Key Developments: Ranbaxy Laboratories Ltd (RBXZF.PK)
8.45USD
11 Apr 2013
$0.70 (+9.03%)
$7.75
$8.45
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Latest Key Developments (Source: Significant Developments)
Ranbaxy Laboratories Ltd To Pay $500 Million In US Settlement-Reuters
Reuters reported that Ranbaxy Laboratories Ltd pleaded guilty to felony charges related to drug safety and will pay $500 million in civil and criminal fines under the settlement agreement with the U.S. Department of Justice. It includes $150 million in payments for a criminal fine and forfeiture and $350 million in payments for civil claims. Full Article
Daiichi Sankyo Co Ltd and Ranbaxy Laboratories Ltd Launch Hybrid Business in Brazil- Newswire18
Newswire18 reported that Ranbaxy Laboratories Ltd announced that it has launched a hybrid business with Daiichi Sankyo Co Ltd in Brazil to expand business of both companies. Ranbaxy Laboratories will support Daiichi Sankyo's Brazil-based subsidiary, Daiichi Sankyo Brasil Farmaceutica Ltda, to enter the branded generics market in addition to its established business of providing innovative products. Full Article
Ranbaxy Laboratories Ltd Announces Allotment Of Equity Shares
Ranbaxy Laboratories Ltd announced that the Allotment Committee of Directors have allotted 94,136 Equity Shares on exercise of stock options. Full Article
Ranbaxy Laboratories Ltd's Ranbaxy Pharmaceuticals Inc Enters Into In-Licensing Business Agreement With Alembic Pharmaceuticals Limited
Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Ltd announced that it has entered into an in-licensing agreement with Alembic Pharmaceuticals Limited to exclusively market Desvenlafaxine Base Extended Release Tablets in the U.S. healthcare system. Alembic Pharmaceuticals Limited is the sponsor and manufacturer of the New Drug Application (NDA) Desvenlafaxine Base Extended Release Tablets. The product is a bioequivalent version of innovator drug, Pristiq by Pfizer Inc. Desvenlafaxine Base Extended Release Tablets is indicated for the treatment of depressive disorder. The product will be available in 50 mg and 100 mg dosage strengths. Alembic has received the final approval from the US Food and Drug Administration (USFDA) and Ranbaxy expects the product to be available in the U.S. marketplace during the first quarter of 2013. Full Article
Daiichi Sankyo Co Ltd And Ranbaxy Laboratories Ltd Announce Intention To Integrate Business Operations In Thailand
Daiichi Sankyo Co Ltd and Ranbaxy Laboratories Ltd announced their intention to integrate their business operations in Thailand, to leverage and maximize the synergies of the Hybrid Business Model, which is expected to commence business on April 1, 2013. Under this strategy, Daiichi Sankyo and Ranbaxy would integrate the management of Daiichi Sankyo's Thailand subsidiary, Daiichi Sankyo (Thailand) Ltd. (DSTH) and Ranbaxy's Thailand subsidiary, Ranbaxy Unichem Co., Ltd. (RUCL). the new representative of the proposed integrated entity will be, head Suthas Thongprasert, who presently heads DSTH. Full Article
Ranbaxy Laboratories Ltd Halts Generic Lipitor Production After Recall-The Economic Times
The Economic Times reported that Indian generic drug maker Ranbaxy Laboratories Ltd will stop manufacturing version of Pfizer Inc's cholesterol fighter, Lipitor, while it gets to the bottom of the cause of a recent recall, the US Food and Drug Administration. Earlier this month, Ranbaxy recalled certain lots of the widely used cholesterol lowering medicine known generically as atorvastatin at doses of 10 milligrams, 20 mg and 40 mg after the Company discovered contamination with tiny glass particles. There have so far been no reports of patients being harmed due to the glass particulates, the FDA said. The agency said it does not anticipate drug shortages due to the recall as several other companies also produce generic Lipitor, while Pfizer still sells branded version. FDA said it will continue to oversee the recall process and work with the Ranbaxy to resolve pharmaceutical quality issues. Full Article
Ranbaxy Laboratories Ltd Launches Anti-Acne Drug In US Market-The Economic Times
