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S FDA INSPECTION
Punjab drug body finds critical lapses at Jackson Laboratories' manufacturing facility in AmritsarThe Punjab FDA has taken decisive action by revoking the manufacturing licence of Jackson Laboratories in Amritsar due to severe regulatory...
Maharashtra FDA bans serving food in newspapers, issues statewide food safety orderMaharashtra FDA has launched 'Safe Food, Healthy Maharashtra' banning food served on newspapers and enforcing strict hygiene. Hotels, resta...
Plan in the works to let hospitals import med equipment directlyIndia's drug regulator is proposing to allow hospitals to directly import advanced medical equipment like MRI and CT scanners, bypassing cu...
USFDA concludes inspection at Jubilant HollisterStier's Spokane plant with 8 observationsJubilant Pharmova announced its US subsidiary, Jubilant HollisterStier LLC, underwent a USFDA inspection. The facility in Spokane, Washingt...
Maharashtra FDA bars hospitals from forcing patients to buy medicines in-houseMaharashtra's Food and Drug Administration has issued a significant directive. Hospitals and medical practitioners must now allow patients ...
Dabur India shares in focus after US FDA places drugs from Silvassa plant under import alert. Here’s whyDabur India shares are set to be in focus after the US FDA issued an import alert on drugs manufactured at its Silvassa plant, citing data ...
US drug regulator issues import alert for drugs made at a Dabur India plantThe US Food and Drug Administration has placed Dabur India's factory on an import alert. This action follows an inspection that revealed si...
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...
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...
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...