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.
Ranbaxy board has approved the hive off of its R&D unit, with an 1:4 share swap ratio.
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.
Typically, CCI takes decisions related to M&As within 30 days, though it can do so within 210 days of the filing of application.
The Competition Commission of India and the US Federal Trade Commission are yet to give their nod to the biggest pharma merger and acquisition deal this year in the Asia-Pacific region.
Ranbaxy's US factory, Ohm Laboratories, is learnt to have got a clean chit from the American regulator. This US facility was under surveillance of the Food and Drug Administration (FDA) since the end of 2012.
US giant expected to bid for 65% non-promoter stake.
The company has launched a new chemical entity Lulifin (Luliconazole) in the Indian dermatology market, the pharma major said in a filing to the Bombay Stock Exchange.
Ranbaxy, originally promoted by the Singh family, was acquired by Japan's Daiichi Sankyo late last year.
An advocate on Wednesday approached the Supreme Court with a PIL seeking cancellation of the license granted to Ranbaxy Laboratories and for initiating probe against the pharma major for allegedly manufacturing and selling adulterated drugs.
The company has received a Civil Investigative Demand from the US Department of Justice, Ranbaxy Laboratories said in a filing to the BSE.
The rupee's appreciation of 6.4 per cent against the dollar and 12 per cent against the euro is likely to hurt the first-quarter performance of the pharmaceutical sector, indicate a results' preview by broking houses.
Global pharma firm AstraZeneca on Tuesday said it had filed a lawsuit in the United States District Court of New Jersey
The challenge of merging Ranbaxy into the company has not been factored in.
Pharma major Ranbaxy Laboratories on Thursday said it has scored a legal victory with a United States court ruling that its Cefuroxime Exetil product does not infringe upon the patent rights of GlaxoSmithKline.
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.
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.
Disappointed with past experience, domestic majors even skip giving any memorandum.
Post Ranbaxy episode, domestic pharma companies may face frequent inspections and deeper scrutiny.
Sun Pharma expects synergy benefits by next fiscal.
In 2014, Sun Pharma agreed to buy Ranbaxy -- which was then controlled by Daiichi.
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
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 FDA actions eventually led to a $500-million fine for Ranbaxy as well as the effective mothballing of many of its Indian factories.
The PIL , filed by advocate M L Sharma, sought action against Ranbaxy for allegedly supplying substandard and adulterated drugs
The Ranbaxy sale marks the end of a phase for Indian pharma, with the need to evolve the next.
Dinesh Thakur is now planning to start a new venture to help the industry and the US regulator avoid another Ranbaxy-like episode.
Company is among the few companies in the sector getting pulled up by FDA for violations at its factories in India.
The company did not comply to the 'good manufacturing practice' norms.
Dinesh Thakur is famous for exposing Ranbaxy safety problems
Sun Pharma has evinced its interest in buying Hyderabad-based biotech company Zenotech Laboratories, through an open offer to buy 28.1 per cent worth Rs 18.41 crore ($3 million).
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