Indian drug major Ranbaxy Laboratories has got the US Food and Drug Administration nod for the manufacture and sale of Ofloxacin tablets.
Ranbaxy Laboratories on Thursday said it had received Abbreviated New Drug Application approval from the US Food and Drug Administration to manufacture and market Loratidine
Ranbaxy Laboratories Ltd on Friday said it has received approval from the US Food and Drug Administration to manufacture and market multiple dosages of anti-diabetes drug Glimepiride tablets.
These brands belong to about 320 drugs of leading Indian pharmaceutical companies. The Drug Controller General of India's (DCGI's) office feels that these have been launched without its approval.
In a setback that could potentially delay the launch of Bharat Biotech's Covid-19 vaccine Covaxin in USA, the Food and Drug Administration there has "recommended" Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation.
Wockhardt Ltd said on Tuesday it has got US Food and Drug Administration's approval to market painkiller tablets containing a combination of Dextropropoxyphene napsylate and Acetaminophen in the US market.
The 2008 deal agreement contains provisions of arbitration to be held in that country.
All medicines that have USFDA approvals continue to be produced in the Poanta Sahib facility. The USFDA has not given any approval for new drugs as they have some concerns. We are addressing them, Malvinder Singh said.
In a shocker, the US Food and Drug Administration has discovered the presence of mice, ants and cockroaches in food served on airlines in the country.
Through a Freedom of Information Act request, the Show '20/20' obtained lists of recent health violation records from the FDA, the agency in charge of inspecting airlines and their outside food caterers.
A popular energy drink, produced by a company founded by an Indian-American billionaire, has come under the scanner in the United States after reports of 13 deaths possibly linked to the energy shots.
The FDA Commissioner Margaret Hamburg is slated to travel to India soon.
Company is among the few companies in the sector getting pulled up by FDA for violations at its factories in India.
The company has already received approval from the US Food & Drug Administration for marketing clarithromycin tablets.
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.
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.
The surprising part was that seven of his personal security officers were youngsters, who had joined his drug de-addiction centre for rehabilitation, the officials said, adding that during their stay there for treatment they had been imparted training.
Drugmaker Dr Reddy's Laboratories has filed an application with the US Food and Drug Administration to market a generic form of Eli Lilly's schizophrenia drug Olanzapine in the US
'Almost 60 per cent of 2,000 songs had references to drugs and violence.'
Australian sports administrators responded angrily to a government report saying doping was widespread among professional and amateur athletes and demanded investigators name offenders to protect clean athletes' reputations.
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
In a major boost to Ranbaxy Laboratories' exports to developed countries, the United States has approved marketing of flecainide acetate tablets in the country.
A Russian court on Tuesday dismissed US WNBA basketball star Brittney Griner's appeal against a nine-year sentence for possessing and smuggling vape cartridges containing cannabis oil, paving the way for her to be sent to a penal colony, in a court case that Washington has called "sham".
As the pandemic spreads and the urgency for effective treatment of COVID-19 mounts, several countries, including the US, have started relying heavily on HCQ, majorly used in the treatment of malaria and rheumatoid-arthritis.
Maggi has also come on the radar of US Food and Drug Administration.
In a setback to pharmaceutical major Ranbaxy Laboratories Ltd, the US drug regulator USFDA has directed the company to recall as many as 7.32 crore (73.2 million) Gabapentin tablets of 600 and 800 mg strengths.
The tablets are bio equivalent generic version of GlaxoSmithKline's Requip XL tablets
Ranbaxy Laboratories has received tentative approval form the Food & Drug Administration USA for manufacturing and marketing Fluconazole tablets
Insiders who have 'privileged' access to the right information make the gains, while the ordinary investor is left holding overvalued stocks. Here's help to avoid that trap
Indian drugmaker Morepen Laboratories Ltd has filed an international patent for the manufacturing process of Desloratadine, the Bombay Stock Exchange said on Wednesday.
Ranbaxy Laboratories on Friday said it had received the United States Food and Drug Administration approval to manufacture and market Metformin HCL oral solution, a drug used by the diabetic patients.
On Oct 14, the Maharashtra unit of FDA had ordered recall of entire stock of Kachha Mango Bite from the marketplace.
Ranbaxy Laboratories Ltd on Tuesday launched its approved generic formulation of Clarithromycin immediate release tablets in the US market.
The Bombay high court on Wednesday permitted Johnson & Johnson to manufacture, sell and distribute its baby powder and quashed three orders of the Maharashtra government revoking the company's license and asking it to stop the product manufacture and sale, terming them as "stringent, unreasonable and unfair". A division bench of Justices Gautam Patel and S G Dige also came down heavily on the state Food and Drug Administration (FDA) for its delay in carrying out tests on a sample of the company's baby powder seized in December 2018. The bench noted that while maintaining standards of quality and safety are of utmost importance for cosmetic products, at the same time it does not seem reasonable to shut down the whole manufacturing process when there is a slight deviation in one of the products.
Daiichi alleged that Singh brothers had concealed and misrepresented critical information concerning US Food and Drug Administration and Department of Justice investigations into Ranbaxy
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