News for 'Food and Drug Administration'

Medic's murder: IMA survey reveals 35% of doctors feel unsafe

Medic's murder: IMA survey reveals 35% of doctors feel unsafe

Rediff.com30 Aug 2024

The respondents were from over 22 states with 85 percent of them being under 35 years while 61 percent were interns or postgraduate trainees.

PIL in Supreme Court for action against Ranbaxy

PIL in Supreme Court for action against Ranbaxy

Rediff.com5 Jun 2013

An advocate on Wednesday approached the Supreme Court with a PIL seeking cancellation of the license granted to Ranbaxy Laboratories and for initiating probe against the pharma major for allegedly manufacturing and selling adulterated drugs.

Why Zydus is likely to continue with its outperformance

Why Zydus is likely to continue with its outperformance

Rediff.com31 Mar 2023

Even as most of its large-cap pharmaceutical peers have struggled to stay above water on the returns front, Zydus Lifesciences has been one of the big outperformers within the sector over the past year with a return of over 30 per cent. The gains have come on the back of multiple triggers such as the scaling up of new product launches in the US market, clearance for its Moraiya (Gujarat) facility and steady performance in the domestic market. Though it has been the top pharma gainer in the 2022-23 financial year (FY23), brokerages continue to maintain their 'buy' stance, given the strong visibility in the US market.

Indian drug regulator threatens to ban Ranbaxy

Indian drug regulator threatens to ban Ranbaxy

Rediff.com29 Jan 2014

A day after getting a show-cause notice from the Indian regulator, senior executives from Ranbaxy Laboratories approached the drug controller's office on Tuesday afternoon, it was learnt.

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.

After US, Germany bans export of Ranbaxy's Dewas plant drugs

After US, Germany bans export of Ranbaxy's Dewas plant drugs

Rediff.com3 Dec 2014

The company did not comply to the 'good manufacturing practice' norms.

Daiichi was given all updates: Malvinder Singh

Daiichi was given all updates: Malvinder Singh

Rediff.com24 May 2013

Singh says Japanese pharma giant's allegations false.

A Mylan win in US court could hit Ranbaxy

A Mylan win in US court could hit Ranbaxy

Rediff.com4 Oct 2012

Ranbaxy was scheduled to launch its drug on September 21, the day Diovan's patent expired.

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.

Cadila launches Remdesivir in India at Rs 2,800 per vial

Cadila launches Remdesivir in India at Rs 2,800 per vial

Rediff.com13 Aug 2020

The company said the drug will be made available across India through the group's strong distribution chain reaching out to government and private hospitals treating COVID-19 patients.

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.

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.

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.

Health Canada raps Ranbaxy

Health Canada raps Ranbaxy

Rediff.com28 Feb 2009

Ranbaxy has acceded to the request of Health Canada to quarantine drugs produced from its Paonta Sahib facility at Himachal Pradesh, North American country's newspapers reported, highlighting the trouble in store for the Japanese-controlled drug maker. Health Canada is a department of the government of Canada with responsibility for national public health.

Ranbaxy gets US nod to sell Alzheimer's generic

Ranbaxy gets US nod to sell Alzheimer's generic

Rediff.com22 Sep 2010

India's largest drugmaker, Ranbaxy, will have an exclusive six-month marketing opportunity to sell a generic version of Japanese drugmaker Eisai's drug for Alzheimer's in the US.

USFDA to set up office in India

USFDA to set up office in India

Rediff.com18 Nov 2008

The US Department of Health and Human Services has decided to employ 10 full-time officials in Delhi -- a country director, four drug inspectors, two senior technical experts in medicines, two technical experts in medical devices and one from the food sector. 'The purpose of the appointment is to help develop food and medical product regulations and agencies improve product safety and conduct inspections in a more timely manner,' said Christopher Kelly, press officer, USFDA.

Uddhav strips 9 rebel ministers of portfolios, reassigns to others

Uddhav strips 9 rebel ministers of portfolios, reassigns to others

Rediff.com27 Jun 2022

Maharashtra Chief Minister Uddhav Thackeray has handed over portfolios of nine rebel ministers, who are currently camping in Guwahati, to other ministers.

Ranbaxy introduces whistle-blower policy

Ranbaxy introduces whistle-blower policy

Rediff.com27 May 2013

Patient safety and quality our guidance now, says CEO and MD Arun Sawhney.

Now, Hospira under US FDA's lens

Now, Hospira under US FDA's lens

Rediff.com23 Dec 2013

Formal warning to Indian unit of deficiencies noted during inspection at facility near Chennai; firm says will remedy

US firm drags Lupin to court

US firm drags Lupin to court

Rediff.com19 Mar 2010

Cephalon, a US-based drug maker, has filed a lawsuit against Lupin Ltd and its US subsidiary Lupin Pharmaceuticals for challenging the patents on its sleep disorder drug Nuvigil.

