News for 'Food and Drug Administration'

Ranbaxy gets USFDA nod for Dispermox

Ranbaxy gets USFDA nod for Dispermox

Rediff.com14 Aug 2003

Ranbaxy Laboratories, in a release issued to the BSE on Thursday, said the US Food and Drug Administration has granted the company permission to market DisperMox (amoxicillin tablets for oral suspension - 200mg and 400mg).\n\n

US sees red over sindoor

US sees red over sindoor

Rediff.com19 Dec 2007

Indian women may consider it sacred to adorn 'Sindoor' (vermilion) on their foreheads, but the United States government has warned against using a particular brand of this toxic 'red powder' due to high lead content.

Indian drug cos to benefit as US expedites generic clearances

Indian drug cos to benefit as US expedites generic clearances

Rediff.com12 May 2014

Even smaller companies like Torrent Pharma and Alembic file five to 10 ANDAs every year.

Ranbaxy gets US nod for Glimepiride

Ranbaxy gets US nod for Glimepiride

Rediff.com7 Oct 2005

Ranbaxy Laboratories Ltd on Friday said it has received approval from the US Food and Drug Administration to manufacture and market multiple dosages of anti-diabetes drug Glimepiride tablets.

As drug firms squirm, authorities look abroad for cure

As drug firms squirm, authorities look abroad for cure

Rediff.com23 Sep 2013

DCGI, health ministry initiate dialogues with foreign regulators, try to understand global best practices

Duty-free shops outside food safety ambit: FSSAI

Duty-free shops outside food safety ambit: FSSAI

Rediff.com11 May 2016

Business of retail, food and beverages at duty-free shops in India was estimated to have a potential of $3.5 billion by 2021.

NRI's energy drink under scanner for 13 deaths in US

NRI's energy drink under scanner for 13 deaths in US

Rediff.com16 Nov 2012

A popular energy drink, produced by a company founded by an Indian-American billionaire, has come under the scanner in the United States after reports of 13 deaths possibly linked to the energy shots.

Wockhardt to launch new antibiotic in US next week

Wockhardt to launch new antibiotic in US next week

Rediff.com2 Jun 2006

The company has already received approval from the US Food & Drug Administration for marketing clarithromycin tablets.

Singapore could be possible site for Ranbaxy arbitration

Singapore could be possible site for Ranbaxy arbitration

Rediff.com3 Jun 2013

The 2008 deal agreement contains provisions of arbitration to be held in that country.

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

Malvinder Singh on Ranbaxy's setback

Malvinder Singh on Ranbaxy's setback

Rediff.com17 Jul 2008

All medicines that have USFDA approvals continue to be produced in the Poanta Sahib facility. The USFDA has not given any approval for new drugs as they have some concerns. We are addressing them, Malvinder Singh said.

SIIto test Novavax's Omicron-specific vaccine

SIIto test Novavax's Omicron-specific vaccine

Rediff.com6 Jun 2022

The Drugs Controller General of India has approved the manufacture of this Sars-CoV-2 spike protein recombinant nano-particle vaccine for 'examination, test, and analysis', reports Sohini Das.

Over 1 million new COVID-19 cases reported in US

Over 1 million new COVID-19 cases reported in US

Rediff.com4 Jan 2022

The US health authorities registered more than three times as many new cases as in any previous wave of the coronavirus.

Dr Reddy's files with US FDA for generic Zofran

Dr Reddy's files with US FDA for generic Zofran

Rediff.com8 May 2003

Indian drugmaker Dr Reddy's Laboratories said on Thursday it had filed an application with the US Food and Drug Administration to market a generic form of GlaxoSmithKline's anti-nausea drug Zofran.\n\n

US allows Ranbaxy to market flecainide acetate

US allows Ranbaxy to market flecainide acetate

Rediff.com1 Apr 2003

In a major boost to Ranbaxy Laboratories' exports to developed countries, the United States has approved marketing of flecainide acetate tablets in the country.

Imitrex delay: Ranbaxy may lose up to Rs 300 cr

Imitrex delay: Ranbaxy may lose up to Rs 300 cr

Rediff.com2 Jan 2009

Drug major Ranbaxy Laboratories could suffer a potential revenue loss to the tune of Rs 300 crore (Rs 3 billion) due to delay in receiving approval from the US Food and Drug Administration (FDA) for generic version of GSK's anti-migraine medicine Imitrex, according to analysts.

Reddy's files with US FDA for generic Olanzapine

Reddy's files with US FDA for generic Olanzapine

Rediff.com11 Mar 2003

Drugmaker Dr Reddy's Laboratories has filed an application with the US Food and Drug Administration to market a generic form of Eli Lilly's schizophrenia drug Olanzapine in the US

Dr Reddy's launches generic Parkinson's disease tablets in US

Dr Reddy's launches generic Parkinson's disease tablets in US

Rediff.com7 Jun 2012

The tablets are bio equivalent generic version of GlaxoSmithKline's Requip XL tablets

Ranbaxy recalls 7.3 cr Gabapentin tablets

Ranbaxy recalls 7.3 cr Gabapentin tablets

Rediff.com16 Nov 2007

In a setback to pharmaceutical major Ranbaxy Laboratories Ltd, the US drug regulator USFDA has directed the company to recall as many as 7.32 crore (73.2 million) Gabapentin tablets of 600 and 800 mg strengths.

