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USFDA NOTICE
India bans 16 fixed-dose drug combinations over safety concernsIn a significant public health initiative, the ban on 16 fixed-dose drug combinations, including various antibiotics and topical formulatio...- Zydus Lifesciences shares in focus after 2 regulatory approvals from Health Canada, USFDAZydus Life shares: Zydus Lifesciences received regulatory approvals from Health Canada for generic Liothyronine tablets and from the USFDA ...
- USFDA issues Form 483 with 5 procedural observations to Torrent Pharma's Gujarat unitTorrent Pharmaceuticals said Tuesday that the US health regulator has given them a Form 483 with five procedural comments after inspecting ...
- 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...
- 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...
- 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...
- 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.
- 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,...
- 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...
- 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.
- 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.
- 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.
- 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.
- 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.
- 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...
- 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 sale
- 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 ...
- 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...
- 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.
- 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 ...
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