Sun Pharmaceutical Industries will take a call on whether to shut Ranbaxy's troubled factories or make changes in the top management of the latter only after its $4-billion acquisition deal is complete.
The drug is licensed to Ranbaxy Laboratories from Cipher Pharmaceuticals Inc of Mississauga, Ontario. It is currently protected by two issued patents listed in the FDA's approved drug products list, which expire in September 2021, the company said in a statement.
Both companies can now complete the deal.
The investment has lost almost 40 percent of its value in six years.
Sun maintained it would retain the best of both organisations to build a global pharma company.
Competition watchdog says 'high market concentration' in some segments a worry.
The voluntary move comes a little more than a year after the Central Drugs Standard Control Organisation, the central authority that approves new drugs for marketing, had asked the drug makers to withdraw the 'combination drugs' as they are 'unnecessary' and may pose health hazards. The Drugs Controller General of India had banned 294 combination drugs sold under nearly 1,053 brand names from the market in June 2007.
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.
Ranbaxy Laboratories on Friday said it has received tentative approval from US Food and Drug Administration to manufacture and market Ofloxacin, the generic version of Ortho Mcneil Pharmaceutical Inc's Floxin.
In 2014, Sun Pharma agreed to buy Ranbaxy -- which was then controlled by Daiichi.
Sun Pharma would have to do a lot of work to get USFDA to revoke the ban on Ranbaxy facilities but it has not put any time-frame for this, company ChairmanIsrael Makov said.
Torrent to buy Ranbaxy's anti-bacterial generic
US-based Abbott Laboratories has sued Sun Pharmaceutical Industries and Ranbaxy Laboratories in courts there for challenging the patents of its cholesterol-lowering drugs, Niaspan and TriCor, respectively, in separate infringement suits.
The FDA actions eventually led to a $500-million fine for Ranbaxy as well as the effective mothballing of many of its Indian factories.
In a setback to pharmaceutical major Ranbaxy Laboratories Ltd, the US drug regulator USFDA has directed the company to recall as many as 7.32 crore (73.2 million) Gabapentin tablets of 600 and 800 mg strengths.
Based on a writ petition filed by some individual investors, the High Court while ordering the status quo on Friday, issued notices to SEBI, BSE, NSE, Sun Pharma, Ranbaxy, Daichii Sankyo and Silver Street Developers.
Malvinder steps down as CMD four years ahead of schedule.
Sun Pharmaceutical Industries reported a 34 per cent year-on-year (Y-o-Y) jump in net profit to Rs 2,654.6 crore in Q4FY24.
Pharmaceutical giant Ranbaxy on Monday said that it has received tentative approval from the US Food and Drug Administration to manufacture and market carvedilol tablets for treatment of cardiac disorders including hypertension.\n\n\n\n
The capital market regulator has to recover Rs 64.85 lakh (Rs 6.48 million) from Ranbaxy's former independent director V K Kaul and Rs 12.97 lakh (Rs 1.29 million) from his wife Bala Kaul.
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According to information available on the European Commission website, Ranbaxy Laboratories has been fined euro 10.32 million (over Rs 80 crore).
In 2013, Daiichi had launched the arbitration proceedings in Singapore.
FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.
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.
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.
The Ranbaxy experience has made multinational corporations more cautious about Indian acquisitions in general
K Raghavendra Rao, one of the founding promoters and managing director of Orchid Chemicals and Pharmaceuticals, said he may initiate talks to buy back its 14.7 per cent stake that is now with Rexcel, a unit of pharma major Ranbaxy.
Agents from the US Food and Drug Administration apparently locked down the US headquarters of the Indian pharmaceutical major as well.
Domestic pharma giant Ranbaxy Laboratories Limited has topped the list of patent filers in the area of drug applications from the Third World countries last year with 64 new formulations.\n\n\n\n
The stock faced similar trends on the National Stock Exchange as well, where it opened at Rs 362, then plunged 2.70 per cent to an early low of Rs 354.10.
Pharmaceutical major Ranbaxy Laboratories on Wednesday said it was confident of clocking around 23 per cent growth in global sales in 2003.
Experts said it is the first time that an Indian pharmaceutical company has been charged with such serious offences, and that the firm may be prosecuted if the allegations are proved. Able Labs of the US, now a unit of Sun Pharma through an acquisition in 2005, had to face similar charges in 2004-2005.
Ranbaxy Laboratories on Wednesday reported widening of its consolidated net loss to Rs 1,029.72 crore (Rs 10.29 billion) for the third quarter ended December 31, 2014
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.
Currency values were the bigger villain over the 7 years
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