Teva Women's Health filed a suit this week in the US District Court for New Jersey, claiming that Lupin had filed an abbreviated new drug application with the US Food and Drug Administration, which infringes the patents of Seasonale, its oral contraceptive that limits the number of menstrual periods women have in a year.
If Taro fails to address the issues raised by the US Food and Drug Administration, it may face ban on many of its products in the US market, made from the facility at Ontorio, Canada. If Taro fails to address the issues raised by the US Food and Drug Administration, it may face ban on many of its products in the US market, made from the facility at Ontorio, Canada. If Taro fails to address the issues raised by the US FDA, it may face ban on many of its products.
The US Food and Drug Administration has tightened rules for selling dietary supplements in the US market, making compliance with current good manufacturing practices mandatory for manufacturers.
The US vice-president-elect received a dose of the Moderna vaccine from clinical nurse Patricia Cummings at United Medical Center, which is located in Southeast Washington, DC.
US President Barack Obama has signed a historic bill that gives the government powers to curb advertising and promotion of tobacco products.
Serum Institute has the capacity to make 250 million doses of Covishield monthly.
PPD Inc has acquired exclusive worldwide license to develop, manufacture and market Ranbaxy's cholesterol lowering novel statin.
The Rs 1,027-crore (Rs 10.27 billion) company has filed 13 abbreviated new drug applications and 22 drug master files with the US Food and Drug Administration and regulatory agencies in Europe for supply of formulations and active pharmaceutical ingredients. Some of the ANDAs challenge innovator patents and the company's strategy will be to partner with established companies in the US and Europe for marketing formulations, said Pranav Amin, director, Alembic.
Ranbaxy Pharmaceuticals Inc said on Tuesday it has received US Food and Drug Administration's approval for manufacturing and marketing cardiovascular drug -- Atenolol tablets in the US.
Amid reports of a US Congress probe against India's largest drug maker Ranbaxy Laboratories, data show that many leading multinational companies such as Pfizer, GlaxoSmithKline, Novartis and Merck are also under the scanner of the US drug regulator, for more or less similar violations as Ranbaxy is alleged to have committed.
Last year, the USFDA had banned 30 generic drugs produced at Ranbaxy's plants at Poanta Sahib.
Mumbai-based pharma major Lupin will invest over Rs 200 crore (Rs 2 billion) this year to create additional manufacturing capacities.
RPG Life already has marketing tie-ups with Israel's drug major Teva for the EU market and with the US-based Apotex for the Canadian market.
The Finland-based drug major Orion Corporation has filed a lawsuit in the United States against domestic drug major Wockhardt for challenging the patents on its brand Stalevo, used for the treatment of Parkinson's disease.
Ranbaxy Laboratories, Dr Reddy's Laboratories and Sun Pharma's US subsidiary Caraco Pharmaceuticals are among the 13 generic manufacturers to get first generic approvals from the US Food and Drug Administration to manufacture and market generic versi
Sources say FDA letter over product and not entire facility
Eli Lilly and Company, the US-based multinational pharmaceutical major, has sued Sun Pharmaceuticals in the US, alleging the company infringed its patent on Gemzar, a blockbuster cancer drug.
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.
GlaxoSmithKline has filed a lawsuit in a United States court against Dr Reddy's Laboratories alleging infringement of patent rights of a generic version of 'Imitrex' drug, used for the treatment of migraine.
The Indian pharmaceutical companies are involved in patent litigations of a mere 40 drugs, out of the 135 known patent litigation drugs in the US. This is despite the claims by major Indian players such as Ranbaxy and Dr Reddy's at having secured over 20 first to file status abbreviated new drug applications with the US Food and Drug Administration.
Two United States senators have asked the US Food and Drug Administration (USFDA) to provide details of market approvals given to all medicines sold by India's largest drug-maker Ranbaxy 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.
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 identification of host dependency factors mediating virus infection may provide key insights into effective molecular targets for developing broadly acting antiviral therapeutics against SARS-CoV-2 and other deadly coronavirus strains, according to the researchers.
In comparison, Indian companies received only 23 out of 139 final approvals (16.54 per cent) in the corresponding period in 2006.
Dr Reddy's Laboratories Ltd on Friday said it has received tentative approval from US Food and Drug Administration for amlodipine besylate tablets.
Indian women may consider it sacred to adorn 'Sindoor' (vermilion) on their foreheads, but the United States government has warned against using a particular brand of this toxic 'red powder' due to high lead content.
Ranbaxy Laboratories on Friday said it had received approval from US Food and Drug Administration to manufacture and market nitrofurantoin monohydrate macrocrystals capsules (100 mg) and planned to bring the new drug to the market in April.
Agents from the US Food and Drug Administration apparently locked down the US headquarters of the Indian pharmaceutical major as well.
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.
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 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.
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.
Ranbaxy Laboratories has received tentative approval from the US Food and Drug Administration to manufacture and market Fosinopril Sodium and Hydrochlorothiazide tablets in 10 mg/12.5 mg and 20 mg/12.5 mg strengths
Illustrious international thinkers met at the Milken Institute Global Conference 2021 and many discussions addressed the impact of the COVID-19 pandemic on the world at large.
Sun Pharma Ltd has received tentative approval for cancer drug Ondansetron from US Food and Drug Administration.
Ranbaxy Laboratories has received tentative approval from the US Food and Drug Administration to manufacture and market Lamivudine Tablets in 150 mg strength, the company announced on Saturday.
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