Optimising costs to beat price erosion in US market: Alembic PharmaceuticalsIn an interview to ET, Pranav Amin, Managing Director of Alembic Pharmaceuticals said the management still remains bullish on the US market...
11 Nov, 2021, 07.15 PM IST
Alembic Q2 net profit falls 49% to Rs 169 crore; gets observations from USFDA for Karkhadi facilityThe company had posted a net profit of Rs 333.37 crore for the corresponding period of the previous fiscal, Alembic Pharmaceuticals said in...
10 Nov, 2021, 05.25 PM IST
US FDA finds quality control, equipment issues at Alembic Pharma unitEarlier this month, the US drug regulator had issued a ‘Form 483’ to the facility of the drug company with five observations.
19 Feb, 2021, 03.56 PM IST
Alembic Pharma gets five observations from USFDA for Gujarat facilityAs per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when an investigator has observed any cond...
08 Feb, 2021, 12.15 PM IST
USFDA inspects Alembic Pharma's facility in Karkhadi, GujaratUSFDA issued a form 483 with two observations, the drug firm said in a filing to BSE.
21 Jan, 2020, 03.46 PM IST
Don’t worry about FDA, time to buy pharmaCadila Healthcare is an example of how a supposedly severe FDA clamp could also translate into an opportunity to accumulate the stock.
12 Oct, 2016, 08.36 AM IST
Sun Pharma shares a good buy despite short-term painStock may see a sell-off on earnings downgrades & FDA warning, but co has not revised revenue guidance & FIs have steadily raised holdings.
21 Dec, 2015, 09.47 AM IST
India wants its officials during USFDA inspections at drug unitsIn many cases, these companies have been barred from selling their drugs in the US and other countries, although Indian firms account for a...
11 Jan, 2015, 12.19 PM IST
Most pharma companies earn USFDA wrath over data integrity issuesThe US is the largest market for domestic generic companies, contributing 25-55% of revenues for large companies, while India supplies arou...
29 Dec, 2014, 01.27 PM IST
USFDA raps Sun Pharmaceuticals for delay in follow-up for recalled drugs from US marketThe inspectors chided the firm for not documenting alarm events that occur during the routine tablet compression, among other observations.
11 Oct, 2014, 04.15 AM 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 penal actions hit pharma exports growth, may not exceed 5%Analysts expect that the problems of Indian generic manufacturers could only go up as the foreign inspections of FDA will only rise.
17 Apr, 2014, 03.17 AM IST
USFDA cites torn records, unclean toilets for banning Sun Pharma's Gujarat plantAnalysts had pointed out that the import alert by the US Food and Drug Administration on the facility was unlikely to cause any significant...
03 Apr, 2014, 04.00 AM IST
India ready to discuss intellectual property rights norms at WTO if US wants: Anand SharmaRejecting US allegations related to intellectual property rights, India said that it is ready to discuss the matter at WTO as it has not br...
23 Mar, 2014, 11.54 AM IST
Sun Pharma tanks nearly 9% in two sessions on USFDA import alertShares of Sun Pharma continued to remain under pressure for second straight session after the USFDA issued an Import Alert to its plant.
14 Mar, 2014, 10.27 AM IST
Now,USFDA's import alert on Sun Pharma's Karkhadi plant in GujaratFacilities of leading Indian drugmakers including Ranbaxy and Wockhardt were blacklisted by the US regulator last year.
14 Mar, 2014, 02.30 AM IST
Sun Pharmaceutical Industries shares dive over 5% on USFDA import banShares of Sun Pharmaceutical Industries today fell by over 5 per cent after the US Food and Drug Administration banned import of drugs from...
13 Mar, 2014, 06.04 PM IST