The Economic Times reported that Ranbaxy Laboratories Ltd launched Absorica capsules, used in treating acne, in the US market. Ranbaxy Laboratories Inc (RLI), a wholly owned subsidiary of Ranbaxy Laboratories Ltd announced the launch of Absorica (Isotretinoin) capsules, a product that is licensed from Cipher Pharmaceuticals Inc of Mississauga, Ontario, Ranbaxy said in a statement. Full Article
Ranbaxy Laboratories Ltd's Few Batches Of Generic Lipitor Drug Recalled In United States Of America-Business Standard
Business Standard reported that Ranbaxy Laboratories Ltd voluntarily recalled a few batches of generic Lipitor from the US market. But the Gurgaon-based company is not the only Indian drug maker to voluntarily recall drugs from the US market this year. An enforcement report brought out by the US Food and Drugs Administration (FDA) on November 14 shows Hyderabad-based Aurobindo Pharma voluntarily recalled a batch of Zolpidem drug from the US market in March this year. According to the US FDA enforcement report, the Zolpidem batch was recalled because of adulterated presence of foreign tablets. The FDA enforcement report said, this product is being recalled because 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labelled Zolpidem Tartrate tablets USP 10 mg. Although this is a Class-II recall and not considered very severe, it is significant given the fact that the import of products from the Company’s unit-3 facility were held by this FDA in the past, too, due to packaging discrepancies. US FDA resumed approving products from Aurobindo Pharma’s unit-3 only around June following inspection in March. Full Article
Ranbaxy Laboratories Ltd Launches Generic Version Of Evoxac In US market-The Economic Times
The Economic Times reported that Ranbaxy Laboratories Ltd has launched generic cevimeline hydrochloride capsules, used in treating Sjogren's syndrome, in the US market under an agreement with Daiichi Sankyo Inc. Cevimeline hydrochloride is indicated for the treatment of symptoms of dry mouth associated with Sjogren's syndrome, an autoimmune disorder affecting the moisture-producing glands, and is presently distributed by Daiichi Sankyo Inc under the brand name Evoxac. Full Article
Mylan Inc Sues USFDA For Allowing Ranbaxy Laboratories To Sell Novartis India Ltd.'s Diovan Generic Version-The Economic Times
The Economic Times reported that Mylan Inc has sued the US drug regulator for not allowing it to market a generic version of the Novartis' hypertension medicine Diovan, saying that Ranbaxy Laboratories has lost its exclusivity for the drug as it has failed to get the tentative approval to sell the drug in the US within the specified period. If Mylan Inc succeeds in its appeal, it could wipe off potential one-time revenue of 350-450 crore windfall for Ranbaxy Laboratories. Ranbaxy Laboratories has the exclusive rights to market the generic for 180 days, as it was the first company to successfully challenge Novartis India Ltd' patent for Diovan. The company was scheduled to launch its drug on September 21, the day Diovan's patent expired but is yet to get US Food and Drug Administration's (FDA's) approval. In its lawsuit filed with a federal court in Washington, Mylan Inc argued that Ranbaxy Laboratories forfeited its right to six-month exclusivity to sell the generic drug by not getting FDA's marketing approval, news agency Bloomberg said quoting the Mylan Inc suit. So, FDA's refusal to approve its sale of the drug to the American company is arbitrary and capricious and an abuse of discretion, the report added. Ranbaxy Laboratories failed to receive tentative approval prior to the statutory 30-month forfeiture deadline, and no statutory exception to forfeiture applies, Mylan Inc said in its complaint. Full Article
Ranbaxy shares slump on $500 million fine to settle US drug safety charges
MUMBAI - Ranbaxy Laboratories Ltd shares fell 3.4 percent in pre-open trading on Tuesday after the Indian generic drugmaker pleaded guilty to U.S. felony charges related to drug safety and will pay $500 million in civil and criminal fines.
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