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.
Pharmaceutical giant Ranbaxy on Monday said that it has received tentative approval from the US Food and Drug Administration to manufacture and market carvedilol tablets for treatment of cardiac disorders including hypertension.\n\n\n\n
Ranbaxy Laboratories has received tentative approval form the Food & Drug Administration USA for manufacturing and marketing Fluconazole tablets
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 company was indicted for violations at one of its US facilities in 2009, even after Daiichi Sankyo took over as majority shareholder in 2008.
In a major boost to Ranbaxy Laboratories' exports to developed countries, the United States has approved marketing of flecainide acetate tablets in the country.
Regulator says fee would enable it to quicken approval process.
The US Congressional committee, which is inquiring into the country's Food and Drug Administration's handling of drug-marketing approvals of India's leading drug-maker Ranbaxy, has extended its probe into similar permissions given to Iceland's Actavis.
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 on Friday said it has received tentative approval from US Food and Drug Administration to manufacture and market Ofloxacin, the generic version of Ortho Mcneil Pharmaceutical Inc's Floxin.
Shares of Ranbaxy Laboratories on Friday slumped as much as 20 per cent in the morning trade after the USFDA prohibited the company from producing and distributing drugs for the American market from its Toansa plant in Punjab.
All of Ranbaxy's India-based factories are currently banned by the FDA from exporting medicines to the United States, the company's largest market, after the regulator's inspection found violation of its so-called good manufacturing practices.
This move could cost $299 million a year for Indian pharma players.
Whistle-blower Dinesh Thakur tells briefing on US Capitol Hill: 'One in five medicines manufactured and distributed in India are spurious.' Aziz Haniffa reports from Washington, DC.
The case was earlier heard by a different vacation bench which had on June 10 asked Sharma to substantiate his 'unfounded allegations' that the Indian pharma major was allegedly manufacturing and selling adulterated medicines.
Sun Pharma to retain these in most markets; US could be the exception, where the Ranbaxy name has taken a hit.
The recalled drugs were manufactured and distributed in the US by Ohm Laboratories.
Agents from the US Food and Drug Administration apparently locked down the US headquarters of the Indian pharmaceutical major as well.
Under terms of the agreed deal, Ranbaxy shareholders will get 0.8 of a Sun Pharmaceutical share for each Ranbaxy share they own.
US District Judge Beryl Howell in Minneapolis denied Ranbaxy's request, the court filing showed.
While the US health regulator did not specify details for issuing the alert, it said 'detention without physical examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices'.
It had posted net profit of Rs 125.75 crore (Rs 1.25 billion) during the January-March quarter of the previous fiscal, 2012-13.
Slapped with Rs 242-crore fine by US authorities for rule violations at Toansa unit, say sources; 2nd such hefty rap in the recent past from US regulators for bending rules.
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The company has been reported to be retrenching staff.
In comparison, Indian companies received only 23 out of 139 final approvals (16.54 per cent) in the corresponding period in 2006.
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
The Supreme Court on Monday posed some tough questions to a lawyer, asking him to substantiate his "unfounded allegations" in a PIL that Indian pharma major Ranbaxy Laboratories Ltd was allegedly manufacturing and selling adulterated medicines.
Ohm Laboratories Inc, a wholly-owned subsidiary of Ranbaxy has received approval from the US Food and Drug Administration for manufacturing and marketing Valsartan tablets in strengths of 40 mg, 80 mg, 160 mg, and 320 mg on an exclusive basis, Ranbaxy Laboratories said in a statement.
Sun Pharma open to large acquisitions post Ranbaxy.
The FDA actions eventually led to a $500-million fine for Ranbaxy as well as the effective mothballing of many of its Indian factories.
FDA inspectors visited the Mohali plant in the process of giving approval to Ranbaxy's application for Valsartan.
Last year, Ranbaxy had paid around $4,20,000 to the US state of Idaho as part of a $500-million settlement that the drug firm had signed with US authorities.
In May this year, Ranbaxy had pleaded guilty to 'felony charges' for violating manufacturing norms and agreed to pay $500 million penalty to US authorities.
The company buys distressed assets across the globe and turns them around to not only add to its books but also its product pipeline and regions.
The recall is the latest in a series of problems to hit Ranbaxy, which has had all its India factories stopped from sending drugs and ingredients to the United States.
Pharma major Ranbaxy Laboratories has set aside Rs 257.4 crore (Rs 2.57 billion) towards the financial impact of a US ban on import of products made at its plant at Toansa.
Whistle-blower Dinesh Thakur will speak on Made-in-India drugs at an event in Washington.
