Indian drug firms continue to work closely with the FDA, and most have also appointed consultants to help them grasp the regulatory minutiae in the US.
The company is set to deliver the first set of 20,000 vials in two equal lots of 10,000 each, one of which will be immediately supplied to Hyderabad, Delhi, Gujarat, Tamil Nadu, Mumbai and other parts of Maharashtra, Hetero Healthcare said in a statement.
The law bans fruit and spice-flavoured cigarettes, slaps expansive new warnings on packages and gets rid of the monikers 'light' and 'low-tar'.
In a joint statement, the CDC and the FDA said they were investigating clots in six women in the days after vaccination, in combination with reduced platelet count.
India is currently using two vaccines for COVID-19 -- one developed by Oxford University and AstraZeneca and the other developed by Bharat Biotech in collaboration with the Indian Council of Medical Research-National Institute of Virology. Both the vaccines are being manufactured within the country by domestic firms.
The Drugs Controller General of India has approved the manufacture of this Sars-CoV-2 spike protein recombinant nano-particle vaccine for 'examination, test, and analysis', reports Sohini Das.
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.
The Maharashtra Food and Drug Administration has directed Parle Exports, manufacturers of Bisleri bottled water, not to release the product in the market till further orders.
Mumbai-based pharma major Lupin will invest over Rs 200 crore (Rs 2 billion) this year to create additional manufacturing capacities.
Retail chain Subhiksha feels it is being unfairly targeted by the Food and Drugs Administration (FDA) of Maharashtra in initiating enquiries and hygiene checks on grounds that it is selling repackaged goods. The company would present its case in a hearing scheduled on August 8.
More than 200 million Pfizer doses have been administered in the US, and hundreds of millions more worldwide, since December.
US President Barack Obama has signed a historic bill that gives the government powers to curb advertising and promotion of tobacco products.
The source of the synthetic drugs was Asia, especially India and China.
Whistle-blower Dinesh Thakur will speak on Made-in-India drugs at an event in Washington.
The company has been held responsible for the violation of the Drugs and Cosmetic Act, 1940 and the rules framed in 1945.
The Maharashtra Food and Drug Administration has ordered withdrawal of Amulspray from Mumbai with immediate effect.
Wockhardt's US subsidiary, Wockhardt USA, has launched Ondansetron injection in the United States on December 26.
The Food and Drug Administration says all those areas are currently in compliance with blood screening, but that expanded testing is now needed.
The respondents were from over 22 states with 85 percent of them being under 35 years while 61 percent were interns or postgraduate trainees.
After discussion with the Food and Drug Administration (FDA), the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases, the statement said.
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".
Pharma major Ranbaxy Laboratories Ltd on Friday said it has received tentative approval from the US Food and Drug Administration to manufacture and market 25 mg, 100 mg and 200 mg Topiramate tablets.
Wockhardt Ltd said on Thursday it has received approval from USFDA for marketing antibiotic, Clarithromycin tablets, in the US market.
Dr Reddy's Laboratories Ltd on Friday said it has received tentative approval from US Food and Drug Administration for amlodipine besylate tablets.
Agents from the US Food and Drug Administration apparently locked down the US headquarters of the Indian pharmaceutical major as well.
Ranbaxy Laboratories will soon join the select club of Indian pharmaceutical majors and have a share in the $76.6 million generics market for anti-infective Cefprozil tablets in the US.
Maharashtra Food and Drug Administration has prohibited the sales of 'Red Bull', an energy drink, following complaints that the product's main ingredient Taurine is an animal derivative, which the company denies saying it is derived sythetically.
The Food and Drug Administration said its decision is based on new information, including clinical trial data results, that have led it to conclude that the drugs may not be effective to treat COVID-19 and that its potential benefits for such use do not outweigh its known and potential risks.
The alternative, saline implants, rupture too, but such failures are quickly recognised by women as their breasts deflate.
the Maharashtra Food and Drug Administration on Saturday issued directives to various departments to cancel the licences of gutkha manufacturers, wholesalers and retailers in the state after finding magnesium carbonate in gutkha.
The Maharashtra Food and Drug Administration on Monday ordered Parle Bisleri, manufacturer of Bisleri mineral water to stop production in its two units in Mumbai with immediate effect.
There are just 1,500 drug inspectors responsible for more than 10,000 factories in India
More than 44,000 chemists and druggists across Maharashtra will go on a two-day strike on January 11 and 12 to protest the 'draconian' measure by the Food and Drug Administration, which proposed withdrawal of licences in case of any violation.
More than 44,000 chemists and druggists across Maharashtra would go on a two-day strike on January 11 and 12
Wockhardt has received United States Food & Drug Administration approval to market Zonisamide capsules.
