GlaxoSmithKline Plc's anti-migraine drug brand, Imitrex, is turning out to be a good revenue earner for Indian generic companies.
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.
Maharashtra Chief Minister Uddhav Thackeray has handed over portfolios of nine rebel ministers, who are currently camping in Guwahati, to other ministers.
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.
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.
Generic drugmakers cannot be sued under state law for adverse reactions to their products.
Both the units were under the scanner of FDA since 2011.
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The company had in May announced that the US Food and Drug Administration had issued an import alert on its Waluj facility, which makes injectables and solid dosages.
Indian drug companies have cornered an overwhelming majority of drug approvals under the US President's Emergency Plan for AIDS Relief.
Ranbaxy, its partners and Actavis have signed a non-exclusive agreement.
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.
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.
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.
Work to begin after that on corrective measures to meet US regulator's requirements.
FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.
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.
Maggi has also come on the radar of US Food and Drug Administration.
Baltimore-based Lupin Pharmaceuticals Inc is recalling 5,60,922 pouches of Mibelas 24 Fe (norethindrone acetate and Ethinyl estradiol tablets and ferrous fumarate tablets) in the US, as per the latest enforcement report by the USFDA.
Data also show that several other leading domestic pharma companies have recalled their products from the US
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.
PPD Inc has acquired exclusive worldwide license to develop, manufacture and market Ranbaxy's cholesterol lowering novel statin.
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.
Tech Mahindra and United Spirits will replace them in the 50-share index of the National Stock Exchange with effect from March 28.
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.
But the newer entrants prove nimbler than the slowing pioneers.
Sun Pharmaceutical Industries said it has received approval from US health regulator to market generic Clarinex tablets and Tiazac capsules, used in treating nasal allergies and hypertension, respectively, in the American market.
The respondents were from over 22 states with 85 percent of them being under 35 years while 61 percent were interns or postgraduate trainees.
In fresh troubles for Nestle over safety standards of its famous Maggi noodle brand, the Uttrakhand Food Safety Department has collected samples of the 'two-minute' noodles from the company's Pantanagar plant and other places in the state.
RPG Life already has marketing tie-ups with Israel's drug major Teva for the EU market and with the US-based Apotex for the Canadian market.
Houston-based biotech firm awaits FDA approvals on its new drug for lung cancer treatment.
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.
Eli Lilly and Company, the US-based multinational pharmaceutical major, has sued Sun Pharmaceuticals in the US, alleging the company infringed its patent on Gemzar, a blockbuster cancer drug.
Hyderabad, Mar 28 (PTI) Dr Reddy's Laboratories Limited has launched Levocetirizine tablets (5mg), a bio-equivalent generic version of Xyzal tablets in the USA market, the company said on Monday.
The US Congressional committee, which is inquiring into the country's Food and Drug Administration's handling of drug-marketing approvals of India's leading drug-maker Ranbaxy, has extended its probe into similar permissions given to Iceland's Actavis.
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.
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."
The Indian pharmaceutical companies are involved in patent litigations of a mere 40 drugs, out of the 135 known patent litigation drugs in the US. This is despite the claims by major Indian players such as Ranbaxy and Dr Reddy's at having secured over 20 first to file status abbreviated new drug applications with the US Food and Drug Administration.
The new regime aims to bring in ease of doing business, as the NITI Aayog has proposed to do away with the need to have manufacturing licences to register medical devices or to get a certificate of compliance.
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.