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.

Why so many Indian food product exports get rejected

Why so many Indian food product exports get rejected

Rediff.com13 Sep 2016

India consistently ranked among the top three countries whose products were rejected for import by the regulator.

Ranbaxy settles case with USFDA, to pay $500 mn

Ranbaxy settles case with USFDA, to pay $500 mn

Rediff.com21 Dec 2011

Drug-maker Ranbaxy Laboratories on Wednesday said it has signed an agreement with the US health regulator to lift a ban on the import of drugs from certain manufacturing plants in India and will pay up to $500 million to settle a case lodged by the Department of Justice.

Daiichi, Ranbaxy team to counter FDA charges

Daiichi, Ranbaxy team to counter FDA charges

Rediff.com27 Feb 2009

The USFDA has accused Ranbaxy of falsifying data and test results of medicines. A Daiichi Sankyo statement said it takes the issue very seriously. 'Both Daiichi and Ranbaxy have formed a team to solve the issue. Ranbaxy will be responding to the FDA and will continue to cooperate with the agency.' Ranbaxy shares fell more than 18 per cent to Rs 169.85 today on the Bombay Stock Exchange, while Daiichi stock dropped about 10 per cent to yen 1,680 on the Tokyo Stock Exchange.

I can stand behind every pill: Ranbaxy CEO

I can stand behind every pill: Ranbaxy CEO

Rediff.com27 May 2013

The US FDA, during its inspection of Ranbaxy's manufacturing facilities in India, between 2006 and 2008, had found violations, incomplete testing records and an inadequate stability programme, besides manufacturing practices that did not follow regulations.

Indian generics profit from Glaxo patent expiry

Indian generics profit from Glaxo patent expiry

Rediff.com18 Aug 2009

GlaxoSmithKline Plc's anti-migraine drug brand, Imitrex, is turning out to be a good revenue earner for Indian generic companies.

Sun eyes US skincare market

Sun eyes US skincare market

Rediff.com18 Apr 2013

Last week, Sun's Israeli subsidiary, Taro Pharma, received the US Food and Drug Administration's approval for its New Drug Application to launch Topicort Topical Spray for the treatment of psoriasis.

Wockhardt gets USFDA nod for anti-depressant tablets

Wockhardt gets USFDA nod for anti-depressant tablets

Rediff.com3 Sep 2012

The company said it is launching the product immediately

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.

Firms go beyond patent cliff for growth

Firms go beyond patent cliff for growth

Rediff.com29 Jan 2013

In the last one month, Indian pharmaceutical company Lupin has won US Food and Drug Administration nod for three of its contraceptive pills, and has at least nine approvals pending with the regulator.

Lupin recalls 5.61 lakh pouches of India-made birth control pills in US

Lupin recalls 5.61 lakh pouches of India-made birth control pills in US

Rediff.com21 Aug 2020

Baltimore-based Lupin Pharmaceuticals Inc is recalling 5,60,922 pouches of Mibelas 24 Fe (norethindrone acetate and Ethinyl estradiol tablets and ferrous fumarate tablets) in the US, as per the latest enforcement report by the USFDA.

After a year, Aurobindo Pharma starts getting USFDA nod

After a year, Aurobindo Pharma starts getting USFDA nod

Rediff.com4 Jun 2012

Both the units were under the scanner of FDA since 2011.

Sun Pharma ends patent dispute with Actavis

Sun Pharma ends patent dispute with Actavis

Rediff.com6 Oct 2015

Ranbaxy, its partners and Actavis have signed a non-exclusive agreement.

'Made in India' dominates US AIDS scheme

'Made in India' dominates US AIDS scheme

Rediff.com16 Oct 2009

Indian drug companies have cornered an overwhelming majority of drug approvals under the US President's Emergency Plan for AIDS Relief.

Wockhardt gets warning letter from USFDA over Waluj plant

Wockhardt gets warning letter from USFDA over Waluj plant

Rediff.com20 Jul 2013

The company had in May announced that the US Food and Drug Administration had issued an import alert on its Waluj facility, which makes injectables and solid dosages.

Parkinson's medicine in patent tangle

Parkinson's medicine in patent tangle

Rediff.com4 Nov 2008

Drug major Wockhardt has challenged the US patent of Stalevo, a new generation combination drug for the treatment of Parkinson's disease, originated by Finland-based Orion Corporation and marketed by Novartis.

Orion files suit against Wockhardt

Orion files suit against Wockhardt

Rediff.com12 Dec 2008

The Finland-based drug major Orion Corporation has filed a lawsuit in the United States against domestic drug major Wockhardt for challenging the patents on its brand Stalevo, used for the treatment of Parkinson's disease.

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.

Ranbaxy drugs cleared FDA test before import alert

Ranbaxy drugs cleared FDA test before import alert

Rediff.com11 Jun 2013

FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.