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FDA recalls Friendly’s and Blue Bell ice cream over undeclared allergens: What you need to know
The US FDA has urgently recalled two popular ice cream brands across multiple states due packaging mistakes and hidden allergens
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Is orange juice too sweet for your health? US FDA plans to cut sugar as experts urge caution
From 24g per glass to 17g? Experts say that even natural sugars in juice should be consumed with caution—and recommend choosing fruit over juice wherever possible.
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Stocks To Watch: Alembic Pharma, BHEL, Zydus Life, Wipro In Focus | February 17
In today's stock market update for February 17, we highlight key stocks to watch: Wipro, which appointed Amit Kumar as Managing Partner and Global Head of Consulting; BHEL, which secured a Letter of Intent for a thermal power project; and Alembic Pharma, which received a Voluntary Action Indicated classification from the US FDA for its Jarod facility. Zydus Lifesciences passed a successful US FDA inspection with no observations at its Ambernath site. Meanwhile, Ujjivan Small Finance Bank and Shriram Finance face RBI penalties for non-compliance with loan and KYC regulations. Stay tuned for more market insights!
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Stocks On Radar: Lupin, Hero MotoCorp, Eicher Motors, MOIL In Focus | February 3
Stay ahead of the market with today's top stock updates! Gujarat Gas Chairman Raj Kumar resigns, Lupin clears a key US FDA inspection, and MOIL hikes manganese ore prices. Coal India reports a slight dip in production, while Indian Bank raises lending rates. Get the latest on major deals, earnings, and market trends that could impact your portfolio.
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Dr Reddy's: US FDA issues form 483 with 4 observations for its Andhra facility
Post the observations, Dr Reddy's said that it will address the issues within the stipulated timeline.
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Lupin stock climbs nearly 4% on launch of Mirabegron Extended-Release tablets in US
Mirabegron Extended-Release tablets had estimated annual sales of $1,019 million in the US
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US FDA releases details of OAI observations at Sun Pharma’s Dadra plant
Dadra's specialization lies in the production of oral solid dosage forms and the manufacture of the blockbuster drug Revlimid, a vital revenue driver for Sun Pharma's generics segment.
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US FDA releases details of observations on Alkem's Baddi Plant
The US FDA had conducted an inspection of the facility last month and had made ten procedural observations, including issues with cleanliness and the company's failure to keep written documents on quality control procedures.
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Lupin, Glenmark, Natco recall products from US markets
Lupin recalled 26,352 bottles of Rifampin capsules, used in the treatment of tuberculosis
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US FDA issues 4 observations for Zydus Life's Ahmedabad injectable plant
Earlier on 26 March, Zydus Life's shares surged after the company received tentative approval from the US Food and Drug Administration (FDA) for its Letermovir tablets.
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Neuland Labs zooms 6% on US FDA all clear for Hyderabad facility
the US Food and Drug Administration inspected the firm's Bonthapally facility in Hyderabad from March 18-22
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US FDA makes observation on Lupin's Aurangabad plant
The FDA inspected the Aurangabad facility between March 6 and 15
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US FDA delays Lilly Alzheimer's drug decision, calls for advisory panel
This is the second regulatory delay for the drug, donanemab, after the company released clinical trial data last year that it says showed the treatment to be safe and effective.
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US FDA slaps Aurobindo Pharma's Telangana injectable facility with 7 observations
The company said that these observations are procedural in nature and will be responded to within the stipulated time.
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Pfizer, Glenmark join hands to launch skin disease drug in India
Developed by Pfizer, abrocitinib has received marketing authorisation from the Central Drugs Standard Control Organisation (CDSCO), the companies said in a statement on Wednesday.
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US FDA releases detailed observations at Torrent's Chhatral unit; shares trade high
This was a Pre-Approval inspection conducted from 5 December to 11 December 2023.
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A year of hits and misses for the Indian pharma sector
Even as pharma exports grew in terms of volumes and value, the cloud of inadequate hygiene and safety in some pharma companies continued to hang over the industry, forcing the government to put in place more stringent inspections and processes.
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Aurobindo subsidiary in Tirupati classified as VAI by US FDA
Aurobindo Pharma shares hit their record high of Rs 1,081.95 a piece around 1 pm today, December 20.
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US FDA inspects Dr. Reddy's, Sun Pharma, Torrent Pharma, Laurus Labs plants
According to the report, inspections are happening at Sun Pharma's Dadra Facility, Torrent Pharma’s Oncology Facility, & Laurus Labs’ Vizag Facility.
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US FDA hits Intas Pharma with warning letter; notes data integrity lapses at Ahmedabad plant
The regulator noted that visual inspectors manipulated particle and other defect counts on records to keep the finished product batches within rejection limits
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Glenmark, Sun Pharma recall drugs in the US over labelling and manufacturing concerns, confirms USFDA
Glenmark Pharmaceuticals recalled 37,200 bottles of Indomethacin capsules and Sun Pharma recalled 2016 bottles of buPROPion Hydrochloride Extended-Release Tablets.
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Lupin gets approval from US FDA for Ganirelix Acetate injection
The product will be manufactured at Lupin’s Nagpur facility in India.
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USFDA flags cleanliness, procedural issues at Dr Reddy's Bachupally unit in Hyderabad
Earlier, Dr Reddy's Laboratories Ltd said the USFDA has issued a Form 483 with 10 observations for its biologics manufacturing facility located in Hyderabad's Bachupally.
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IPCA Pithampur unit in minimally acceptable state of compliance by US FDA
IPCA Labs will release its Q2 results on November 10
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Dr. Reddy’s Hyderabad plant handed 10 US FDA observations
This was a routine cGMP inspection at our formulations manufacturing facility (FTO-3) in Hyderabad.
