The letter mentions certain cGMP violation based on site inspections conducted between July and August 2009.
Ranbaxy Laboratories has withdrawn all of its generic versions of antiretroviral drugs from World Health Organization's list of approved HIV medicines, saying it's uncertain they are biologically the same as the patented drugs.
Ranbaxy Laboratories Ltd has informed BSE that neither the company nor its UK based subsidiary has received any notice for any civil action in regard to pricing of Penicillin-based drugs in UK.\n\n
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.
Company is among the few companies in the sector getting pulled up by FDA for violations at its factories in India.
The group is looking into a new role for Ranbaxy CEO and MD Arun Sawhney.
Ranbaxy Laboratories has decided to separate the two areas of research and development - drug discovery and generics/NDDS/drug development - to achieve increased focus and rigour for success.
Shares of Ranbaxy Lab and Sun Pharma on Tuesday gained as much as 4 per cent after the drug-makers got CCI's approval for their long-pending $4-billion merger.
Having acquired French company RPG Aventis early this year, Ranbaxy is now eyeing small branded urology molecules in the United States.
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.
Nearly 150 senior management staff will be asked to leave.
USFDA consent decree reveals that firm will have to forego huge short-term opportunities for its generics.
India's leading drug maker Ranbaxy has initiated a voluntary recall of 4,348 cartons of its skin infection drug Sotret (isotretinoin) in the United States. The entire lot pertains to a single batch of tablets which were found to be 'out of specification'.This is the second instance in four months when Ranbaxy has initiated a recall. In July, the company had pulled out a lot of Sotret from the US market after it was found to be degraded.
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.
Singh brothers might be stopped by 'fit & proper' hurdle due to US drug norm violations; firm says confident of qualifying.
Less than three months after roaring into us market with generic for cholesterol-reducing Lipitor, Dept of Justice files for permanent injunction against Ranbaxy.
Sun Pharma open to large acquisitions post Ranbaxy.
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.
Sun Pharma's offer was tempting because Ranbaxy was too busy fighting fires in the US to concentrate on operations.
Pharmaceutical major Ranbaxy Labortaories on Wednesday said it remained confident that its products were safe and effective as the US Department of Justice (DoJ) withdrew a legal motion against it that charged fraudlent practice.
The government on Friday approved the acquisition of drug company Ranbaxy Laboratories by Japanese pharma major Daiichi Sankyo envisaging foreign investment of around Rs 21,500 crore (Rs 215 billion).
"This is the first time in Europe that Daiichi Sankyo and Ranbaxy are leveraging synergies generated through the hybird business model," Ranbaxy Laboratories said.
The joint entity will have a market share of nine per cent in India. Analysts tracking the company said one of the key outcomes of the merger would be to create a single brand entity of Sun and the Ranbaxy brand would eventually dissolve.
Ranbaxy's shares rose by 0.65 per cent on Thursday to close at Rs 493.55 a share, below the offer price of Rs 737 a share. Two days ago, it had been reported that institutional investors Life Insurance Corporation and General Insurance Corporation, which between them hold 16.43 per cent in Ranbaxy, offered to sell their stake.
The company has received a Civil Investigative Demand from the US Department of Justice, Ranbaxy Laboratories said in a filing to the BSE.
Ranbaxy was asked to sell all products containing Leuprorelin which are marketed and supplied under brand name Eligard.
The Securities and Exchange Board of India is looking into the possibility of price manipulation in the shares of Ranbaxy Laboratories. Sources familiar with the developments said a couple of market intermediaries may find the going tough, with the market regulator asking for data on the share price movements before the announcement of Daiichi-Sankyo's acquisition of the Ranbaxy promoters' stake last week.
The initiative will be implemented through the Ranbaxy Community Health Care Society, a non profit organisation established by Ranbaxy, Daiichi and Ranbaxy said in a joint statement.
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.
Pfizer Inc and Ranbaxy Laboratories Ltd on Friday won dismissal of a U.S. antitrust lawsuit accusing them of conspiring to delay sales of generic versions of the best-selling cholesterol drug Lipitor.
Health experts attribute this to the absence of international approval for the drug. About 90 per cent of malaria infections are reported from sub-Saharan Africa.
The 2008 deal agreement contains provisions of arbitration to be held in that country.
It hopes to turn around Ranbaxy within four years of closing the deal by improving efficiency and resolving all regulatory issues
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