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FDA COMPLIANCE ISSUES
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...- 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...
- 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...
- 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.
- 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...
- 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...
- 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...
- Lupin gets warning letter from FDA for Tarapur facility, stock falls over 2%“We wish to inform you that the company has received a warning letter from the US FDA for the company’s Tarapur, Maharashtra facility. The ...
- US FDA issues warning letter to Lupin's Tarapur unitThe United States Food and Drug Administration (US FDA) has issued a warning letter to Lupin's Tarapur, Maharashtra facility, the company s...
- US FDA issues seven observations on Sun Pharma's Mohali siteThe FDA said there was no password protection and noted, "Laboratory analysts have the ability to change instrument settings including date...
- Drug regulators urge pharma companies to clean upBuilding a strong quality culture, adapting quality metrics and demystifying data reliability issues were broad themes at Indian Pharmaceut...
- IPCA Lab tanks on USFDA import alert; m-cap down by Rs 1,205 croreDuring the day the shares of the company opened on a weak note and then tanked as much as 13.42% to touch an intra-day low of Rs 658 on the...
- 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 ...
- US FDA cites Apotex's Indian drug facility for fraudulent dataAn Indian subsidiary of Apotex manipulated laboratory data, retesting samples until the results were acceptable, according to a warning let...
- Jubilant Life Sciences plunges 10% on USFDA warning letterJubilant Life Sciences was witnessing selling pressure after one of its manufacturing facilities in the US, was issued a warning letter (WL...
- US cracks down on websites selling bidis, Indian cigarettesFDA said that their several products have been found to be "adulterated" under relevant regulations and did not carry the required permits ...
- '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.
- Pharma cos to get less time to correct manufacturing flawsIndia has the highest number of FDA-approved drug plants outside the US, making it one of the largest suppliers to the world’s top pharma m...
- 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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