The company has already received approval from the US Food & Drug Administration for marketing clarithromycin tablets.
Ranbaxy Laboratories has received tentative approval form the Food & Drug Administration USA for manufacturing and marketing Fluconazole tablets
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.
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 2008 deal agreement contains provisions of arbitration to be held in that country.
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
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
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 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.
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.
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.
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.
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 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.
Company is among the few companies in the sector getting pulled up by FDA for violations at its factories in India.
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.
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.
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 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.
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.
