Cadila Healthcare Ltd has received tentative approval from US FDA to market its antibiotic, Gatifloxacin tablets, 200 mg and 400 mg, in the US market.
A team at Bristol University used recently developed techniques to validate that the vaccine accurately follows the genetic instructions programmed into it by the Oxford University team.
Earlier in April, Sun Pharmaceuticals Industries announced acquisition of Ranbaxy in an all-share deal.
Cadila Healthcare Ltd on Monday said it has received tentative approval from the US FDA to market Levofloxacin tablets of 250 mg, 500 mg and 750 mg in the US market.
The ICMR has approved over 200 labs (both public and private) for COVID-19 testing through-PCR machines.
With the US education system operating independently from the government, universities are adopting varying strategies when it comes to Covid vaccination.
Biotech major Biocon will file an application with the US Federal Drug Administration to begin clinical trials for oral insulin, which, it says, would be the world's first insulin that could be consumed orally.
The Competition Commission of India and the US Federal Trade Commission are yet to give their nod to the biggest pharma merger and acquisition deal this year in the Asia-Pacific region.
Global generic drugs producer Sandoz has opened its third plant in India at Navi Mumbai with annual production capacity of one billion tablets and capsules.
Only 11 antibiotics in clinical trials have received qualified infectious disease product status from the US FDA, of which five are Wockhardt's drugs.
Dr Reddy's shrugged off recent volatility on Wednesday and moved tenaciously on filing new gernerics with the US FDA.
In 2013, Daiichi had launched the arbitration proceedings in Singapore.
Riluzole is indicated for the treatment of amyotrophic lateral sclerosis.
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 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.
Of the 23 Indian billionaires mentioned in the Bloomberg Billionaires Index, only one saw a reduction in net worth, with the companies owned by most of them outperforming the Nifty 50 index by a big margin.
The broader markets ended negatively with mid-caps and small-caps shedding 0.5 per cent on the BSE.
FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.
A key lesson for the pharmaceutical sector in this case is to not downplay the significant impact that regulatory non-compliance can have on operations.
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.
Lupin was the top gainer after the USFDA cleared its Goa facility
These drugs will be entering in their global Phase -3 clinical trials early next year.
Lupin will fund the buy through $100 mn cash reserves and a bridge loan.
Singh brothers might be stopped by 'fit & proper' hurdle due to US drug norm violations; firm says confident of qualifying.
The 50-share NSE Nifty stayed in the positive zone and retook the 9,900-mark to hit a high of 9,905.05 as buying paced up towards the fag end. It settled higher by 72.45 points, or 0.74 per cent, at 9,899.60.
In its daily briefing, the government also reported Goa is now free of coronavirus.
According to the petition copies, Hospira has alleged that Aurobindo's Abbreviated New Drug Application (ANDA) to make generic version of dexmedetomidine hydrochloride injection would infringe its patented drug Precedex.
The procedure, however, would cost around Rs 75,000-100,000 more than conventional angioplasty.
In the Sensex pack, ICICI Bank emerged as the top gainer by rising 0.97 per cent, while Tata Steel advanced 0.92 per cent.
Maharashtra's Food and Drugs Administration on Wednesday argued in the Bombay High Court that Nestle India.
An International Policy Network report in 2010 found that seven per cent of drugs bought from wholesale traders were substandard, and 3.6 per cent of the drugs from traders contained no active ingredient whatsoever.
Suit alleges fraud by hiding significant deficiencies in CGMP regulations enforced by US health regulator.
'India is too large a place to have just 10 labs performing these Covid-19 tests.'
Check out some of the stocks that will react on the basis of their numbers in the near term.
