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.
Formal warning to Indian unit of deficiencies noted during inspection at facility near Chennai; firm says will remedy
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.
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.
India consistently ranked among the top three countries whose products were rejected for import by the regulator.
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.
Generic drugmakers cannot be sued under state law for adverse reactions to their products.
GlaxoSmithKline Plc's anti-migraine drug brand, Imitrex, is turning out to be a good revenue earner for Indian generic companies.
Children who previously had COVID-19 or the inflammatory condition MIS-C are not protected against the Omicron variant of coronavirus, according to a study which found vaccination, however, does afford protection.
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
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.
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.
FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.
Ranbaxy, its partners and Actavis have signed a non-exclusive agreement.
Both the units were under the scanner of FDA since 2011.
Indian drug companies have cornered an overwhelming majority of drug approvals under the US President's Emergency Plan for AIDS Relief.
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.
Work to begin after that on corrective measures to meet US regulator's requirements.
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.
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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.
India's drug regulator has initiated a probe and sought further details from the WHO after the global health body issued an alert that cough syrups manufactured by an Indian firm could potentially be linked to the death of children in Gambia.
Data also show that several other leading domestic pharma companies have recalled their products from the US
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.
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.
The Pfizer vaccine has already been approved for the public in the United Kingdom and, Canada.
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.
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.
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.
Tech Mahindra and United Spirits will replace them in the 50-share index of the National Stock Exchange with effect from March 28.
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 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.
In contrast with their strong performance in 2020 and 2021, pharmaceutical and healthcare funds experienced a decline in 2022, with returns plummeting by an average 9.8 per cent. This trend has continued in the current year, with year-to-date return remaining in the negative (-4.9 per cent). In the past three months, pharma funds have been hit hard, experiencing a 7.9 per cent decline.
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