'There is no reason why we should break this business up.'
This is not just a Ranbaxy or Wockhardt problem, says K Satish Reddy
Ohm Laboratories Inc, a wholly-owned subsidiary of Ranbaxy has received approval from the US Food and Drug Administration for manufacturing and marketing Valsartan tablets in strengths of 40 mg, 80 mg, 160 mg, and 320 mg on an exclusive basis, Ranbaxy Laboratories said in a statement.
This time food regulators found excess presence of ash content in Maggi
Analysts have turned cautious on Cipla, as the recently issued form 483 by the US FDA with eight observations to its Pithampur (Indore) plant is expected to delay the launch of the company's key generic - Advair - in the US. The Indore plant contributes around 5 per cent of Cipla's revenues, as per analysts' estimates. While the respiratory product, which is used to treat asthma, had cleared the pre-approval inspection of the regulator at the Indore unit; the final approval could be unlikely until the company clears the recent US FDA observations, analysts say.
More than 200 million Pfizer doses have been administered in the US, and hundreds of millions more worldwide, since December.
These four patients were given blood for the treatment of Thalassemia, post which they were found infected.
With all major US export-oriented drug manufacturing plants in the country up for inspection in 2022, some estimates peg that at least 20-30 per cent of the new product launches lined up for the US will be subject to on-site inspection by the US Food and Drug Administration (USFDA). The last two years saw limited physical inspections due to travel restrictions during the pandemic. "Pre-Covid, the frequency and number of inspections of manufacturing plants in India by USFDA had increased significantly," analysts from ICICI Securities Research noted. "With growing ANDA filings, especially for complex products. "We expect this trend to return with the environment normalising," analysts from ICICI Securities Research noted.
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.
Even as most of its large-cap pharmaceutical peers have struggled to stay above water on the returns front, Zydus Lifesciences has been one of the big outperformers within the sector over the past year with a return of over 30 per cent. The gains have come on the back of multiple triggers such as the scaling up of new product launches in the US market, clearance for its Moraiya (Gujarat) facility and steady performance in the domestic market. Though it has been the top pharma gainer in the 2022-23 financial year (FY23), brokerages continue to maintain their 'buy' stance, given the strong visibility in the US market.
According to an official statement, the FDA has determined that the Moderna COVID-19 vaccine has met the statutory criteria for issuance of an emergency use authorisation (EUA).
Alonso said he had huge respect for Hamilton and had no problems with him.
He is currently on a two-day swing to the crucial State of Iowa. On January 15, Iowa would kick off the 2024 Republican presidential primary season.
Nationalist Congress Party leader Ajit Pawar was given the finance and planning portfolio on Friday, nearly two weeks after he broke away from the original party and took oath as Maharashtra's deputy chief minister.
Nestle refused to regret the mistake in a public statement.
Former New Jersey Governor Chris Christie and a Republican presidential aspirant have called his fellow rival Indian-American Vivek Ramaswamy a guy who sounds like ChatGPT and described him as an "amateur" Barack Obama.
The Pfizer vaccine has already been approved for the public in the United Kingdom and, Canada.
A vacation bench of Justices NJ Jamadar and Sharmila Deshmukh passed the decision on Wednesday while hearing a petition filed by the company challenging two orders of the state government.
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.
Mick Schumacher, who will face intense scrutiny as embarks on his Formula One career, said for now he was simply overwhelmed to be following in his father's footsteps and called his promotion a dream come true.
Maggi banned in Delhi for 15 days.
Pfizer and BioNTech SE on Monday said trial results of COVID-19 vaccine showed that it is safe and produced robust neutralising antibody response in children aged five to 11 years, and they plan to seek regulatory approvals as soon as possible.
Overall, the credit profiles of players will be supported by healthy balance sheets and liquidity. Prudence in capital and development expenditure, efficient working-capital management, and recent equity raising will help sustain credit metrics in FY22.
Vice President Mike Pence said Trump had authorised a ban on entry of foreign nationals who travelled to Iran in the last 14 days. The United States also advised its citizens not to travel to parts of South Korea and Italy, from where reports of coronavirus have appeared.
The ICMR has approved over 200 labs (both public and private) for COVID-19 testing through-PCR machines.
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.
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.
US firm Mylan NV received a stern warning from the FDA in August for faulty manufacturing practices at three of its India drugmaking plants.
Some Indian generic drugmakers are, however, uncertain about the pace of approvals in the near future.
The company has launched only 3 new products during 2015 when compared to 14 launches in 2014
The alternative, saline implants, rupture too, but such failures are quickly recognised by women as their breasts deflate.
An end to Sun Pharma founder Dilip Shanghvi's woes are not in sight.
While Reliance Retail did not comment, sources said the company will have to follow order, at least in Delhi.
Lupin was the top gainer after the USFDA cleared its Goa facility
The US Food and Drug Administration (FDA) says it does not follow an India agenda.
What would an Indian American president of the US look like, sound like and act like, especially on issues and policies pertaining to his or her 'mother-land'?, asks N Sathiya Moorthy.
India on Monday raised serious concerns over the USFDA's audit inspections of Indian pharma companies and 'disproportionate penalties' in some instances and said it would submit a discussion document on the issues to the US.
In March, the FDA had issued an import alert, banning formulations and active pharmaceutical ingredients from the factory.
India consistently ranked among the top three countries whose products were rejected for import by the regulator.
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