Regulator says fee would enable it to quicken approval process.
USFDA has extended the timeline for granting tentative approval to generic drug applications filed under Para IV of its rules by 10 months.
Expectations of strong results, consistent performance and investors preference for stocks in the defensive space help the sector outshine broader markets.
'India is too large a place to have just 10 labs performing these Covid-19 tests.'
In 2012, drugs worth $35 billion went off-patent in the US, while the market size of drugs which will see patent expiry in 2013 will halve to $17 billion.
They are tasty, they are calorie-rich, and they are good for your heart. Doesn't that sound contradictory and too good to be true? Well, think again. We're talking about nuts!
Research shows that the following foods are the most pesticide-retentive. So rather than expose yourself to them, here's why you should strictly stick to the organic options.
Once tipped to emerge as the biggest exporter, the pharmaceutical industry is yet to acquire the scale of those in software services, says Krishna Kant.
Import alert on unit-6 facility might be lifted by FDA by Sept.
Cipla is recalling the drug for failed impurities and degradation specifications.
USFDA consent decree reveals that firm will have to forego huge short-term opportunities for its generics.
Mylan had sued the United States Food and Drugs Administration for providing the exclusive right to Ranbaxy, alleging the permission was given on the basis of 'falsified data'.
At present, the service charge for one unit (bag) of blood is Rs 850.
A global policy would reward firms which strive for higher quality.
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 obvious opportunity is biosimilars, which are simpler but more expensive,' says Kiran Mazumdar-Shaw, founder of Biocon.
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
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.
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.
Takeda had filed a case of patent infringement in response to Zydus' abbreviated new drug application.
But the newer entrants prove nimbler than the slowing pioneers.
Generic drugmakers cannot be sued under state law for adverse reactions to their products.
Heating plastic containers in the microwave releases chemicals that can cause cancer, obesity and infertility.
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 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.
The rap from both the US and UK drug regulators, including the latest one from the latter, has hit the scrip.
Check out some of the stocks that will react on the basis of their numbers in the near term.
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.
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.
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.
Indian drug companies have cornered an overwhelming majority of drug approvals under the US President's Emergency Plan for AIDS Relief.
Maharashtra government on Friday decided to put a ban on Maggi noodles after some samples were found to contain lead above the permissible limit.
Investment in market leaders with a safety-first approach could yield reasonable returns across sectors.
The US subsidiary of Sun Pharmaceuticals, Caraco Pharmaceutical Laboratories, has received a warning letter from the Food and Drug Administration.
Analysts say those taking exposure through stocks could look at firms focused on domestic business
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.
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.
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