News for 'Ranbaxy's US Food and Drug Administration'

Ranbaxy asks 2 execs to exit

Ranbaxy asks 2 execs to exit

Rediff.com10 Nov 2010

According to a report, the executives are T G Chandrashekhar, vice-president, global quality and analytical research, and Abha Pant, executive director for regulatory affairs.

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.

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.

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 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.

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.

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

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.

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.

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.

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.

Ranbaxy gets US nod for Ofloxacin

Ranbaxy gets US nod for Ofloxacin

Rediff.com3 Sep 2003

Indian drug major Ranbaxy Laboratories has got the US Food and Drug Administration nod for the manufacture and sale of Ofloxacin tablets.

Ranbaxy gets FDA nod for Loratidine

Ranbaxy gets FDA nod for Loratidine

Rediff.com21 Aug 2003

Ranbaxy Laboratories on Thursday said it had received Abbreviated New Drug Application approval from the US Food and Drug Administration to manufacture and market Loratidine

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.

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.

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

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 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 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.

Ranbaxy gets FDA nod for Topiramate

Ranbaxy gets FDA nod for Topiramate

Rediff.com17 Dec 2004

Pharma major Ranbaxy Laboratories Ltd on Friday said it has received tentative approval from the US Food and Drug Administration to manufacture and market 25 mg, 100 mg and 200 mg Topiramate tablets.

Ranbaxy, JP Associates to exit Nifty from Mar 28

Ranbaxy, JP Associates to exit Nifty from Mar 28

Rediff.com27 Feb 2014

Tech Mahindra and United Spirits will replace them in the 50-share index of the National Stock Exchange with effect from March 28.

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 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.

Ranbaxy gets FDA nod for Modafinil

Ranbaxy gets FDA nod for Modafinil

Rediff.com23 Feb 2004

Ranbaxy Laboratories said on Monday that it has received tentative approval from the US Food and Drug Administration to manufacture and market Modafinil tablets, a generic of Cepahalon's Provigil.

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.

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

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.

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.

Ranbaxy gets FDA nod for Isotretinoin capsules

Ranbaxy gets FDA nod for Isotretinoin capsules

Rediff.com23 Jun 2003

Ranbaxy Laboratories on Monday said it has received the US Food and Drug Administration's approval to manufacture and market Isotretinoin capsules, a generic version of Hoffman LaRoche's Accutane.

Ranbaxy to market Cefprozil in USA

Ranbaxy to market Cefprozil in USA

Rediff.com15 Dec 2006

Ranbaxy Laboratories will soon join the select club of Indian pharmaceutical majors and have a share in the $76.6 million generics market for anti-infective Cefprozil tablets in the US.

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.

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.

Why US doctors want Indian drugs to be banned

Why US doctors want Indian drugs to be banned

Rediff.com24 Mar 2014

In the final part of a three-part series on America's war on substandard Indian generic drugs, Aziz Haniffa speaks about American doctors' contempt for drugs exported from India and the ineptitude of the US Food and Drug Administration to stop the menace.

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

Recent drug recalls worry investors

Recent drug recalls worry investors

Rediff.com19 Mar 2013

Many say trend could lead to concerns on manufacturing quality in Indian facilities.

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.

Indian regulator also scans Ranbaxy

Indian regulator also scans Ranbaxy

Rediff.com20 Sep 2013

The move comes in the wake of many facilities of Ranbaxy in India being barred by the US Food and Drugs Administration for supplying medicines to the US.

Sun, Ranbaxy hit by US patent counter-suits

Sun, Ranbaxy hit by US patent counter-suits

Rediff.com15 Jun 2010

US-based Abbott Laboratories has sued Sun Pharmaceutical Industries and Ranbaxy Laboratories in courts there for challenging the patents of its cholesterol-lowering drugs, Niaspan and TriCor, respectively, in separate infringement suits.