News for 'FDA'

An Indian American in the White House?

An Indian American in the White House?

Rediff.com13 Mar 2023

What would an Indian American president of the US look like, sound like and act like, especially on issues and policies pertaining to his or her 'mother-land'?, asks N Sathiya Moorthy.

Dr Reddy's sued in US court by S Korean pharma co

Dr Reddy's sued in US court by S Korean pharma co

Rediff.com27 Jan 2017

Suit alleges fraud by hiding significant deficiencies in CGMP regulations enforced by US health regulator.

Sklamberg on challenges the US drug regulator faces globally

Sklamberg on challenges the US drug regulator faces globally

Rediff.com19 Mar 2015

The US Food and Drug Administration (FDA) says it does not follow an India agenda.

US food regulator testing Maggi noodles after India recall

US food regulator testing Maggi noodles after India recall

Rediff.com11 Jun 2015

Nestle, the world's largest food company, is seeking to defend its reputation in India after it pulled Maggi noodles from stores.

FSSAI-approved lab finds Maggi noodles safe

FSSAI-approved lab finds Maggi noodles safe

Rediff.com4 Aug 2015

Many countries found Maggi noodles to be safe for consumption.

Dilip Shangvi down Rs 90,840 crores in two years!

Dilip Shangvi down Rs 90,840 crores in two years!

Rediff.com8 Jun 2017

An end to Sun Pharma founder Dilip Shanghvi's woes are not in sight.

New drug regulator on US FDA lines

New drug regulator on US FDA lines

Rediff.com20 Aug 2005

Ranbaxy gets FDA nod for migraine drug

Ranbaxy gets FDA nod for migraine drug

Rediff.com3 Aug 2005

Ranbaxy Laboratories on Wednesday said it has received USFDA tentative approval for Sumatriptan Succinate tablets.\n\n

India raises concerns over FDA actions on domestic drug firms

India raises concerns over FDA actions on domestic drug firms

Rediff.com10 Feb 2014

India on Monday raised serious concerns over the USFDA's audit inspections of Indian pharma companies and 'disproportionate penalties' in some instances and said it would submit a discussion document on the issues to the US.

Silicone breast implants may rupture: US FDA

Silicone breast implants may rupture: US FDA

Rediff.com8 Apr 2005

The alternative, saline implants, rupture too, but such failures are quickly recognised by women as their breasts deflate.

Anti-malarial drug a 'line of defence' against virus: Trump

Anti-malarial drug a 'line of defence' against virus: Trump

Rediff.com20 May 2020

The US president said the drug has gotten a bad reputation only because 'he was promoting it'.

US regulator not happy with Sun Pharma's reply on import alert

US regulator not happy with Sun Pharma's reply on import alert

Rediff.com21 May 2014

In March, the FDA had issued an import alert, banning formulations and active pharmaceutical ingredients from the factory.

Ranbaxy's diabetes drug gets US FDA nod

Ranbaxy's diabetes drug gets US FDA nod

Rediff.com22 Jun 2004

Ranbaxy on Tuesday announced it had got final approval from the US Food and Drug Administration to market its Metformin HC1 tablets for diabetes.

Ranbaxy gets final FDA nod for drug

Ranbaxy gets final FDA nod for drug

Rediff.com10 Jun 2004

Ranbaxy Laboratories on Thursday said that it had received final approval from US Food and Drug Administration to manufacture and market Ciprofloxacin.

Dr Reddy's get FDA nod for Ciprofloxacin

Dr Reddy's get FDA nod for Ciprofloxacin

Rediff.com10 Jun 2004

Dr Reddy's Laboratories Limited announced on Thursday that the United States Food and Drug Administration has issued final approval for the company's abbreviated New Drug Application for Ciprofloxacin tablets 100 mg, 250 mg, 500 mg and 750 mg.

US eases travel recommendations on India as Covid cases fall

US eases travel recommendations on India as Covid cases fall

Rediff.com20 Jul 2021

When last month's advisory was issued, India was struggling with a second wave of the pandemic with more than 3,00,000 daily new coronavirus cases being reported.

Ranbaxy gets FDA nod for hypertension drug

Ranbaxy gets FDA nod for hypertension drug

Rediff.com26 Apr 2004

Ranbaxy Laboratories Ltd has received the US Food and Drug Administration approval to market Fosinopril sodium tablets in the United States.

India can deliver COVID-19 vaccine swiftly and efficiently

India can deliver COVID-19 vaccine swiftly and efficiently

Rediff.com4 Jan 2021

'Rolling out the vaccine is not a major challenge in India.'

Ranbaxy gets US FDA nod for drug

Ranbaxy gets US FDA nod for drug

Rediff.com15 Mar 2004

Ranbaxy Laboratories on Monday said it has received tentative approval from the United States Food and Drug Administration to manufacture and market anti-hypertension drug Quinapril Hydrochloride in the US.

Approval delays to hurt Indian pharma cos' US sales

Approval delays to hurt Indian pharma cos' US sales

Rediff.com13 Nov 2014

Some Indian generic drugmakers are, however, uncertain about the pace of approvals in the near future.

The mistakes Daiichi Sankyo made in the Ranbaxy deal

The mistakes Daiichi Sankyo made in the Ranbaxy deal

Rediff.com12 May 2016

The FDA actions eventually led to a $500-million fine for Ranbaxy as well as the effective mothballing of many of its Indian factories.

