Margaret A Hamburg, the first commissioner of the US Food and Drug Administration (US FDA) to visit India officially, will meet heads of major domestic pharma companies such as Ranbaxy, Wockhardt, Cadila Healthcare and Lupin in New Delhi.
'Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization for its COVID-19 vaccine in India'
Both the units were under the scanner of FDA since 2011.
The recalled drugs were manufactured and distributed in the US by Ohm Laboratories.
Indian drugmaker Dr Reddy's Laboratories said on Thursday it had filed an application with the US Food and Drug Administration to market a generic form of GlaxoSmithKline's anti-nausea drug Zofran.\n\n
Ranbaxy Laboratories, Dr Reddy's Laboratories and Sun Pharma's US subsidiary Caraco Pharmaceuticals are among the 13 generic manufacturers to get first generic approvals from the US Food and Drug Administration to manufacture and market generic versi
Slapped with Rs 242-crore fine by US authorities for rule violations at Toansa unit, say sources; 2nd such hefty rap in the recent past from US regulators for bending rules.
Company is among the few companies in the sector getting pulled up by FDA for violations at its factories in India.
The US laws authorise the drug and health watchdog to assess and collect user fees for certain applications and supplements for human generic drug products
The news that exports to the US will not restart before next year as well as the September quarter performance are sentiment dampeners.
Speaking at the Conservative Political Action Committee in Orlando, Florida on Sunday, the 74-year-old leader, who left the White House on January 20, stopped short of announcing to run for the president in 2024, although he gave enough indications that he is moving in that direction.
Meticulous hand washing is your best bet to get rid of the grime that clings to the hand, that might harbour nasty pathogens, including the coronavirus.
'We lost our place in being first in the epidemic, when it hit India so hard, but we were actually the epicentre of the epidemic from essentially April 2020, for almost an entire year. We had such high cases. We were the country that had the most mixed response.'
This time food regulators found excess presence of ash content in Maggi
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.
The news comes as the United States approaches 300,000 deaths from COVID-19.
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 US Food and Drug Administration has issued two warning letters to Ranbaxy claiming procedural violations at its plants in Dewas and Paonta Sahib in India. Giuliani, a high-profile Republican leader and former US attorney in Manhattan, would provide advice and review compliance issues. Ranbaxy has been accused of selling generic drugs which did not meet FDA standards.
Should Indian cigarette packs also have photos like these to dissuade smokers? Tell us now!
These vaccines have not yet been approved by the World Health Organization
'The government had a vaccine from January.' 'The government should have given the vaccine to all population above the age of 45, right from the start.' 'Each state has its own problems, but as far as vaccine coverage in India is concerned, there have been mistakes.'
The Maharashtra Food and Drug Authority has issued notice to Johnson and Johnson, as six products including baby shampoo and baby oil were found to have carcinogenic substances.
The labs have been asked to submit their report within six weeks.
The Maharashtra Food and Drug Administration seized gutkha worth over Rs 7 lakh from various parts of the state over the last two days in an effort to enforce the ban on gutkha sales.
The Maharashtra Food and Drug Administration has issued a show cause notice to a Pune-based diversified group for putting 'objectionable' label in its bottled mineral water and seized water bottles worth Rs 245,000 from Aurangabad.
There are just 1,500 drug inspectors responsible for more than 10,000 factories in India
Dr Reddy's gets warning from US health regulator
Illustrious international thinkers met at the Milken Institute Global Conference 2021 and many discussions addressed the impact of the COVID-19 pandemic on the world at large.
As the global debate on booster shots gathers momentum, several scientists in New Delhi said the priority must be to ensure that more people are inoculated with at least their first jab.
As states grapple with a shortage of coronavirus vaccines, the Centre on Thursday said that over two billion doses will be made available in the country in five months between August and December, enough to vaccinate the entire population.
With an increasing number of people from the Indian-American community playing a significant role in US elections, Congressman Raja Krishnamoorthi said there is a realisation among them that "if you don't have a seat at the table, you're on the menu -- that is why they are voting and running for office in large numbers".
Low growth visibility and trouble with regulators have resulted in lack of interest from investors
US District Judge Beryl Howell in Minneapolis denied Ranbaxy's request, the court filing showed.
Only 11 antibiotics in clinical trials have received qualified infectious disease product status from the US FDA, of which five are Wockhardt's drugs.
This may include Rs 1,500 as a screening test for suspect cases and an additional Rs 3,000 for confirmation test, the guidelines said.
In 2014, Sun Pharma agreed to buy Ranbaxy -- which was then controlled by Daiichi.
The first two coaches that rolled out from the Railway Coach Factory in Kapurthala also have fixtures coated with titanium dioxide and the provision for plasma air equipment in AC ducts to sterilise interiors using ionised air. Railway Minister Piyush Goyal also indicated that the new coaches could be the new normal.
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