News for 'US Food and Drug Administration'

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.

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.

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.

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

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.

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.

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.

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

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

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.

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.

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

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

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.

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.

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

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.

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.

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

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.

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.

Ajit Pawar and men win big, Shinde and Co lose out in Maharashtra portfolios

Ajit Pawar and men win big, Shinde and Co lose out in Maharashtra portfolios

Rediff.com14 Jul 2023

Nationalist Congress Party leader Ajit Pawar was given the finance and planning portfolio on Friday, nearly two weeks after he broke away from the original party and took oath as Maharashtra's deputy chief minister.

US gives full approval to Pfizer Covid vaccine

US gives full approval to Pfizer Covid vaccine

Rediff.com23 Aug 2021

More than 200 million Pfizer doses have been administered in the US, and hundreds of millions more worldwide, since December.

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.

Hetero's generic version of remdesivir to be sold @ Rs 5,400/vial

Hetero's generic version of remdesivir to be sold @ Rs 5,400/vial

Rediff.com24 Jun 2020

The company is set to deliver the first set of 20,000 vials in two equal lots of 10,000 each, one of which will be immediately supplied to Hyderabad, Delhi, Gujarat, Tamil Nadu, Mumbai and other parts of Maharashtra, Hetero Healthcare said in a statement.

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.

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.

3-member panel to probe gas leak at Dr Reddy's

3-member panel to probe gas leak at Dr Reddy's

Rediff.com24 Dec 2010

A three-member committee, comprising two officials from the Director of Factories and one pharma expert, will probe the gas leak at a production unit of Dr Reddy's Laboratories (DRL). The Director of Factories will appoint a pharma domain expert soon.

No sabotage at Toansa plant, says Ranbaxy

No sabotage at Toansa plant, says Ranbaxy

Rediff.com12 Feb 2014

Company is among the few companies in the sector getting pulled up by FDA for violations at its factories in India.

Sharapova's intent questioned - Why was she taking banned heart drug?

Sharapova's intent questioned - Why was she taking banned heart drug?

Rediff.com9 Mar 2016

'Sharapova has been a US resident since early in her career, which does bring in a question of how or why she is using a drug that is not licensed there'