Ranbaxy's hope of a windfall from the $7-billion Lipitor market in the US is shining again. The US Food and Drugs Administration (USFDA) has taken a strong stance against US-based Mylan, which had opposed FDA's decision to allow approval to Ranbaxy's generic version of Lipitor.
The company has sought the United States Food and Drug Administration (FDA)'s approval to market a generic version of Tamiflu (oseltamivir phosphate), said Gilead Sciences, the US company that owns the Tamiflu patent. Natco officials declined to comment on the development.
He said action was akin to holding highway builders responsible for lane violations
Takeda had filed a case of patent infringement in response to Zydus' abbreviated new drug application.
'The obvious opportunity is biosimilars, which are simpler but more expensive,' says Kiran Mazumdar-Shaw, founder of Biocon.
But the newer entrants prove nimbler than the slowing pioneers.
Generic drugmakers cannot be sued under state law for adverse reactions to their products.
Pharma major Wockhardt on Wednesday said it has launched Tamsulosin capsules, indicated for problem of prostate enlargement, in the US market on the day one of the expiry of patent covering the drug.
The rap from both the US and UK drug regulators, including the latest one from the latter, has hit the scrip.
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.
Earlier last month US FDA officials had seized drug products manufactured by Caraco Pharmaceutical at its Michigan facilities in Detroit, Farmington Hills, and Wixom, alleging violation in good manufacturing practice.
Reduction in customs duty on certain bulk drugs used in making life saving drugs to 5% is a positive for companies having product pipeline catering to these segments.
Heating plastic containers in the microwave releases chemicals that can cause cancer, obesity and infertility.
Indian drug companies have cornered an overwhelming majority of drug approvals under the US President's Emergency Plan for AIDS Relief.
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.
The western world had largely considered India to be a production hub, and also, a good potential geography for clinical trials, and a big market. But in Covid-19 research, Indian companies and government researchers are also researching new drug candidates and potential vaccines, says Prosenjit Datta.
The US subsidiary of Sun Pharmaceuticals, Caraco Pharmaceutical Laboratories, has received a warning letter from the Food and Drug Administration.
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.
Cuomo said he will issue an executive order requiring all people in New York to wear a mask in public and the order will go into effect on April 17.
If the company manages to get a go-ahead from the regulator for this plant, it might result in resumption of supplies of several of their products, barred from the US last year.
Maharashtra government on Friday decided to put a ban on Maggi noodles after some samples were found to contain lead above the permissible limit.
Analysts say those taking exposure through stocks could look at firms focused on domestic business
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 only category of pharmaceuticals that showed a negative growth in exports this time was herbal products, exports of which stood at $299 million as compared to $ 312 million in the previous year.
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.
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.
Beside the defence forces in India, the start-up has shipped around 350,000 units to 12 countries -- the United Kingdom, France, Poland, Bangladesh, Saudi Arabia, the UAE, Kenya, South Africa, Romania, Indonesia, Qatar and Oman.
Last year, the USFDA had banned 30 generic drugs produced at Ranbaxy's plants at Poanta Sahib.
In May this year, Ranbaxy had pleaded guilty to 'felony charges' for violating manufacturing norms and agreed to pay $500 million penalty to US authorities.
The matter is now expected to be raised with the PMO.
US experts were pondering on the safety of food imported into US from developing countries. In lieu of this thought process, a new trend has emerged in America of preferring locally produced food. This trend is affecting Wal Mart and Whole Foods too. It has been observed that when food travels far, the local community are the least benefitted out of the exports. But the trend to grow more locally will seriously affect nations that depend largely on agricultural exports.
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.
Even smaller companies like Torrent Pharma and Alembic file five to 10 ANDAs every year.
The Uttar Pradesh Food and Drug Administration on Tuesday said it has found detergent in one of the samples of Mother Dairy's milk packets, a claim contested by the Delhi-based company.
"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.
Earlier in April, Sun Pharmaceuticals Industries announced acquisition of Ranbaxy in an all-share deal.
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.
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.
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.
Ranbaxy Laboratories on Wednesday hit out at rivals -- "a multinational and a leading Indian company" -- for trying to bring down its share by "spreading confusion and speculation" in the wake of a motion filed in the US accusing it of fraudulent practice and submission of false information to the US FDA.
