News for 'US FDA'

Don't need to sell assets, can pay fine: Ranbaxy brothers

Don't need to sell assets, can pay fine: Ranbaxy brothers

Rediff.com25 May 2016

In 2013, Daiichi had launched the arbitration proceedings in Singapore.

Nestle pasta found unsafe, lead beyond permissible limit

Nestle pasta found unsafe, lead beyond permissible limit

Rediff.com27 Nov 2015

After Maggi, the sample of macroni pasta was taken from Mau and sent to National Food Analysis Laboratory.

Maharashtra drug body cracks down on misleading ads

Maharashtra drug body cracks down on misleading ads

Rediff.com7 May 2012

The Maharashtra Food and Drugs Administration has initiated action against manufacturers of medicines and instruments, newspapers, TV channels and cable operators making outrageous claims through advertisements.

India could be 'efficacy test' for TB drug okayed by US

India could be 'efficacy test' for TB drug okayed by US

Rediff.com17 Mar 2013

There are also lingering concerns over the culture of misuse of pharmaceutical products in India, which has, in the past, led to other drugs becoming increasingly ineffective.

Mice, roaches found in food served on US airlines

Mice, roaches found in food served on US airlines

Rediff.com21 Nov 2012

Through a Freedom of Information Act request, the Show '20/20' obtained lists of recent health violation records from the FDA, the agency in charge of inspecting airlines and their outside food caterers.

Ranbaxy expects guidance on Dewas unit by December

Ranbaxy expects guidance on Dewas unit by December

Rediff.com12 Nov 2012

Work to begin after that on corrective measures to meet US regulator's requirements.

New rules for Indian generic drug makers

New rules for Indian generic drug makers

Rediff.com29 Oct 2012

Regulator says fee would enable it to quicken approval process.

Wait for Indian generic launches gets longer

Wait for Indian generic launches gets longer

Rediff.com29 Oct 2012

USFDA has extended the timeline for granting tentative approval to generic drug applications filed under Para IV of its rules by 10 months.

Pharma stocks could rise another 15-20%

Pharma stocks could rise another 15-20%

Rediff.com28 Jul 2014

Expectations of strong results, consistent performance and investors preference for stocks in the defensive space help the sector outshine broader markets.

ICMR plans to scale-up testing capacity to 1 lakh/day

ICMR plans to scale-up testing capacity to 1 lakh/day

Rediff.com6 Apr 2020

The ICMR has approved over 200 labs (both public and private) for COVID-19 testing through-PCR machines.

US allows 'game-changer' saliva-based Covid test

US allows 'game-changer' saliva-based Covid test

Rediff.com16 Aug 2020

The new test it will enable rapid testing amongst more people easily.

Indian majors lead race for US drug ingredient market

Indian majors lead race for US drug ingredient market

Rediff.com30 Jan 2013

In 2012, drugs worth $35 billion went off-patent in the US, while the market size of drugs which will see patent expiry in 2013 will halve to $17 billion.

Moderna says its COVID-19 vaccine is 94.5% effective

Moderna says its COVID-19 vaccine is 94.5% effective

Rediff.com16 Nov 2020

Cambridge, Massachusetts-based Moderna's announcement comes just a week after Pfizer and Biontech said their COVID-19 vaccine candidate was found to be more than 90 per cent effective in preventing COVID-19 in participants.

Cancer, cholesterol, heart health: Why you must eat NUTS

Cancer, cholesterol, heart health: Why you must eat NUTS

Rediff.com11 Oct 2012

They are tasty, they are calorie-rich, and they are good for your heart. Doesn't that sound contradictory and too good to be true? Well, think again. We're talking about nuts!

The dirty dozen: THESE foods are best bought organic

The dirty dozen: THESE foods are best bought organic

Rediff.com5 Jun 2012

Research shows that the following foods are the most pesticide-retentive. So rather than expose yourself to them, here's why you should strictly stick to the organic options.

US drug regulator to inspect Aurobindo facilities

US drug regulator to inspect Aurobindo facilities

Rediff.com16 Aug 2012

Import alert on unit-6 facility might be lifted by FDA by Sept.

How India's pharma growth story fizzled out

How India's pharma growth story fizzled out

Rediff.com5 Jul 2017

Once tipped to emerge as the biggest exporter, the pharmaceutical industry is yet to acquire the scale of those in software services, says Krishna Kant.

Covid-19: How the testing infrastructure is struggling

Covid-19: How the testing infrastructure is struggling

Rediff.com25 Mar 2020

'India is too large a place to have just 10 labs performing these Covid-19 tests.'

Can Ranbaxy recover from its US debacle?

Can Ranbaxy recover from its US debacle?

Rediff.com2 Feb 2012

USFDA consent decree reveals that firm will have to forego huge short-term opportunities for its generics.

Cipla recalls asthma drugs in US

Cipla recalls asthma drugs in US

Rediff.com21 May 2015

Cipla is recalling the drug for failed impurities and degradation specifications.