Ranbaxy gets US FDA approval for drug

Ranbaxy gets US FDA approval for drug

Rediff.com16 Sep 2003

Ranbaxy Laboratories on Tuesday said it had received approval from US Food and Drug Administration to market a semi synthetic cephalosporin Panixine DisperDose, a generic version of Ceph International Corp, Keflex.

Lupin receives US FDA nod for drug

Lupin receives US FDA nod for drug

Rediff.com28 Jul 2003

Lupin Ltd received US Food & Drug Administration's approval for its abbreviated new drug application for Cefuroxime Axetil tablets.

Ranbaxy got FDA raps on US facilities under Daiichi, too

Ranbaxy got FDA raps on US facilities under Daiichi, too

Rediff.com29 May 2013

The company was indicted for violations at one of its US facilities in 2009, even after Daiichi Sankyo took over as majority shareholder in 2008.

Reddy's get US FDA nod for drug

Reddy's get US FDA nod for drug

Rediff.com10 Jul 2003

Pfizer, BioNTech claim their Covid vaccine over 90% effective

Pfizer, BioNTech claim their Covid vaccine over 90% effective

Rediff.com10 Nov 2020

After discussion with the Food and Drug Administration (FDA), the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases, the statement said.

Ranbaxy may pay $1 bn to settle FDA fine

Ranbaxy may pay $1 bn to settle FDA fine

Rediff.com5 May 2011

Ranbaxy Laboratories and the US health regulator are reportedly negotiating a settlement.

Ranbaxy gets FDA nod for Fluconazole tablets

Ranbaxy gets FDA nod for Fluconazole tablets

Rediff.com6 May 2003

Ranbaxy Laboratories has received tentative approval form the Food & Drug Administration USA for manufacturing and marketing Fluconazole tablets

Rosier year-end seen for Indian pharma, thanks to faster US approvals

Rosier year-end seen for Indian pharma, thanks to faster US approvals

Rediff.com12 Oct 2015

Rosier year-end seen for Indian pharma thanks to faster US approvals.

FIR filed against Snapdeal CEO, directors

FIR filed against Snapdeal CEO, directors

Rediff.com1 May 2015

In April, Snapdeal had said it was delisting the drugs from its portal and was assisting the regulator in the investigation.

Maharashtra asks Snapdeal to stop selling prescription drugs

Maharashtra asks Snapdeal to stop selling prescription drugs

Rediff.com18 Apr 2015

Flipkart, Amazon, too, under radar

Trump defends use of HCQ, says it works in early stages of COVID-19

Trump defends use of HCQ, says it works in early stages of COVID-19

Rediff.com29 Jul 2020

There is no evidence that the drug can fight the virus, and regulators warn it may cause heart problems.

Glenmark gets US FDA nod to sell painkiller drug

Glenmark gets US FDA nod to sell painkiller drug

Rediff.com6 Dec 2010

Glenmark said it along with its US-based partner has got the US health regulator's nod to manufacture and market two oxycodone products, used for treating moderate to severe pain, in the American market. The company's US arm, Glenmark Generics Inc and Lehigh Valley Technologies (LVT) have received US Food and Drug Administration nod for Oxycodone immediate release capsules, the company said in a filing to the Bombay Stock Exchange.

Ranbaxy gets important breather

Ranbaxy gets important breather

Rediff.com11 Oct 2013

Ranbaxy's US factory, Ohm Laboratories, is learnt to have got a clean chit from the American regulator. This US facility was under surveillance of the Food and Drug Administration (FDA) since the end of 2012.

Regulator finds procedural lapses at Wockhardt's US facility

Regulator finds procedural lapses at Wockhardt's US facility

Rediff.com3 Jun 2014

The FDA had imposed a ban on the company's Waluj plant in May.

Mumbai cops grill pharma boss over Remdesivir stock; BJP fumes

Mumbai cops grill pharma boss over Remdesivir stock; BJP fumes

Rediff.com18 Apr 2021

The Bharatiya Janata Party in Maharashtra objected to the pharma executive's grilling by Mumbai police, saying the Shiv Sena-led government in the state was playing politics amid the pandemic.

Serum Institute seeks regular marketing approval for Covishield

Serum Institute seeks regular marketing approval for Covishield

Rediff.com25 Oct 2021

If the DCGI grants regular marketing authorisation, Covishied will be the second vaccine in the world to receive such approval.

US VP Mike Pence receives COVID-19 vaccine on camera

US VP Mike Pence receives COVID-19 vaccine on camera

Rediff.com18 Dec 2020

"Confidence in the vaccine is what brings us here this morning," the US vice-president said in remarks following his vaccination. "I didn't feel a thing. Well done."

UK regulator's import alert on Wockhardt

UK regulator's import alert on Wockhardt

Rediff.com6 Jul 2013

According to the chairman, there will be an annual loss of Rs 100 crore due to the MHRA alert on Waluj plant

Engaged with US entities for procurement of vaccines: MEA

Engaged with US entities for procurement of vaccines: MEA

Rediff.com20 May 2021

India is engaged with American entities for procurement of COVID-19 vaccines from the United States and their possible manufacturing in the country subsequently, the Ministry of External Affairs said on Thursday.