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.
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.
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
Vaccine major Serum Institute of India on Tuesday said the approval for the COVID-19 vaccine 'Covovax' would strengthen immunization initiatives across India and various lower and middle income countries across the world.
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.
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.
Ranbaxy Laboratories Ltd on Tuesday launched its approved generic formulation of Clarithromycin immediate release tablets in the US market.
The tablets are bio equivalent generic version of GlaxoSmithKline's Requip XL tablets
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.
The regulator has given the company 15 days to take corrective measures and report back to it.
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On Oct 14, the Maharashtra unit of FDA had ordered recall of entire stock of Kachha Mango Bite from the marketplace.
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 has also agreed to relinquish any 180-day marketing exclusivity that it might have for three pending generic drug applications.
The US arm of Ranbaxy pleaded guilty to seven felonies relating to the manufacture and distribution of certain adulterated drugs
The letter mentions certain cGMP violation based on site inspections conducted between July and August 2009.
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.
Its factory in Chikalthana in western India was last month hit by the British drug regulator's curb on imports from the plant over manufacturing deficiencies.
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.
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.
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 US health authorities registered more than three times as many new cases as in any previous wave of the coronavirus.
The Maharashtra government has capped the prices of N-95, double and triple layer masks for suppliers and private hospitals in the wake of the Covid-19 pandemic, state health minister Rajesh Tope has said.
The US Food and Drug Administration had in February approved Johnson & Johnson's COVID-19 vaccine that works with just one dose for emergency use.
Company is among the few companies in the sector getting pulled up by FDA for violations at its factories in India.
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 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.
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 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.
Daiichi alleged that Singh brothers had concealed and misrepresented critical information concerning US Food and Drug Administration and Department of Justice investigations into Ranbaxy
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.
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.
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.
