Aurobindo may take its injectable unit publicAurobindo Pharma is revisiting plans to sell a strategic stake in its injectable unit, Eugia Pharma Specialities, focusing on an IPO. Previ...
14 Aug, 2024, 11.10 PM IST
US-based Zeda plans to raise up to $200 million for India forayUS-based Zeda Holdings plans to raise $200 million for its India expansion, led by CEO Shri Shetty. The company uses 3D printing for orthop...
03 Jun, 2024, 12.57 AM IST
Glenmark gets USFDA nod to begin trials for potential cancer drugThe USFDA approval paves the way for Glenmark's subsidiary Glenmark Specialty to proceed with a Phase 1/2, first-in-human, clinical study o...
16 Mar, 2023, 06.24 PM IST
USFDA chief supports generics made in IndiaThe Indian drug makers are finally seeing a recovery with most of their factories being cleared by the US watchdog.
26 Feb, 2019, 08.16 AM IST
Beaten-down pharma stocks hope for boost from new USFDA chiefScott Gottlieb is known to favour quicker entry of generic drugs in the market.
27 Jun, 2017, 12.03 PM IST
USFDA glare, high valuations trigger correction in pharma stocksWhile the broad-based Nifty Pharma index is down 12.4% from November 4 till date, the loss has been more pronounced in individual stocks.
11 Nov, 2015, 07.08 AM IST
Dr Reddy's says new drug approvals will be delayedThe warning letter issued by the US Food and Drug Administration will impact Dr Reddy's new drug approvals, the company said.
09 Nov, 2015, 06.19 PM IST
Cipla gets USFDA nod for Lopinavir, Ritonavir oral pelletsCipla has received approval from US health regulator USFDA for Lopinavir and Ritonavir oral pellets used for treating AIDS in infants and y...
03 Jun, 2015, 06.01 PM IST
Sun Pharmaceutical's woes deepen as US arm Taro recalls Warfarin from marketsThis is the third such recall for Sun which agreed to buy troubled fellow drug maker Ranbaxy in March this year to create the world's fifth...
12 Sep, 2014, 01.16 AM 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
India criticizes US whistleblower policy; says it may lead to policy abuse by sore staffIndia has called for a review of the US whistleblower policy as it feels generous incentives offered by USFDA may lead to policy abuse by s...
06 Mar, 2014, 04.00 AM IST
Lapses by few drugmakers clouded good manufacturing practices by others: USFDA chiefThe US drug regulator has in 2013 hauled up leading India-based firms like Ranbaxy for failure to comply with good manufacturing practices.
13 Feb, 2014, 06.21 AM IST
USFDA to hold workshops across India on quality requirementsUSFDA plans to conduct workshops across India in the next one year in order to sanitise Indian drug cos about the changing quality requirem...
11 Feb, 2014, 08.51 PM IST
India wants USFDA chief to treat clinical volunteers on par with US counterpartsIndia's drug regulator may urge USFDA chief to ensure that drugmakers from US conducting clinical trials treat the volunteers on internatio...
06 Feb, 2014, 04.00 AM IST
Ranbaxy sets aside Rs 257.4 crore for impact of USFDA banRanbaxy Laboratories has set aside Rs 257.4 crore towards the financial impact of a US ban on import of products made at its plant at Toans...
05 Feb, 2014, 06.43 PM IST
- Strides Arcolab's Polish sterile facility gets USFDA nod
Strides Arcolab today said its injectables unit Agila Specialties has received US Food and Drug Administration (USFDA) approval for its Pol...
13 Sep, 2012, 05.21 PM IST
- Issues with USFDA to take long to resolve: Ranbaxy
Ranbaxy is in talks with the US Food and Drug Administration (USFDA)to sort out issues related to generic drugs but the matter is likely to...
09 Nov, 2009, 11.31 AM IST