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.
Billionaire investor Warren Buffett, who is a leading shareholder in Kraft Foods, has warned the US foods firm against overpaying for the British confectionery firm Cadbury, a media report says.
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.
India's largest drug manufacturer, Ranbaxy Laboratories, had falsified data and test results of medicines manufactured at its Himachal Pradesh facility to obtain marketing approval in the United States, says the US Food and Drug Administration.
Last year, the USFDA had banned 30 generic drugs produced at Ranbaxy's plants at Poanta Sahib.
'We say we are proud to be Indian. Can we be proud of such an India where its people are hungry and on the streets?'
US President Barack Obama has signed a historic bill that gives the government powers to curb advertising and promotion of tobacco products.
US food major Kraft has been given a 40 day deadline by the UK panel on takeovers and mergers either to make a formal proposal for British confectionery firm Cadbury or walk away from the deal.
Despite the ongoing trouble India's largest drug maker, Ranbaxy, is facing in the United States, domestic pharmaceutical companies are betting high on the world's largest drug market with added vigour.
Sun Pharma stated the company wanted shareholders' approval to "issue, offer and allot equity shares or non-convertible securities, other than warrants, up to an amount of Rs 12,000 crore ($2 billion), to qualified institutional buyers pursuant to a QIP."
One of the subsidiaries of Sun Pharma has executed a settlement agreement with Novartis, stipulating a dismissal of the lawsuits filed in the United States against the company regarding submission of an Abbreviated New Drug Application for a generic version of Gleevec, the Indian drug major said in a statement.
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.
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.
Ranbaxy's shares jumped almost 10 per cent, having long been depressed by escalating investigations from the US Food and Drug Administration, triggering a ban, which is still in place, that stops the US importing or purchasing the company's drugs. Daiichi Sankyo, the Japanese drugmaker, reiterated on Wednesday that it would stick to its June offer to buy Ranbaxy in spite of its recent troubles.
The US Food and Drug Administration has issued two warning letters to Ranbaxy claiming procedural violations at its plants in Dewas and Paonta Sahib in India. Giuliani, a high-profile Republican leader and former US attorney in Manhattan, would provide advice and review compliance issues. Ranbaxy has been accused of selling generic drugs which did not meet FDA standards.
Domestic firms Aurobindo Pharma, Glenmark Pharmaceuticals and Natco Pharma have received US health regulator's approval to market their generic Rizatriptan Benzoate orally disintegrating tablets used for treating migraine in the American market.
Suit alleges fraud by hiding significant deficiencies in CGMP regulations enforced by US health regulator.
Pharma was the top losing index amid worries about their earnings outlook with Lupin down over 4%
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.
The US Food and Drug Administration (USFDA) has asked Caraco Pharmaceutical Laboratories, the US subsidiary of Mumbai-based Sun Pharmaceuticals Industries, to withdraw many batches of its generic Metformin Hydrochloride tablets used for treating diabetes, citing efficacy and quality issues. According to a USFDA Class II withdrawal announced on March 19, Caraco will have to withdraw seven lots of Metformin Hydrochloride in bottles of 100, 500 and 1000 tablets each.
The company has got the approval for the generic version of Roche's anti-viral 'Valcyte', which has a total annual market of around $239 million. Ranbaxy believes that it has First-to-File status on Valganciclovir tablets, thereby, providing a potential of 180-days of marketing exclusivity which offers a significant opportunity in the future, the company said.
The BSE Midcap also cut all its intraday gains to shed 0.3% at close
The US Food and Drug Administration has asked USV to probe employees who might have been responsible for inaccurate data reporting.
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.
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.
An Egyptian woman, who was among 960 foreign nationals evacuated by India from Yemen, has lauded Indian Army for rescuing her from the strife-torn country.
Sensex, Nifty put up a good show in closing trade.
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.
Experts said it is the first time that an Indian pharmaceutical company has been charged with such serious offences, and that the firm may be prosecuted if the allegations are proved. Able Labs of the US, now a unit of Sun Pharma through an acquisition in 2005, had to face similar charges in 2004-2005.
"We are responding to all queries from US FDA and will emerge as a stronger player in the world's biggest pharmaceutical market," Ranbaxy Chairman and Managing Director Malvinder Singh said. The US, which accounts for 20 per cent of Ranbaxy's $1.5-billion annual turnover, has an import restriction on 30 of its medicines by the US Food and Drugs Authority.
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.
Ranbaxy Laboratories is recalling 29,790 blister packs of anti-allergy drug in the US, manufactured by its arm Ohms Laboratories, due to defective packaging.
Sanjeev Dani, senior vice-president and regional director, Asia and CIS, Ranbaxy, said, "We are pleased to partner with Sirtex. We shall work towards creating a productive relationship."
Two United States senators have asked the US Food and Drug Administration (USFDA) to provide details of market approvals given to all medicines sold by India's largest drug-maker Ranbaxy in that country.
The FDA actions eventually led to a $500-million fine for Ranbaxy as well as the effective mothballing of many of its Indian factories.
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.
Indian companies have made acquisitions of $1 billion so far in January
On BSE, 1,469 shares fell and 1,200 shares rose. A total of 190 shares were unchanged.
The company has received the tentative approval from the US Food & Drug Administration to manufacture and market these combination tablets in strengths of 600mg/300mg/ 300mg, a statement by Aurobindo Pharma said.
The US Food and Drug Administration has tightened rules for selling dietary supplements in the US market, making compliance with current good manufacturing practices mandatory for manufacturers.
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