Ranbaxy gets FDA nod for Amoxicillin

Ranbaxy gets FDA nod for Amoxicillin

Rediff.com8 Dec 2003

Ranbaxy Laboratories on Monday said it has received final approval from the United States Food and Drugs Administration to manufacture and market Amoxicillin and Clavulnate Potassium tablets, a generic version of GlaxoSmithkline's Augmentin.

Ranbaxy launches Clarithromycin in US

Ranbaxy launches Clarithromycin in US

Rediff.com24 May 2005

Ranbaxy Laboratories Ltd on Tuesday launched its approved generic formulation of Clarithromycin immediate release tablets in the US market.

Manufacturing norms violated: USFDA slams Cadila

Manufacturing norms violated: USFDA slams Cadila

Rediff.com7 Jul 2011

The regulator has given the company 15 days to take corrective measures and report back to it.

Cadbury faces prosecution

Cadbury faces prosecution

Rediff.com7 Oct 2003

Pharma cos on DMF filing spree

Pharma cos on DMF filing spree

Rediff.com12 Jan 2005

J&J seeks permission for trial of 1-shot Covid vaccine in India

J&J seeks permission for trial of 1-shot Covid vaccine in India

Rediff.com20 Apr 2021

The US Food and Drug Administration had in February approved Johnson & Johnson's COVID-19 vaccine that works with just one dose for emergency use.

Ranbaxy gets FDA nod for Metformin

Ranbaxy gets FDA nod for Metformin

Rediff.com12 Sep 2003

Ranbaxy Laboratories on Friday said it had received the United States Food and Drug Administration approval to manufacture and market Metformin HCL oral solution, a drug used by the diabetic patients.

Former Ranbaxy promoters fined Rs 2,600 crore

Former Ranbaxy promoters fined Rs 2,600 crore

Rediff.com5 May 2016

The US arm of Ranbaxy pleaded guilty to seven felonies relating to the manufacture and distribution of certain adulterated drugs

All you want to know about insider trading

All you want to know about insider trading

Rediff.com17 Jun 2008

Insiders who have 'privileged' access to the right information make the gains, while the ordinary investor is left holding overvalued stocks. Here's help to avoid that trap

Parle knocks on Bombay HC doors over Mango Bite

Parle knocks on Bombay HC doors over Mango Bite

Rediff.com17 Oct 2012

On Oct 14, the Maharashtra unit of FDA had ordered recall of entire stock of Kachha Mango Bite from the marketplace.

Ranbaxy to pay heavily for future US violations

Ranbaxy to pay heavily for future US violations

Rediff.com27 Jan 2012

Ranbaxy has also agreed to relinquish any 180-day marketing exclusivity that it might have for three pending generic drug applications.

Maharashtra caps mask prices, N-95 to cost max Rs 49

Maharashtra caps mask prices, N-95 to cost max Rs 49

Rediff.com21 Oct 2020

The Maharashtra government has capped the prices of N-95, double and triple layer masks for suppliers and private hospitals in the wake of the Covid-19 pandemic, state health minister Rajesh Tope has said.

Ranbaxy gets US FDA nod for Cefadroxil dosage

Ranbaxy gets US FDA nod for Cefadroxil dosage

Rediff.com27 Mar 2003

Indian drugmaker Ranbaxy Laboratories Ltd has received approval from the US Food and Drug Administration to market an oral suspension form of Warner Chilcott's Duricef antibiotic, the Bombay Stock Exchange

US regulators recommend pause on J&J vaccine over rare blood clots

US regulators recommend pause on J&J vaccine over rare blood clots

Rediff.com13 Apr 2021

In a joint statement, the CDC and the FDA said they were investigating clots in six women in the days after vaccination, in combination with reduced platelet count.

FDA warns Ranbaxy's American subsidiary

FDA warns Ranbaxy's American subsidiary

Rediff.com24 Dec 2009

The letter mentions certain cGMP violation based on site inspections conducted between July and August 2009.

J&J in talks with India for study of single-dose vaccine

J&J in talks with India for study of single-dose vaccine

Rediff.com9 Apr 2021

India is currently using two vaccines for COVID-19 -- one developed by Oxford University and AstraZeneca and the other developed by Bharat Biotech in collaboration with the Indian Council of Medical Research-National Institute of Virology. Both the vaccines are being manufactured within the country by domestic firms.

Wockhardt hit by FDA alert on another plant

Wockhardt hit by FDA alert on another plant

Rediff.com27 Nov 2013

Its factory in Chikalthana in western India was last month hit by the British drug regulator's curb on imports from the plant over manufacturing deficiencies.

HC raps Pepsico over use of stale ingredients

HC raps Pepsico over use of stale ingredients

Rediff.com31 Aug 2010

Joint Commissioner, Food and Drugs Administration, Pune, had suspended license for its for plants at Ranjangaon and Taregaon after an inspection in May 2009 found that company was using some ingredients which were past their "best before" date.