Eugia Steriles' new injectables facility in Andhra receives its first product approval by FDAAurobindo Pharma Ltd announced that its subsidiary, Eugia Steriles Private Limited, received its first product approval from the US FDA for...
11 Sep, 2024, 02.34 PM IST
FDA issues Warning Letter to Mylan Laboratories Limited's Telangana plantThe US drug regulator in a letter on September 1 told the drug-maker that the FDA investigators found lapses in the plant as there were no ...
03 Sep, 2020, 11.57 AM IST
Jubilant Life slips 4% on USFDA inspectionThis will not have any impact on the existing revenues from operations from this facility, the company said.
10 Dec, 2018, 03.51 PM IST
USFDA recommends regulatory action after Jubilant Life's Roorkee plant inspectionAccording to the FDA, Official Action Indicated means regulatory and/or administrative actions will be recommended against a facility after...
08 Dec, 2018, 04.47 PM IST
‘Banned ingredients in diet pills putting Indians at risk’Several dietary supplements, most of which are widely available in India, have been found adulterated with unapproved and even banned pharm...
27 Oct, 2018, 12.07 PM IST
Soon, tiny chips may replace animal testingThe flexible polymer organ-chips contain tiny channels lined with living human cells and are capable of reproducing blood and air flow just...
17 Apr, 2017, 05.47 PM IST
USFDA issues warning letter to USV Pvt over Daman plantThe warning letter to Managing Director Prashant K Tewari raised similar current good manufacturing practice (CGMP) violations at its other...
23 Mar, 2017, 04.52 PM IST
USFDA issues warning letter to Megafine Pharma for Vapi plantSummarising significant deviations from CGMP norms at the Vapi unit, the US Food and Drug Administration said that its investigators observ...
08 Mar, 2017, 08.57 PM IST
USFDA issues warning letter to Emcure PharmaceuticalsThe US Food and Drug Administration (USFDA) has issued a warning letter to Emcure Pharmaceuticals for violating current good manufacturing ...
16 Mar, 2016, 09.01 PM IST
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...
18 Jun, 2014, 04.40 PM IST
US generic drug fee relief plan may benefit Indian companiesAmerican health regulator FDA could consider bringing some relief in payment of fees to small generic drug makers, including those from Ind...
15 Dec, 2013, 12.38 PM IST
Indian companies among firms yet to pay annual facility fees to FDAFDA has named at least five Indian companies among 43 drugmakers that have failed to meet their annual facility fee payment obligations.
06 Sep, 2013, 04.15 PM IST
US to hike fees for generic drugmakers; Indian firms to be hitUS health regulator FDA is hiking the fees for generic drugmakers by up to 48 per cent from October, that will hit Indian drugmakers.
11 Aug, 2013, 05.27 PM 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
US clamps down on sale of 'natural' diabetes drugs from IndiaUS health regulator FDA has initiated action against 15 companies for supply of illegal sale of India-originating drugs.
25 Jul, 2013, 05.09 PM IST
US drug regulator issues warning letter to RPG Life SciencesUSFDA has issued a warning letter to RPG Life Sciences for violation of current good manufacturing practice (CGMP) norms at its two plants ...
19 Jun, 2013, 08.40 PM IST
NRI’s energy drink under lens for 13 deaths in USLucknow-born Manoj Bhargava, whose "5-hour Energy" drink has a cult following in the US, is at the centre of FDA filings.
17 Nov, 2012, 11.40 AM IST