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US FDA INSPECTION
Why CDSCO and BEE have not kept pace with the industries they overseeCDSCO still faces challenges like chronic understaffing, gaps in technical skills, weak lab infra and fragmented approvals. About a decade ...- 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...
- 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 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...
- Aurobindo's Andhra plant receives 1 observation from USFDA after inspectionAurobindo Pharma has received a Form 483 with one observation from the US FDA after an inspection of its formulation production facility in...
- 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 pharma compliance standards improving, regulatory risks here to stay: Ind-RaAs Indian pharma accounts a significant share of the US generic market, Ind-Ra said it has seen increased scrutiny of the manufacturing fac...
- 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...
- Sun Pharma's Mohali manufacturing site being inspected by US FDA: SourcesThe US drug regulator had imposed an import alert on the facility following issues related to manufacturing violations.
- US FDA issues import alert to 2 plants of IPCA LaboratoriesThe U.S. regulator had in January banned imports from a separate central Indian manufacturing plant of Ipca, citing violations of standard ...
- 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...
- US FDA inspects Lupin's new plant in IndoreThe US drug regulator has started inspection of Indian drugmaker Lupin’s upcoming plant at Indore last week, a person close to the developm...
- 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.
- Lupin’s MP plant under USFDA scannerThe US Food and Drug Administration (USFDA) has found 15 manufacturing deficiencies at one of Lupin’s plant in Madhya Pradesh (MP) during t...
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