch today, Wednesday, July 24, 2024: HUL reported a 2.2 per cent Y-o-Y rise in consolidated net profit at Rs 2,610 crore for Q1FY25, in line with market expectations

Stocks to watch, July 19: Infosys, RIL, Vi, LTTS, Tata Consumer, DRL, CEAT

At 6:36 AM, GIFT Nifty futures were up 19 points, trading at 24,828.50 levels, indicating a higher start for the day.

Dr Reddy's Laboratories, Warburg Pincus, EQT frontrunners to buy BSV

Advent looking to exit 4 years after it picked up majority stake in biopharma firm

Sun Pharma, Dr Reddy's pull drugs in US over manufacturing issues: USFDA

Sun Pharma and Dr Reddy's Laboratories are recalling products in the American market due to manufacturing issues, the US Food and Drug Administration (USFDA) has said. In its latest Enforcement Report, the US health regulator stated that a US-based unit of Sun Pharma is recalling 35,069 bottles of medication used to treat high pressure inside the eye due to glaucoma or other eye diseases. New Jersey-based Sun Pharmaceutical Industries Inc is recalling the affected lot of Xelpros (latanoprost ophthalmic emulsion) due to "out of specification for particulate matter test". The company initiated the voluntary Class III recall in the US on April 22 this year, the USFDA stated. In a separate filing, the USFDA stated that a US-based arm of Dr Reddy's Laboratories is recalling 1,176 bottles of an immunosuppressant medication. Dr Reddy's Laboratories Inc is recalling the affected lot of Sirolimus Tablets due to "Failed Impurities/Degradation Specifications", the USFDA said. The company ...

Drug makers Dr Reddy's, Sun Pharma, Aurobindo recall products in US market

Drug makers Dr Reddy's Laboratories, Sun Pharma and Aurobindo Pharma are recalling products in the US market due to manufacturing issues, as per the latest Enforcement Report of the US Food and Drug Administration (USFDA). Dr Reddy's Laboratories is recalling close to 20,000 cartons of a medication used to control blood phenylalanine levels in adults and children. Princeton (New Jersey) based Dr Reddy's Laboratories, Inc, is recalling Javygtor (sapropterin dihydrochloride) Powder for Oral Solution (100mg) due to it being a "Sub-potent Drug", USFDA stated. The company is also recalling another lot of sapropterin dihydrochloride for the same reason, it added. The USFDA said the drug maker initiated the Class I recall in the US on April 8 this year. As per the US health regulator, a Class I recall pertains to defective products that can cause serious health problems. The USFDA said Sun Pharma is recalling 11,016 vials of Amphotericin B Liposome for Injection, used to treat fungal ...

Dr Reddy's, Bayer partner to market second brand of Vericiguat in India

Vericiguat is currently approved for use in 35 countries

Dr Reddy's partners with Sanofi India to distribute vaccine brands in India

Under the terms of this agreement, Dr Reddy's will have exclusive rights to promote and distribute Sanofi's vaccine brands, including Hexaxim, Pentaxim, Tetraxim, Menactra, FluQuadri and Adacel

Dr Reddy's Laboratories R&D facility gets VAI status in USFDA inspection

Last year in December, during the Good Manufacturing Practice (GMP) and Pre-Approval Inspection at the same facility concluded with three observations

Dr Reddy's Laboratories acquires women's health brands from MenoLabs

DRL said that it has acquired the entire MenoLabs supplements portfolio, which includes seven branded products designed to provide health support and address symptoms of perimenopause and menopause

DRL partners with Coya Therapeutics to develop nerve disorder therapy

Amyotrophic Lateral Sclerosis (ALS) is a fatal neurological disorder characterised by progressive degeneration of nerve cells in the spinal cord and brain