Indian drugmaker Ranbaxy Laboratories Ltd has received approval from the US Food and Drug Administration to market an oral suspension form of Warner Chilcott's Duricef antibiotic, the Bombay Stock Exchange
Ranbaxy Laboratories on Monday said it has received final approval from the United States Food and Drugs Administration to manufacture and market Amoxicillin and Clavulnate Potassium tablets, a generic version of GlaxoSmithkline's Augmentin.
Dilip Shanghvi founded Sun Pharma in 1983.
The regulator has given the company 15 days to take corrective measures and report back to it.
Ranbaxy has also agreed to relinquish any 180-day marketing exclusivity that it might have for three pending generic drug applications.
In yet another deadly attack on Indians and Indian-Americans in the United States in recent months, a 34-year-old trained classical dancer from India and a student of Washington University, was shot dead in St Louis, Missouri.
Most of the Kuki MLAs irrespective of their party affiliations are unlikely to attend the Manipur assembly session slated to be called from August 21 in view of the continued ethnic violence, according to leaders from the community.
Gland Pharma, promoted by China's Fosun, has extended its gains, is up 40 per cent since its listing.
In fresh troubles for Nestle over safety standards of its famous Maggi noodle brand, the Uttrakhand Food Safety Department has collected samples of the 'two-minute' noodles from the company's Pantanagar plant and other places in the state.
Charging the multinational companies with making several drugs beyond the reach of the poor, visiting Commerce Minister Anand Sharma today asserted it is the Indian generics which have challenged such a "suffocating stranglehold" and made the medicines affordable.
The letter mentions certain cGMP violation based on site inspections conducted between July and August 2009.
AFI President Adille Sumariwalla raised the possibility of more athletes outside the national camp taking to banned drugs and laid a lot of blame on the district and state level coaches.
Former actress Mamta Kulkarni was on Saturday named as a prime accused in a multi-crore drug racket linked to drug baron Vicky Goswami, with Mumbai police claiming that she was actively involved in the illicit activities and would seek her extradition from Kenya.
Joint Commissioner, Food and Drugs Administration, Pune, had suspended license for its for plants at Ranjangaon and Taregaon after an inspection in May 2009 found that company was using some ingredients which were past their "best before" date.
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.
Despite unprecedented levels of uncertainty in Samvat 2077, investors have little to complain about on the returns front. The BSE Sensex delivered returns of 38 per cent in this period, while the Nifty registered a return of over 40 per cent. As is the case in bull markets, companies in the small- and mid-capitalisation basket outperformed the benchmarks, with returns almost twice those of frontliners.
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 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.
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.
The weakness in the stock was because of inspections by the American drug regulator at its Halol plant in Gujarat which resulted in eight observations, as well as a downward revision of speciality drug payoffs.
The Food and Drug Administration says all those areas are currently in compliance with blood screening, but that expanded testing is now needed.
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.
The company has been held responsible for the violation of the Drugs and Cosmetic Act, 1940 and the rules framed in 1945.
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.
Should Indian cigarette packs also have photos like these to dissuade smokers? Tell us now!
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.
India on Tuesday temporarily licensed the export of paracetamol and anti-malarial drug Hydroxychloroquine in appropriate quantities to some countries, which have been particularly badly affected by the coronavirus pandemic.
After spending considerable time and energy in remediation efforts in the wake of the US Food and Drug Administration's warning letter on compliance issues, the company's leadership has finally set out to bring the house in order.
The Johnson and Johnson vaccine, which works with one dose instead of two, got approval on Saturday, the third vaccine cleared in the country after emergency use authorisation (EUA) was given to two-dose shots from Pfizer and Moderna in December last year.
Recently, Ranbaxy and Wockhardt too were hauled up.
Fund managers said investors remained positive on the pharma manufacturing activity in India, which further strengthened during the Covid-19 period, on account of restrictions imposed on pharma imports from China.
Researchers at Northwell Health in New York are testing the effects on Famotidine (used in high intravenous doses) on Covid-19 patients as a potential treatment. After the hospital announced its clinical trials, it led to a drug shortage in the US. Back home, however, there has not been any surge in the demand for Famotidine yet.
The law bans fruit and spice-flavoured cigarettes, slaps expansive new warnings on packages and gets rid of the monikers 'light' and 'low-tar'.
'WHO issued an emergency use listing for Covovax, expanding the basket of WHO-validated vaccines against COVID-19. The vaccine is produced by the Serum Institute of India under licence from Novavax,' the world health body said in a tweet on Friday.
© 2026 Rediff.com - Advertise with us - Disclaimer - Privacy Policy - Sitemap - Feedback - About us - Terms of use - Grievances