Data also show that several other leading domestic pharma companies have recalled their products from the US
The Bihar Police's Economic Offences Unit, which is probing the alleged National Eligibility-cum-Entrance Test (Undergraduate) (NEET-UG) paper leak case, on Saturday claimed to have obtained reference question papers of the test conducted by National Testing Agency (NTA) and planned to compare these with documents recovered from a flat in Patna during a search operation last month.
USFDA has extended the timeline for granting tentative approval to generic drug applications filed under Para IV of its rules by 10 months.
Ranbaxy, its partners and Actavis have signed a non-exclusive agreement.
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.
Joaquin "El Chapo" Guzman Loera was convicted on numerous counts including money laundering, engaging in a continuing criminal enterprise, distribution of heroin and cocaine and other drugs, and illegal arms possession.
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.
Quoting officials, The Washington Post said, the foiled assassination was part of an escalating campaign of aggression by RAW against the Indian diaspora in Asia, Europe and North America.
Ranbaxy has acceded to the request of Health Canada to quarantine drugs produced from its Paonta Sahib facility at Himachal Pradesh, North American country's newspapers reported, highlighting the trouble in store for the Japanese-controlled drug maker. Health Canada is a department of the government of Canada with responsibility for national public health.
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As per the media report, the US Food and Drug Administration is learnt to have issued a Form 483 to the company's manufacturing facility at Mohali a few months ago after finding deviations from norms during an inspection of the plant.
Sameer Kamath, a US citizen, was found dead in the woods on February 5 at approximately 5pm in NICHES Land Trust - Crow's Grove in Williamsport, Indiana.
Patient safety and quality our guidance now, says CEO and MD Arun Sawhney.
Cephalon, a US-based drug maker, has filed a lawsuit against Lupin Ltd and its US subsidiary Lupin Pharmaceuticals for challenging the patents on its sleep disorder drug Nuvigil.
USFDA consent decree reveals that firm will have to forego huge short-term opportunities for its generics.
The police officials said all the five accused will have to undergo the polygraph test, while Sagar and Manoranjan will have to undergo additional naro-analysis and brain mapping tests.
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.
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.
Super Tuesday is an important phase of presidential primaries when the early contests are over, and voters from multiple states cast ballots in primaries timed to occur on the same date. Almost all the results were one-sided in favour of Trump except for Vermont, where the winning difference was about one per cent.
Whistle-blower Dinesh Thakur will speak on Made-in-India drugs at an event in Washington.
The US health authorities registered more than three times as many new cases as in any previous wave of the coronavirus.
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.
The EUA allows for Remdesivir to be distributed in the US and administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalised with severe condition.
Last week, Sun's Israeli subsidiary, Taro Pharma, received the US Food and Drug Administration's approval for its New Drug Application to launch Topicort Topical Spray for the treatment of psoriasis.
GlaxoSmithKline Plc's anti-migraine drug brand, Imitrex, is turning out to be a good revenue earner for Indian generic companies.
Both the units were under the scanner of FDA since 2011.
The company said it is launching the product immediately
In the last one month, Indian pharmaceutical company Lupin has won US Food and Drug Administration nod for three of its contraceptive pills, and has at least nine approvals pending with the regulator.
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.
Indian drug companies have cornered an overwhelming majority of drug approvals under the US President's Emergency Plan for AIDS Relief.
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.
Work to begin after that on corrective measures to meet US regulator's requirements.
Tech Mahindra and United Spirits will replace them in the 50-share index of the National Stock Exchange with effect from March 28.
Easy access to this kind of test could help people determine what kind of precautions they should take against COVID-19 infection, such as getting an additional booster shot, the researchers said.
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.
Chairman of the Department of Surgical Oncology at Lilavati Hospital in Mumbai, Dr P Jagannath shares interesting insights on how detecting cancer early on has helped many survive the disease.
In addition to the US drug regulator, Food and Drug Administration, and rival pharma majors that appear keen to launch litigation against Indian company Ranbaxy, a US citizen has joined the bandwagon by filing a case in the world's biggest drug market.
Approval was given by the United States Food and Drug Administration for an investigational new drug application for ZYGK1, Cadila Healthcare said in a filing to the Bombay Stock Exchange.
More than 200 million Pfizer doses have been administered in the US, and hundreds of millions more worldwide, since December.
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.
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.
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