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.
Continuing its expansion in Europe, Ranbaxy Laboratories Ltd on Tuesday said it has entered into the Italian pharmaceutical market with the launch of a wholly owned subsidiary, Ranbaxy Italia SPA, in Milan.\n\n
Pfizer, the world's largest drug company, and Wyeth have sued Daiichi Sankyo-owned Ranbaxy Laboratories in a US court for infringing the patent rights of Wyeth's drug, Rapamune.
Ranbaxy Laboratories will file an appeal against a New Jersey district court order restraining Teva Pharmaceuticals and Ranbaxy Pharmaceuticals Inc from selling RPI's quinapril tablets (5, 10, 20, and 40 mg) on a challenge filed by Pfizer.
The launch came after final approval from the US health regulator to manufacture the generic version of Lipitor at Ranbaxy's wholly owned Ohm Laboratories facility in New Brunswick, New Jersey, as well as market the product.
The Canadian health and drug regulator Health Canada has asked Ranbaxy Pharmaceuticals Canada (RPCI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL) to withdraw its generic, 25 microgram per hour strength, fentanyl pain-relief patches from the Canadian market due to safety concerns.
The company had stopped production of generic version of cholesterol lowering drug Lipitor last year as it investigated the issue of potential glass particles in certain lots of the drug.
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 said on Monday that it has received tentative approval from the US Food and Drug Administration to manufacture and market Modafinil tablets, a generic of Cepahalon's Provigil.
US-based Purdue Pharma has filed a patent infringement suit against India's largest drug company, Ranbaxy, after the latter's wholly-owned US subsidiary, Ranbaxy Pharmaceuticals Inc, applied for marketing approval of a low-cost version of Purdue's pain relieving medicine, Oxycodone.
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
The company's Canadian subsidiary Ranbaxy Pharmaceuticals -- Canada Inc has received final approval from TPD to manufacture and market Ran-Simvastatin tablets, the Gurgaon-headquartered pharma major said in a statement. The approval for Ran-Simvastatin tablets, which are used as a lipid metabolism regulator, is in the strength of 5, 10, 20, 40 and 80 mg.
Ranbaxy Laboratories on Thursday said that it had received final approval from US Food and Drug Administration to manufacture and market Ciprofloxacin.
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 Laboratories on Monday said it has received the US Food and Drug Administration's approval to manufacture and market Isotretinoin capsules, a generic version of Hoffman LaRoche's Accutane.
Ranbaxy, its partners and Actavis have signed a non-exclusive agreement.
According to analysts, Indian drug makers are forging alliances with overseas companies such as CD Pharma, Gnosis SpA, Crawford Healthcare and Syrio Pharma to sell drugs for chronic and acute cases. According to analysts, Indian drug makers are forging alliances with overseas companies such as CD Pharma, Gnosis SpA, Crawford Healthcare and Syrio Pharma to sell drugs for chronic and acute cases.
The proposed merger would likely harm future competition
Under terms of the agreed deal, Ranbaxy shareholders will get 0.8 of a Sun Pharmaceutical share for each Ranbaxy share they own.
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 move follows an FDA inspection of a Ranbaxy facility which identified significant violations of sound manufacturing practices.
Almost a year after announcing a $4 billion deal, Sun Pharmaceutical Industries on Tuesday said merger of Ranbaxy with itself has been 'consummated.'
Ranbaxy Ghuangzhou China is a joint venture formed in 1993 between the Ranbaxy group, Guangzhou Baiyunshan Pharmaceutical Company Ltd, China and Hong Kong New Chemic.
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.
Last year, Ranbaxy had to pay a fine of $500 million to the US authorities after it pleaded guilty to fraudulent activities and misrepresenting data to seek fast approvals.
"We are responding to all queries from US FDA and will emerge as a stronger player in the world's biggest pharmaceutical market," Ranbaxy Chairman and Managing Director Malvinder Singh said. The US, which accounts for 20 per cent of Ranbaxy's $1.5-billion annual turnover, has an import restriction on 30 of its medicines by the US Food and Drugs Authority.
On January 31, the US Federal Trade Commission cleared the merger.
Sun Pharma open to large acquisitions post Ranbaxy.
Sun Pharma's offer was tempting because Ranbaxy was too busy fighting fires in the US to concentrate on operations.
While Watson is a near comparable to Ranbaxy in terms of the generics business in the US, on margins and capital efficiency front, Ranbaxy is way ahead of Watson.
Privately held Solrex has acquired an 11.4 per cent stake in Chennai-based Orchid, a bulk drugs and formulations maker, in just two weeks. Deputy MD says Solrex is linked to Ranbaxy, but stake buy isn't a takeover attempt. Orchid shares have doubled in recent weeks amid Solrex's buying and speculation it was linked to Ranbaxy & was preparing a takeover. A Ranbaxy spokesman has said the company did not believe in hostile takeovers. Orchid has launched a unit in Japan recently.
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