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.
If I follow US standards, I will have to shut almost all drug facilities: G N Singh
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.
In keeping with its increased thrust on new markets, Indian pharma major Ranbaxy said on Friday that it has established a subsidiary in Russia with 120 people to begin
Firm pleads guilty to lying to US FDA; says it had set aside the money.
A source said the competition watchdog would by next month suggest 'structural remedies' that included selling key drug segments as conditions for clearing the country's largest pharmaceutical industry merger.
Exports from Ranbaxy plants at Toansa and Dewas to Europe will remain suspended as probes are continuing even as Indian authorities have withdrawn the certification of manufacturing standards from one of the units, European health regulator EMA said today.
Ranbaxy Laboratories on Wednesday said it has received USFDA tentative approval for Sumatriptan Succinate tablets.\n\n
Both companies can now complete the deal.
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.
The comments need to be submitted to the Competition Commission of India within 15 days, along with supporting documents on how the merger can adversely impact the concerned person or entity, the regulator said, while adding that it would not consider 'unsubstantiated objections' to the deal.
The Supreme Court has asked the Andhra Pradesh High Court to take a decision within two days on a plea challenging merger of Sun Pharmaceutical with Ranbaxy.
Ranbaxy Laboratories on Thursday announced that Teva Pharmaceuticals, under a mutual agreement with the Indian pharma major, has commercially launched its Quinapril HCL tablets in the US.
The company has got the approval for the generic version of Roche's anti-viral 'Valcyte', which has a total annual market of around $239 million. Ranbaxy believes that it has First-to-File status on Valganciclovir tablets, thereby, providing a potential of 180-days of marketing exclusivity which offers a significant opportunity in the future, the company said.
India's largest drug maker Ranbaxy Laboratories, which is fighting a patent battle with the world's largest drug maker Pfizer on the cholesterol lowering drug Lipitor in about 18 countries, got a mixed verdict from the Full Court of Federal Court of Australia.
Dinesh Thakur is now planning to start a new venture to help the industry and the US regulator avoid another Ranbaxy-like episode.
The Ranbaxy sale marks the end of a phase for Indian pharma, with the need to evolve the next.
Though independent directors acted in a manner less than desirable, they might not be held responsible.
Ranbaxy Laboratories on Thursday said that it had received final approval from US Food and Drug Administration to manufacture and market Ciprofloxacin.
The company has entered into a tie-up with the US-based FSC Laboratories as its authorised generic partner for FSC's hypertension medicine Isoptin SR (Verapamil SR) in the US.
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.
Ranbaxy Laboratories, India's biggest drugmaker, may lose as much as $140 million of revenue in 2009 after the US drug regulator blocked sale of more than 30 generic medicines and 7 APIs made in two factories of the company, according to analysts.
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 has acquired Be-Tabs Pharmaceuticals, the fifth-largest generics company in South Africa, for $70 million.
Lupin Ltd received marketing approval from the US Food and Drug Administration to market its Cefixime oral suspension drug in the US, Ranbaxy Laboratories has received approval to market two strengths of Cefprozil tablets and Cefprozil powder.
The US Congressional Committee's move to probe approvals by the USFDA of the company's drug is a part of the larger game by an MNC -- 'trying to scuttle its deal with Daiichi Sankyo', Ranbaxy CEO Malvider Mohan Singh said in New Delhi. Recently, the department of justice has filed a motion in the US court against Ranbaxy alleging systematic fraudulent conduct and supplying fabricated information to the USFDA.
Japanese drug-maker Daiichi-Sankyo, which entered into a binding deal with the Ranbaxy Laboratories promoters to buy the latter's 34.8 per cent stake at Rs 737 a share, on Monday said it may revise the open offer price in the case of a competitive bid. The statement assumes significance in the wake of reports that US drug major Pfizer may launch a counter offer for the non-promoter stake of Ranbaxy.
After a detailed scrutiny, fair trade watchdog CCI has suggested Sun Pharma and Ranbaxy to make certain changes in their proposed $4 billion merger deal, including possible divestment of some brands, to address anti-competitive concerns.
Continuing with its push in the US market, Ranbaxy Laboratories said on Monday it has acquired the marketing rights for 13 skincare products from Bristol-Myers Squibb Company for $26 million.
Ranbaxy Laboratories Ltd said on Monday it has entered into a licensing agreement with US-based Gilead Sciences Inc for manufacturing and marketing of Active Pharmaceutical Ingredient and formulations containing anti-HIV drug Tenofovir.
Typically, CCI takes decisions related to M&As within 30 days, though it can do so within 210 days of the filing of application.
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 Laboratories has reached an agreement with GlaxoSmithKline on the litigation over the patent validity of GSK's anti-viral drug Valtrex (Valacyclovir Hydrochloride).
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