Dr Reddy's Laboratories Limited announced on Thursday that the United States Food and Drug Administration has issued final approval for the company's abbreviated New Drug Application for Ciprofloxacin tablets 100 mg, 250 mg, 500 mg and 750 mg.
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.
More than 200 million Pfizer doses have been administered in the US, and hundreds of millions more worldwide, since December.
A three-member committee, comprising two officials from the Director of Factories and one pharma expert, will probe the gas leak at a production unit of Dr Reddy's Laboratories (DRL). The Director of Factories will appoint a pharma domain expert soon.
Company is among the few companies in the sector getting pulled up by FDA for violations at its factories in India.
Ranbaxy Laboratories on Monday said it has received the US Food and Drug Administration's approval to manufacture and market Isotretinoin capsules, a generic version of Hoffman LaRoche's Accutane.
Daiichi alleged that Singh brothers had concealed and misrepresented critical information concerning US Food and Drug Administration and Department of Justice investigations into Ranbaxy
The US market for the drug is pegged at $1 billion. Cipla has been selling the product in the European market. It had won a similar case in the UK against GSK a couple of years ago.
'Sharapova has been a US resident since early in her career, which does bring in a question of how or why she is using a drug that is not licensed there'
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.
Dr Reddy's Laboratories has filed an Abbreviated New Drug Application with the United States Food and Drug Administration for Levetiracetam tablets, 250, 500 and 750 mg.
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.
Should Indian cigarette packs also have photos like these to dissuade smokers? Tell us now!
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".
Indian drugmaker Dr Reddy's Laboratories hopes to launch two-to-three generic products in the United States this year in a bid to increase its share of a lucrative market, its chief executive said.
The law bans fruit and spice-flavoured cigarettes, slaps expansive new warnings on packages and gets rid of the monikers 'light' and 'low-tar'.
The source of the synthetic drugs was Asia, especially India and China.
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.
Easy access to this kind of test could help people determine what kind of precautions they should take against COVID-19 infection, such as getting an additional booster shot, the researchers said.
Mumbai-based pharma major Lupin will invest over Rs 200 crore (Rs 2 billion) this year to create additional manufacturing capacities.
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.
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.
US President Barack Obama has signed a historic bill that gives the government powers to curb advertising and promotion of tobacco products.
Whistle-blower Dinesh Thakur will speak on Made-in-India drugs at an event in Washington.
The Food and Drug Administration says all those areas are currently in compliance with blood screening, but that expanded testing is now needed.
Wockhardt's US subsidiary, Wockhardt USA, has launched Ondansetron injection in the United States on December 26.
The Maharashtra Food and Drug Administration has ordered withdrawal of Amulspray from Mumbai with immediate effect.
The company has been held responsible for the violation of the Drugs and Cosmetic Act, 1940 and the rules framed in 1945.
India's Directorate General of Foreign Trade on March 25 banned the export of Hydroxychloroquine but said that certain shipments on humanitarian grounds may be allowed on a case-by-case basis. With more than three lakh confirmed cases of coronavirus infection and over 8,000 fatalities, the US has emerged as the worst sufferers of the deadly coronavirus diseases to which there has been no cure.
Wockhardt Ltd said on Thursday it has received approval from USFDA for marketing antibiotic, Clarithromycin tablets, in the US market.
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.
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.
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