Ranbaxy Laboratories Ltd said on Thursday that it has bagged the US Food and Drug Administration's approval for manufacturing and marketing Loratadine and Pseudoephedrine Sulfate Extended-release tablets.
Ranbaxy Laboratories has received approval from the U.S. Food and Drug Administration to manufacture and market Clarithromycin XL 1,000 mg tablets.
India's largest drug manufacturer, Ranbaxy Laboratories, had falsified data and test results of medicines manufactured at its Himachal Pradesh facility to obtain marketing approval in the United States, says the US Food and Drug Administration.
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.
At present, there is no provision under Drugs Rules, 1945 to address issues of wrong information to obtain regulatory approvals.
Drug-maker Ranbaxy Laboratories on Thursday said it has received the US health regulator's approval to market Quinapril Hydrochloride and Hydrochlorothiazide tablets, used in treatment of high blood pressure, in different strengths in America.
The drug is licensed to Ranbaxy Laboratories from Cipher Pharmaceuticals Inc of Mississauga, Ontario. It is currently protected by two issued patents listed in the FDA's approved drug products list, which expire in September 2021, the company said in a statement.
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
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.
Ranbaxy on Tuesday announced it had got final approval from the US Food and Drug Administration to market its Metformin HC1 tablets for diabetes.
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.
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.
Earlier, Jaslok Hospital had issued an advisory to its doctors to avoid prescribing drugs manufactured by Ranbaxy.
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.
Ranbaxy Laboratories Ltd has received the US Food and Drug Administration approval to market Fosinopril sodium tablets in the United States.
Ranbaxy Laboratories Ltd today said it has received tentative approval from the US Food and Drug Administration to manufacture and market Glimepiride tablets of 1 mg, 2 mg, 4 mg and 8 mg.
Ranbaxy Laboratories on Thursday said that it had received final approval from US Food and Drug Administration to manufacture and market Ciprofloxacin.
Earlier in April, Sun Pharmaceuticals Industries announced acquisition of Ranbaxy in an all-share deal.
The firm, however, said the anti-cholesterol tablets meant for the US market will be produced at its Mohali SEZ plant in Punjab and not at the three units banned by the US health regulator.
The company has received a Civil Investigative Demand from the US Department of Justice, Ranbaxy Laboratories said in a filing to the BSE.
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.
Ranbaxy Laboratories on Tuesday said it had received approval from US Food and Drug Administration to market a semi synthetic cephalosporin Panixine DisperDose, a generic version of Ceph International Corp, Keflex.
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As per the media report, the US Food and Drug Administration is learnt to have issued a Form 483 to the company's manufacturing facility at Mohali a few months ago after finding deviations from norms during an inspection of the plant.
Ranbaxy Laboratories is recalling 29,790 blister packs of anti-allergy drug in the US, manufactured by its arm Ohms Laboratories, due to defective packaging.
Ranbaxy drugs sold in the United States will be gradually rebranded as Sun Pharma treatments
FDA had cancelled Ranbaxy's approvals to launch generic Nexium, Valcyte
Ranbaxy has acceded to the request of Health Canada to quarantine drugs produced from its Paonta Sahib facility at Himachal Pradesh, North American country's newspapers reported, highlighting the trouble in store for the Japanese-controlled drug maker. Health Canada is a department of the government of Canada with responsibility for national public health.
FDA allows Teva to launch Nexium generic; Cipla, which supplies formulation, to gain
Australian health regulator Therapeutic Goods Administration is investigating Indian pharma major Ranbaxy, following US allegations of the company falsifying data and test results of new drug applications, a media report says.
Patient safety and quality our guidance now, says CEO and MD Arun Sawhney.
In addition to the US drug regulator, Food and Drug Administration, and rival pharma majors that appear keen to launch litigation against Indian company Ranbaxy, a US citizen has joined the bandwagon by filing a case in the world's biggest drug market.
PPD Inc has acquired exclusive worldwide license to develop, manufacture and market Ranbaxy's cholesterol lowering novel statin.
Ranbaxy's shares jumped almost 10 per cent, having long been depressed by escalating investigations from the US Food and Drug Administration, triggering a ban, which is still in place, that stops the US importing or purchasing the company's drugs. Daiichi Sankyo, the Japanese drugmaker, reiterated on Wednesday that it would stick to its June offer to buy Ranbaxy in spite of its recent troubles.
A day after getting a show-cause notice from the Indian regulator, senior executives from Ranbaxy Laboratories approached the drug controller's office on Tuesday afternoon, it was learnt.
USFDA consent decree reveals that firm will have to forego huge short-term opportunities for its generics.
The move follows an FDA inspection of a Ranbaxy facility which identified significant violations of sound manufacturing practices.
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
Sanjeev Dani, senior vice-president and regional director, Asia and CIS, Ranbaxy, said, "We are pleased to partner with Sirtex. We shall work towards creating a productive relationship."
