News for 'Food and Drug Administration'

Why drug firms' Q2 revenue growth is likely to dip

Why drug firms' Q2 revenue growth is likely to dip

Rediff.com12 Oct 2018

Currency played an important role in Q2, with US dollar, Japanese yen and euro appreciating vis-a-vis the Indian rupee, while the Brazilian real, South African rand and Russian ruble depreciating against rupee.

India keen on pharma exports to China

India keen on pharma exports to China

Rediff.com16 Mar 2011

China's API exports to India touched $3.3 billion last year, while Indian drugs struggled to post $500 million worth of exports to China.

Sun Pharma, Forest settle US suit on Lexapro

Sun Pharma, Forest settle US suit on Lexapro

Rediff.com13 Jul 2009

Sun Pharmaceutical Industries and its subsidiary, Caraco Pharmaceutical Laboratories, have reached a settlement agreement with drugmaker Forest Laboratories and licensing partner H Lundbeck AS, over a pending patent infringement dispute over Forest's blockbuster antidepressant, Lexapro.

Dr Reddy's gets USFDA nod for glimepiride

Dr Reddy's gets USFDA nod for glimepiride

Rediff.com10 Oct 2005

Hyderabad based Dr Reddy's Laboratories has received approval from the US Food and Drugs Administration for multiple strengths of anti-diabetes drug glimepiride tablets.

Alembic seeks allies in US to double sales

Alembic seeks allies in US to double sales

Rediff.com8 Sep 2008

The Rs 1,027-crore (Rs 10.27 billion) company has filed 13 abbreviated new drug applications and 22 drug master files with the US Food and Drug Administration and regulatory agencies in Europe for supply of formulations and active pharmaceutical ingredients. Some of the ANDAs challenge innovator patents and the company's strategy will be to partner with established companies in the US and Europe for marketing formulations, said Pranav Amin, director, Alembic.

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.

Lupin's US arm gets USDFA nod for insomnia tablets

Lupin's US arm gets USDFA nod for insomnia tablets

Rediff.com22 Mar 2010

The company has received a tentative approval for the company's abbreviated new drug application for Eszopiclone tablets from the US Food and Drug Administration, Lupin said in a filing to the Bombay Stock Exchange.

Now, Pfizer, Novartis, GSK under USFDA scanner

Now, Pfizer, Novartis, GSK under USFDA scanner

Rediff.com19 Jul 2008

Amid reports of a US Congress probe against India's largest drug maker Ranbaxy Laboratories, data show that many leading multinational companies such as Pfizer, GlaxoSmithKline, Novartis and Merck are also under the scanner of the US drug regulator, for more or less similar violations as Ranbaxy is alleged to have committed.

Ranbaxy gets nod for Fluoxetine

Ranbaxy gets nod for Fluoxetine

Rediff.com15 Dec 2004

United States' Food and Drug Administration has granted approval to Ranbaxy Laboratories Ltd to manufacture and market 40 mg capsules of Fluoxetine, a drug used in treatment of obsessive-compulsive disorders.\n\n

USFDA bans more products from Ranbaxy

USFDA bans more products from Ranbaxy

Rediff.com24 Jan 2014

The move follows an FDA inspection of a Ranbaxy facility which identified significant violations of sound manufacturing practices.

Issues with USFDA to take long to resolve: Ranbaxy

Issues with USFDA to take long to resolve: Ranbaxy

Rediff.com9 Nov 2009

Last year, the USFDA had banned 30 generic drugs produced at Ranbaxy's plants at Poanta Sahib.

AstraZeneca sues Ranbaxy over Nexium

AstraZeneca sues Ranbaxy over Nexium

Rediff.com23 Nov 2005

AstraZeneca files suit against Ranbaxy

AstraZeneca files suit against Ranbaxy

Rediff.com22 Nov 2005

Global pharma firm AstraZeneca on Tuesday said it had filed a lawsuit in the United States District Court of New Jersey

India probes four cough syrups after 66 Gambian children's deaths

India probes four cough syrups after 66 Gambian children's deaths

Rediff.com6 Oct 2022

India's drug regulator has initiated a probe and sought further details from the WHO after the global health body issued an alert that cough syrups manufactured by an Indian firm could potentially be linked to the death of children in Gambia.

FDA asks stent makers to get DGCI approval

FDA asks stent makers to get DGCI approval

Rediff.com13 Jun 2005

Acting swiftly on the controversy regarding illegal drug-coated stents, the Maharashtra Food and Drug Administration has asked all stent manufacturers and importers to get valid licenses within the next two months from the Drugs Controller General of

Does US face agricultural terrorism?

Does US face agricultural terrorism?

Rediff.com10 Mar 2008

US experts were pondering on the safety of food imported into US from developing countries. In lieu of this thought process, a new trend has emerged in America of preferring locally produced food. This trend is affecting Wal Mart and Whole Foods too. It has been observed that when food travels far, the local community are the least benefitted out of the exports. But the trend to grow more locally will seriously affect nations that depend largely on agricultural exports.

India acts to repair reputation as drugs exporter

India acts to repair reputation as drugs exporter

Rediff.com7 May 2014

As part of the charm offensive, New Delhi has invited global regulators -- including the FDA -- to visit Indian production units to get first-hand evidence of measures taken to ensure the quality of locally manufactured generics.

Why Ranbaxy's big setback is not yet over

Why Ranbaxy's big setback is not yet over

Rediff.com18 Sep 2013

US drug regulator's fiat on Mohali factory, after strictures on the two other major Indian units, has numerous negative implications.