Pfizer says its Covid vaccine is 95% effective in final trials

Pfizer says its Covid vaccine is 95% effective in final trials

Rediff.com18 Nov 2020

Pfizer and BioNTech said they have concluded phase 3 study of their mRNA-based COVID-19 vaccine candidate BNT162b2, meeting all primary efficacy endpoints.

Ranbaxy Lipitor rights: Mylan challenge dismissed

Ranbaxy Lipitor rights: Mylan challenge dismissed

Rediff.com4 May 2011

Mylan had sued the United States Food and Drugs Administration for providing the exclusive right to Ranbaxy, alleging the permission was given on the basis of 'falsified data'.

Using blood banks in Maharashtra to cost more

Using blood banks in Maharashtra to cost more

Rediff.com4 Mar 2012

At present, the service charge for one unit (bag) of blood is Rs 850.

Indian companies not singled out for inspections: USFDA

Indian companies not singled out for inspections: USFDA

Rediff.com18 Mar 2015

A global policy would reward firms which strive for higher quality.

New hopes for Ranbaxy to grab Lipitor pie

New hopes for Ranbaxy to grab Lipitor pie

Rediff.com8 Apr 2011

Ranbaxy's hope of a windfall from the $7-billion Lipitor market in the US is shining again. The US Food and Drugs Administration (USFDA) has taken a strong stance against US-based Mylan, which had opposed FDA's decision to allow approval to Ranbaxy's generic version of Lipitor.

Natco challenges Gilead's patent on Tamiflu

Natco challenges Gilead's patent on Tamiflu

Rediff.com9 Feb 2011

The company has sought the United States Food and Drug Administration (FDA)'s approval to market a generic version of Tamiflu (oseltamivir phosphate), said Gilead Sciences, the US company that owns the Tamiflu patent. Natco officials declined to comment on the development.

What the future holds for Biocon

What the future holds for Biocon

Rediff.com6 May 2018

'The obvious opportunity is biosimilars, which are simpler but more expensive,' says Kiran Mazumdar-Shaw, founder of Biocon.

'Ham-handed' action against Snapdeal to hurt business: Pilot

'Ham-handed' action against Snapdeal to hurt business: Pilot

Rediff.com3 May 2015

He said action was akin to holding highway builders responsible for lane violations

Zydus infringed Takeda's patent, rules US court

Zydus infringed Takeda's patent, rules US court

Rediff.com20 Jun 2013

Takeda had filed a case of patent infringement in response to Zydus' abbreviated new drug application.

Indian pharma remains top in US generics

Indian pharma remains top in US generics

Rediff.com3 Jan 2011

But the newer entrants prove nimbler than the slowing pioneers.

US justices block generic drug liability lawsuits

US justices block generic drug liability lawsuits

Rediff.com25 Jun 2013

Generic drugmakers cannot be sued under state law for adverse reactions to their products.

Covid-19 could be the boost Indian pharma cos need

Covid-19 could be the boost Indian pharma cos need

Rediff.com20 Sep 2020

The western world had largely considered India to be a production hub, and also, a good potential geography for clinical trials, and a big market. But in Covid-19 research, Indian companies and government researchers are also researching new drug candidates and potential vaccines, says Prosenjit Datta.

Wockhardt launches prostate drug in US market

Wockhardt launches prostate drug in US market

Rediff.com28 Apr 2010

Pharma major Wockhardt on Wednesday said it has launched Tamsulosin capsules, indicated for problem of prostate enlargement, in the US market on the day one of the expiry of patent covering the drug.

GSK withdraws sale of Zinetac after health alert

GSK withdraws sale of Zinetac after health alert

Rediff.com26 Sep 2019

GSK is continuing with investigations into the potential source of the NDMA, which is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Investors concerned about Wockhardt

Investors concerned about Wockhardt

Rediff.com17 Oct 2013

The rap from both the US and UK drug regulators, including the latest one from the latter, has hit the scrip.

Why heating food in microwave is bad for your health

Why heating food in microwave is bad for your health

Rediff.com12 May 2018

Heating plastic containers in the microwave releases chemicals that can cause cancer, obesity and infertility.

New York governor orders residents to wear masks in public

New York governor orders residents to wear masks in public

Rediff.com16 Apr 2020

Cuomo said he will issue an executive order requiring all people in New York to wear a mask in public and the order will go into effect on April 17.

Ranbaxy gets USFDA nod for generic Serzone

Ranbaxy gets USFDA nod for generic Serzone

Rediff.com28 Apr 2003

The United States Food and Drugs Administration has granted Ranbaxy Laboratories a tentative approval to market a generic form of Bristol-Myers' anti-depressant Serzone, US FDA's web site said.

Sun Pharma's US subsidiary to cut jobs

Sun Pharma's US subsidiary to cut jobs

Rediff.com30 Jul 2009

Earlier last month US FDA officials had seized drug products manufactured by Caraco Pharmaceutical at its Michigan facilities in Detroit, Farmington Hills, and Wixom, alleging violation in good manufacturing practice.

India's pharma cos can now invest more in R&D

India's pharma cos can now invest more in R&D

Rediff.com7 Jul 2009

Reduction in customs duty on certain bulk drugs used in making life saving drugs to 5% is a positive for companies having product pipeline catering to these segments.