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USFDA NOTICE
US drug regulator resumes surprise inspections in India"In terms of (inspection) activity (in India) we are getting closer to pre-pandemic levels," Sarah McMullen, country director - India at US...20 Sep, 2022, 12.37 AM IST- Patanjali says in “complete compliance of laws”; denies receiving notice from USFDAMedia reports earlier this week said labels on Patanjali's two sharbat products, earmarked to be sold within India, were found to be having...23 Jul, 2019, 02.23 PM IST
- 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...24 Jan, 2017, 01.59 AM IST
- Sun Pharma shares set to extend losses for fourth day on rising concern over Halol facilityETNow on Tuesday reported that the USFDA has informed that the Halol facility has issued a 14-page Form 483 post inspection.07 Dec, 2016, 12.31 PM IST
- USFDA issues warning letter to ex-Sun Pharma US facilityThe Philadelphia plant is among the two facilities that Sun Pharma had sold to Frontida BioPharm in June this year, along with 15 products,...26 Aug, 2016, 06.31 PM IST
- Strides Arcolabs shares fall as Mylan seeks explanation on Agila plantMylan has sent a notice to Strides Arcolabs, seeking explanation over the Agila manufacturing plant and a possible compensation sought by t...15 Dec, 2015, 03.00 AM IST
- USFDA says lead in Maggi within acceptable levelsThe US health regulator USFDA has said its tests have found the lead level in the popular instant food within acceptable levels.12 Aug, 2015, 11.57 AM IST
- Indian Pharma: Regaining our brand equityThe perception that India-made drugs are of “bad quality” is largely due to many related and unrelated convergence of events.08 Apr, 2014, 06.08 AM IST
- Drugs sold by company in the Indian market are safe: RanbaxyRanbaxy insisted drugs sold by it in the Indian market are safe and effective and the company complies with country's regulations.15 Mar, 2014, 05.09 AM IST
- Sun Pharma says issues with USFDA at Caraco facility addressedUnited States Food and Drug Administration had conducted inspections in January and May this year and had noticed the lapses.28 Oct, 2013, 02.59 PM IST
- USFDA finds company's SEZ Indore unit acceptable: Ipca LabsThis will enable the company to commercialise oral solid dosage formulations in the US market from this manufacturing facility.04 Sep, 2013, 02.07 PM IST
- Sun Pharma takes Novartis to US Court, seeks permission to market Glivec in USUntil and unless Sun obtains a court decision of non-infringement and/or invalidity on the ’051 patent, it faces the risk of patent infring...13 Jun, 2013, 04.10 AM IST
- Tighter FDA rules sour local drug cos' American dreamRevenue loss, margin squeeze and frequent audits are increasingly becoming a part of the parcel for drug makers. Top 10 Drugmakers by sale06 Apr, 2010, 04.27 AM IST
- FDA-approved inspectors plan short-notice audit of trialsUnder the scheme, a team of drug inspectors will walk into clinical trial centres at short notice and audit the internal processes and the ...23 May, 2009, 12.57 AM IST
- Sun Pharma shares fall on USFDA notice to CaracoSun Pharmaceutical shares dropped after the US Food and Drug Administration issued a warning to its Detroit-based generic subsidiary, Carac...04 Nov, 2008, 11.02 AM IST
- CROs must play by the bookClinical research organisations (CROs) not adhering to best practices and ethics may now have to deal with stronger regulatory oversight.23 Oct, 2008, 02.31 AM IST
- USFDA plans to set up offices in IndiaWith a view to make inspection of drug production in a more efficient manner, American health regulator US Food and Drug Administration is ...20 Jul, 2008, 10.59 AM IST
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