As marketing rights for off-patent drugs in the US become less exclusive, companies are scrambling for fresh strategies to make up for the revenue loss.
Indian drug firms continue to work closely with the FDA, and most have also appointed consultants to help them grasp the regulatory minutiae in the US.
'Sharapova has been a US resident since early in her career, which does bring in a question of how or why she is using a drug that is not licensed there'
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.
The company had posted a consolidated net profit of Rs 323.31 crore (Rs 3.23 billion) in the same period last fiscal, Wockhardt Ltd said in a filing to the Bombay Stock Exchange.
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.
The Aam Aadmi Party on Sunday said Tihar authorities were 'lying' about specialist doctors examining Delhi Chief Minister Arvind Kejriwal, while his wife Sunita Kejriwal alleged that he was being denied insulin for diabetes as 'they want to kill' him.
The Pfizer vaccine has already been approved for the public in the United Kingdom and, Canada.
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.
'The president and this administration have been working very, very hard to make sure we're doing everything we can to work with state and local authorities to try to thwart and disrupt those kinds of attacks and make it clear to anybody who might consider them that they'll be held properly accountable'
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.
Ranbaxy was scheduled to launch its drug on September 21, the day Diovan's patent expired.
Singh says Japanese pharma giant's allegations false.
Large pharmaceutical firms feel that if the quality parameters and assurance levels are brought up to the level of branded generics, then Jan Aushadhi medicines would find it difficult to retain their affordability.
Nestle, the world's largest food company, is seeking to defend its reputation in India after it pulled Maggi noodles from stores.
Data also show that several other leading domestic pharma companies have recalled their products from the US
The company was indicted for violations at one of its US facilities in 2009, even after Daiichi Sankyo took over as majority shareholder in 2008.
There are just 1,500 drug inspectors responsible for more than 10,000 factories in India
USFDA has extended the timeline for granting tentative approval to generic drug applications filed under Para IV of its rules by 10 months.
Vaccine major Serum Institute of India on Tuesday said the approval for the COVID-19 vaccine 'Covovax' would strengthen immunization initiatives across India and various lower and middle income countries across the world.
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.
The Drugs Controller General of India has approved the manufacture of this Sars-CoV-2 spike protein recombinant nano-particle vaccine for 'examination, test, and analysis', reports Sohini Das.
GSK is continuing with investigations into the potential source of the NDMA, which is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
Ranbaxy, its partners and Actavis have signed a non-exclusive agreement.
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.
In a major escalation of the tussle with Punjab Chief Minister Bhagwant Mann, Governor Banwarilal Purohit on Friday warned that he could recommend President's rule in the state and also initiate criminal proceedings if his letters are not answered.
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.
Patient safety and quality our guidance now, says CEO and MD Arun Sawhney.
USFDA consent decree reveals that firm will have to forego huge short-term opportunities for its generics.
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.
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.
During a review, the EC found that the performance of some officers was "unsatisfactory" and they were found "complacent, if not complicit" in various matters, including the illegal supply of liquor as a possible poll inducement, sources said.
Whistle-blower Dinesh Thakur will speak on Made-in-India drugs at an event in Washington.
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.
GlaxoSmithKline Plc's anti-migraine drug brand, Imitrex, is turning out to be a good revenue earner for Indian generic companies.
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.
Both the units were under the scanner of FDA since 2011.
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.
