The United States Food and Drugs Administration has granted Ranbaxy Laboratories a tentative approval to market a generic form of Bristol-Myers' anti-depressant Serzone, US FDA's web site said.
It is now probing the quality of AIDS medicines supplied by the company to developing countries under US government-funded programmes. Estimates suggest that Ranbaxy has received over $9 million from the programme so far. Ranbaxy had a turnover of $1.5 billion in 2007-08, of which a quarter came from US sales.
The United States Food and Drug Administration on Tuesday banned the import of more than 30 generic drugs manufactured by Ranbaxy Laboratories Limited alleging that poor quality control at the firm's factories could be harmful to users of these medications used to treat everything from high cholesterol to Type 2 diabetes to everyday allergies.
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The company has launched the Decitabine for injection in the strength of 50 mg in the US market following approval by the United States Food & Drug Administration of Dr Reddy's abbreviated new drug applications, it said in a statement.
The US Department of Health and Human Services has decided to employ 10 full-time officials in Delhi -- a country director, four drug inspectors, two senior technical experts in medicines, two technical experts in medical devices and one from the food sector. 'The purpose of the appointment is to help develop food and medical product regulations and agencies improve product safety and conduct inspections in a more timely manner,' said Christopher Kelly, press officer, USFDA.
Earlier in April, Sun Pharmaceuticals Industries announced acquisition of Ranbaxy in an all-share deal.
The Ahmedabad-based Claris Lifesciences has received the United States Food & Drug Administration clearance for its sterile injectable manufacturing facility near Ahmedabad.
Over 30 domestic pharmaceutical companies, including Ranbaxy, Cipla, Nicholas Piramal, Zydus Cadila and Torrent, face a possible ban on the sale of the generic version of Merck's pain management drug in the Indian market.
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The company's US subsidiary, Lupin Pharmaceuticals Inc has launched its Ciprofloxacin for oral suspension in the US market in the strengths of 5 g/100 mL (250mg/5 mL) and 10 g/100 mL (500 mg/5 mL), Lupin said in a statement.
Wockhardt's US subsidiary, Wockhardt USA, has launched Ondansetron injection in the United States on December 26.
Wockhardt Ltd said on Thursday it has received approval from USFDA for marketing antibiotic, Clarithromycin tablets, in the US market.
The US-based Dawn Alliance group is planning to set up a United States Food and Drug Administration-approved generic drug manufacturing facility in India.
Cadila Healthcare Ltd has received tentative approval from the USFDA to market Pravastatin Sodium Tablets in the US market.
The United States Food and Drug Administration has given tentative approval to the fixed-dose combination drug products lamivudine and zidovudine tablets -- manufactured by Aurobindo Pharma Ltd.
Wockhardt has received United States Food & Drug Administration approval to market Zonisamide capsules.
Cipla has got tentative approval from the USFDA for its abbreviated new drug application for anti-HIV/AIDS drug Slamivudine.
United States' Food and Drug Administration has granted approval to Ranbaxy Laboratories Ltd to manufacture and market 40 mg capsules of Fluoxetine, a drug used in treatment of obsessive-compulsive disorders.\n\n
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.
The new US bio-terrorism law, which mandates prior registration of food suppliers with the USFDA, is likely to adversely affect the Indian food and marines exports, warns a leading non-government organisation EAN-India.
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.
Ranbaxy Laboratories on Monday said it has received tentative approval from the United States Food and Drug Administration to manufacture and market anti-hypertension drug Quinapril Hydrochloride in the US.
The broader markets ended negatively with mid-caps and small-caps shedding 0.5 per cent on the BSE.
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.
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 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.
JB Chemicals & Pharmaceuticals Ltd on Thursday announced the filing of its first Abbreviated New Drug Application with the United States Food and Drug Administration.
Glenmark Generics Inc USA, the subsidiary of Glenmark Generics Ltd has received nod for it's Hydrocortisone Butyrate Cream USP (0.1 per cent), abbreviated new drug approval from the United States Food and Drug Administration, Glenmark Pharmaceuticals said in a statement.
The company has received final approval for its supplemental New Drug Application (sNDA) for Antara (Fenofibrate) capsules in 30 mg and 90 mg strengths from the United States Food and Drug Administration (USFDA), Lupin Ltd said in a statement.
According to Munjal, there is an opportunity for somebody who comes from a not for profit background in health care to do something.
Top 5 losers include Lupin, Cipla, Sun Pharma, Dr Reddy's Lab and GAIL down 1.6%-11%.
Nestl India is preparing a blueprint for a possible relaunch.
'... And I don't think it really is that despite a lot going wrong.' 'Naiveté or stupidity or trusting the wrong person, the outcome is the same, which is that the group has gone to trash.' 'I'm not OK with people saying I had a role to play in crooking the system, which is not what I did.'
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The company has been reported to be retrenching staff.
The S&P BSE Sensex surged 217 points to end at 25,736.
Financials emerged as the top gainers while auto shares rallied on robust September sales
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Markets ended flat on Tuesday, amid a volatile trading session, as investors exercised caution ahead of the two-day FOMC meet starting today and Reserve Bank of India's monetary policy later this week.
Nifty50 surged 145 points to close at 8,468 after hitting an intra-day high of 8,475.
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