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U.S. FDA INSPECTION
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...
- 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...
- 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....
- 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...
- Sun Pharma shares in focus after USFDA flags ‘official action indicated’ status for Halol facilitySun Pharma shares: The company revealed that the FDA classified its Halol facility as “Official Action Indicated” after finding CGMP violat...
- Glenmark Pharma shares in focus after USFDA warning to Indore plantGlenmark Pharmaceuticals disclosed receiving a warning letter from the U.S. FDA for its Indore facility following a February inspection. Th...
- Orchid Pharma shares in focus as U.S. FDA completes facility inspectionOrchid Pharma share price: Orchid Pharma's Alathur facility is the only U.S. FDA-approved manufacturing site in India for sterile cephalosp...
- Lupin shares in focus as USFDA inspection at Somerset facility concludes with no observationsEarlier in January, the company received the Establishment Inspection Report (EIR) from USFDA for its Pithampur Unit-1 manufacturing facili...
- US food regulator gathering information on Indian spices after alleged contamination in MDH and EverestThe US FDA is investigating Indian spice makers MDH and Everest after Hong Kong and Singapore halted sales of their products due to alleged...
- US lawmaker seeks answers on FDA inspection of Musk's NeuralinkNeuralink, which first tested its device in monkeys and other animals, is now testing the device in humans. The company makes a brain-chip ...
- US FDA to boost inspections of drug manufacturing units in IndiaThe FDA plans to increase inspections at Indian drug manufacturing units in 2024. They conducted over 200 inspections in 2023. The Indian p...
- 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...
- 15 million doses discarded: The company at the heart of J&J vaccine row had history of violationsJ&J locked arms with Emergent in April 2020, enlisting the lesser-known company to manufacture its vaccine. At the time, Emergent's Bayview...
- Bayer's chloroquine donation to U.S. raises concern about FDA standards in pandemicOn Mar 21, two days after President Trump first touted chloroquine drugs as a "gamechanger" in the fight against COVID-19, administration o...
- US to broaden scrutiny of drug facilities in China, IndiaFaced with the globalization of drug production, the United States is joining with Europe and Australia to inspect factories in countries l...
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