Sun Pharma gets USFDA nod for anti-cancer injection

Sun Pharma gets USFDA nod for anti-cancer injection

Rediff.com5 Feb 2013

This generic Doxorubicin HCl Liposome injection USP, 2 mg/ml is therapeutically equivalent to Doxil Liposome Injection, 2 mg/ml of Janssen Research and Development, LLC.

Cloud over US FDA inspection

Cloud over US FDA inspection

Rediff.com19 Jul 2008

Two US Congress members have expressed doubts over the quality of inspections conducted by the US Food and Drugs Administration (FDA) on Indian drug manufacturing facilities.

Kejriwal needs no insulin: Tihar; Wife says they want to kill him

Kejriwal needs no insulin: Tihar; Wife says they want to kill him

Rediff.com21 Apr 2024

The Aam Aadmi Party on Sunday said Tihar authorities were 'lying' about specialist doctors examining Delhi Chief Minister Arvind Kejriwal, while his wife Sunita Kejriwal alleged that he was being denied insulin for diabetes as 'they want to kill' him.

Why Daiichi is taking Malvinder Singh to court

Why Daiichi is taking Malvinder Singh to court

Rediff.com27 Nov 2013

The Japanese company alleges the earlier Ranbaxy promoters withheld crucial information when they sold the company in 2008.

Cadila gets tentative FDA nod

Cadila gets tentative FDA nod

Rediff.com15 Jun 2006

Cadila Healthcare Ltd has received tentative approval from the USFDA to market Pravastatin Sodium Tablets in the US market.

Why Wockhardt's Waluj facility is under lens

Why Wockhardt's Waluj facility is under lens

Rediff.com18 Nov 2013

After recovering from issues such as defaults on foreign currency convertible bonds and piling debts, pharmaceutical major Wockhardt has been on the slow lane through the last six months, following warnings from global regulators such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare Products Regulatory Agency.

Ranbaxy gets USFDA approval for carvedilol tablets

Ranbaxy gets USFDA approval for carvedilol tablets

Rediff.com25 Oct 2004

Pharmaceutical giant Ranbaxy on Monday said that it has received tentative approval from the US Food and Drug Administration to manufacture and market carvedilol tablets for treatment of cardiac disorders including hypertension.\n\n\n\n

Now, easy to buy Viagra in China

Now, easy to buy Viagra in China

Rediff.com30 Sep 2004

The popular anti-impotence drug will be available in about 2,000 drugstores in major cities.

Breast milk compound could fight cancer

Breast milk compound could fight cancer

Rediff.com26 Feb 2008

A slight variation of lactoferrin, known as talactoferrin alfa, helps fight lung cancer, according to research by Dr Atul Varadhachary, president and chief operating officer of the Houston-based Agennix.

Why Nestle is willing to engage with food regulator constructively

Why Nestle is willing to engage with food regulator constructively

Rediff.com14 Sep 2015

The high court had given the company six weeks for retesting.

Ranbaxy gets USFDA nod for Atenolol tabs

Ranbaxy gets USFDA nod for Atenolol tabs

Rediff.com2 Jan 2007

Ranbaxy Pharmaceuticals Inc said on Tuesday it has received US Food and Drug Administration's approval for manufacturing and marketing cardiovascular drug -- Atenolol tablets in the US.

Taro faces ban on products in US market

Taro faces ban on products in US market

Rediff.com11 Feb 2009

If Taro fails to address the issues raised by the US Food and Drug Administration, it may face ban on many of its products in the US market, made from the facility at Ontorio, Canada. If Taro fails to address the issues raised by the US Food and Drug Administration, it may face ban on many of its products in the US market, made from the facility at Ontorio, Canada. If Taro fails to address the issues raised by the US FDA, it may face ban on many of its products.

Lupin pills hit legal wall in United States

Lupin pills hit legal wall in United States

Rediff.com12 Oct 2009

Teva Women's Health filed a suit this week in the US District Court for New Jersey, claiming that Lupin had filed an abbreviated new drug application with the US Food and Drug Administration, which infringes the patents of Seasonale, its oral contraceptive that limits the number of menstrual periods women have in a year.

Dr Reddy's files for generic Allegra in US

Dr Reddy's files for generic Allegra in US

Rediff.com26 Mar 2003

Indian drugmaker Dr Reddy's Laboratories Ltd said on Wednesday it has filed with the US Food and Drug Administration to market a generic version of Aventis Pharmaceuticals' anti-allergy drug Allegra.

JB Chem files 1st ANDA, US FDA

JB Chem files 1st ANDA, US FDA

Rediff.com16 Jan 2003

JB Chemicals & Pharmaceuticals Ltd on Thursday announced the filing of its first Abbreviated New Drug Application with the United States Food and Drug Administration.

Meet India's 10 new dollar billionaires

Meet India's 10 new dollar billionaires

Rediff.com22 Jul 2014

The number of dollar billionaires in India has risen to 55 this year from 46 last year.

Covovax nod to boost vaccination drive in India: SII

Covovax nod to boost vaccination drive in India: SII

Rediff.com28 Dec 2021

Vaccine major Serum Institute of India on Tuesday said the approval for the COVID-19 vaccine 'Covovax' would strengthen immunization initiatives across India and various lower and middle income countries across the world.

It's a tough road ahead for pharma companies

It's a tough road ahead for pharma companies

Rediff.com29 May 2013

Post Ranbaxy episode, domestic pharma companies may face frequent inspections and deeper scrutiny.

Where to buy medicines during Mumbai's chemists strike

Where to buy medicines during Mumbai's chemists strike

Rediff.com14 Oct 2012

The Maharashtra State Chemists and Druggists Association has called for a three-day token strike from October 16-18, to protest alleged harassment by the Food and Drugs Administration officials.