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FDA INSPECTION
More macro headwinds on the cards? Tackle them with core principles: 6 pharma stocks with upside potential of up to 28%There was a time when the Indian pharma story in the US was almost entirely about inspection risk. The US FDA would inspect a plant, a warn...- U.S. drug regulator flags data integrity, maintenance lapses at Dabur India plantThe U.S. FDA has identified significant data integrity and manufacturing lapses at a Dabur India plant following a January inspection. Find...
- Multiple items recalled at Walmart, ALDI including frozen pizza and pork rinds amid salmonella concerns - Check the contaminated ingredient and full list of productsA nationwide recall has been issued for at least eight products sold at ALDI and Walmart , including frozen pizzas and pork rinds, due to p...
- Compliance squeeze, global scrutiny redefine India’s $30 billion pharma export playbookAs global markets prioritise quality and regulatory trust, India’s pharma sector is recalibrating beyond its traditional cost advantage.
- India-New Zealand FTA to be signed on Monday, says PM Christopher LuxonIndia and New Zealand will sign a Free Trade Agreement on Monday, April 27. This landmark deal aims to boost bilateral trade significantly....
- No 'zombie drug', man seen in Thane video overdosed on pain medicine: PoliceThane police have clarified a viral video showing a disoriented man. The man was not under the influence of a 'zombie drug'. He had taken a...
- Egg Float Test, Explained: The Simple Bowl of Water Trick To Check Freshness And When To Toss ItThe egg float test, a simple kitchen method, indicates an egg's age by measuring its density, which changes as air enters the shell over ti...
- Dinosaur Chicken Nuggets recall: Lead contamination may puts your kids at risk – here's what Walmart shoppers should do to stay safeDinosaur chicken nuggets recall: A routine food safety check has led to a recall of Great Value Dino Nuggets sold at Walmart due to potenti...
- Did Ozempic manufacturer Novo Nordisk hide drug death reports? Here’s what FDA said about side-effect reportingDespite ongoing debate, medications such as Ozempic continue to rank among the most commonly prescribed treatments for weight management an...
- US Senator raises alarm over poor-quality drug imports from India and China, seeks tougher FDA inspectionsIn a letter to FDA Commissioner Martin Makary, Banks said the agency must "do more to protect the US drug supply," warning that lax oversig...
- USFDA issues Form 483 with 8 observations to Aurobindo's Telangana unitAurobindo Pharma faces scrutiny. The US FDA inspected its Bachupally, Telangana plant. The inspection occurred between August 25 and Septem...
- US lawmakers questions FDAs drug inspection programme in India and ChinaThree top American lawmakers have raised concerns about the FDA's foreign drug inspection program in India and China. In a letter to FDA Co...
- US FDA inspects Vishakhapatnam facility of Solara Active PharmaThe US Food and Drug Administration (FDA) completes inspection of Solara Active Pharma Sciences' API manufacturing facility in Visakhapatna...
- Understanding US FDA inspection: How investors and management can avoid heartburnWith India playing a significant role in the global pharmaceutical sector, one may wonder about the quality control practices adopted in th...
- Indian drugmaker to pay $50mn in fine for destroying records before FDA inspectionIn a criminal information filed in federal court in the District of Nevada and unsealed on Tuesday, Fresenius Kabi Oncology Limited (FKOL) ...
- Injectable units under cloud as India lacks experts in aseptic practices: Amit Rajan, Prosfora TechIndian pharma cos putting up ANDAs and APIs in one plant to avoid paying GDUFA fee, says Rajan.
- Data on US FDA observations on Indian firms disturbing: EdelweissSince the Generic Drug User Fee Amendments implementation in Oct 2012, FDA inspections have doubled in India and China, which led to consid...
- USFDA notice to Hetero over conditions at Telangana unitThe 13-page observation by investigators Massoud Motamed and Latorie Jones noted several deviations that were against good manufacturing pr...
- USFDA to increase its India headcount"USFDA is in the process of taking the headcount up to 19. We have offices in New Delhi and Mumbai. Currently we have 9 or 10 (officials wo...
- Strides Acrolab receives US FDA approvalThe Rs 1000 crore generic pharma company has received US FDA inspection approval status for its steriles injectable complex at Bangalore.
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