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FDA COMPLIANCE
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...29 May, 2026, 12.30 PM IST- Tata Elxsi unveils AnaTel, an AI-powered platform for healthcare software engineering and regulatory complianceTata Elxsi’s AnaTel reflects the growing shift toward AI-native healthcare software engineering, bringing AI-driven automation into regulat...28 May, 2026, 04.14 PM IST
- Sentiment is broken, fundamentals are not. PL Asset Management CIO says now is the time to buyIndian equity investors, frustrated by stagnant returns, are urged by Sandeep Neema of PL Asset Management to distinguish weak sentiment fr...25 May, 2026, 09.00 AM IST
- Pregabalin moved to Schedule H1 as centre cracks down on drug misusePregabalin, a nerve pain medication, now faces stricter controls. The Union health ministry has moved it to Schedule H1. This change aims t...22 May, 2026, 12.07 PM IST
- 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.01 May, 2026, 11.26 AM IST
- US Stocks: ImmunityBio shares drop 20% on FDA warning letter over cancer therapy claims in adShares of ImmunityBio fell 20% on Tuesday after the U.S. Food and Drug Administration issued a warning letter that said a television advert...24 Mar, 2026, 08.29 PM IST
- Biocon's Bengaluru drug manufacturing facility gets 'Voluntary Action Indicated' classificationBiocon Biologics' drug substance facility in Bengaluru has been classified as Voluntary Action Indicated (VAI) by the USFDA. This classific...27 Nov, 2025, 08.40 AM IST
- US FDA restricts imports of some Viatris drugs made at India facilityViatris has revealed that the FDA has restricted imports of 11 products made at its Indian facility after an inspection found violations of...23 Dec, 2024, 08.19 PM IST
- 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...25 Jun, 2024, 07.44 AM IST
- To prevent corporate frauds, more needs to be done: EY surveyMany senior executives feel that more needs to be done, such as increasing the use of forensic tools, to detect as well as prevent frauds a...10 Feb, 2022, 03.30 PM IST
- 'Dead lizard' found in food at Haldiram's, FDA shuts down the outletThe incident took place at the outlet located at Ajani square on Tuesday morning.16 May, 2019, 11.08 AM IST
- Pharma cos have not worked on compliance issues: Amit Rajan, Prosfora TechConcern remains over Indian pharma’s sterile manufacturing practices, says Prosfora Tech MD18 Mar, 2019, 02.31 PM IST
- FDA norms punch a Rs 5,000 crore hole in Pharma IndustryIn FY16, the top five — Sun Pharma, Dr Reddy’s, Lupin, Aurobindo and Cipla — ran up a total bill of Rs 3,497 crore in legal and professiona...15 Sep, 2016, 09.29 AM IST
- FSSAI-approved lab finds Maggi noodles safeFSSAI-approved laboratory of Central Food Technological Research Institute has found Maggi noodles to be in compliance with the food safety...05 Aug, 2015, 02.20 AM IST
- US plans tough norms for food imports from India, other placesIndia is 7th largest food exporter to the US and also figures among the top countries in terms of import refusal of food products by the FD...05 Aug, 2013, 01.28 AM IST
- 'Pharma not the best sector to bet on amidst US FDA compliance issues'"The reality at present is that the pharma stocks are always subject to problems with US FDA regulations," says Sajiv Dhawan of JV Capital.13 Apr, 2011, 03.12 PM IST
- 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.18 Mar, 2009, 04.15 PM IST
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