Company is among the few companies in the sector getting pulled up by FDA for violations at its factories in India.
All of Ranbaxy's India-based factories are currently banned by the FDA from exporting medicines to the United States, the company's largest market, after the regulator's inspection found violation of its so-called good manufacturing practices.
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plants at Toansa and Dewas to Europe will remain suspended as probes are continuing even as Indian authorities have withdrawn the certification of manufacturing standards from one of the units, European health regulator EMA said today.
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.
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.
Pharma major Ranbaxy Laboratories has set aside Rs 257.4 crore (Rs 2.57 billion) towards the financial impact of a US ban on import of products made at its plant at Toansa.
A day after getting a show-cause notice from the Indian regulator, senior executives from Ranbaxy Laboratories approached the drug controller's office on Tuesday afternoon, it was learnt.
The Gurgaon-headquartered drug maker, set to be acquired by another leading domestic company, Sun Pharmaceutical Industries, reported a consolidated net loss of Rs 186 crore for the quarter ended June.
The move follows an FDA inspection of a Ranbaxy facility which identified significant violations of sound manufacturing practices.
Yet another factory of Ranbaxy, this time in Toansa (Punjab), has been banned from selling in the United States. Once again the company faces charges of unclean manufacturing practices.
Ranbaxy Laboratories is recalling 29,790 blister packs of anti-allergy drug in the US, manufactured by its arm Ohms Laboratories, due to defective packaging.
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.
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Tech Mahindra and United Spirits will replace them in the 50-share index of the National Stock Exchange with effect from March 28.
The recalled drugs were manufactured and distributed in the US by Ohm Laboratories.
India on Monday raised serious concerns over the USFDA's audit inspections of Indian pharma companies and 'disproportionate penalties' in some instances and said it would submit a discussion document on the issues to the US.
Sun Pharma's offer was tempting because Ranbaxy was too busy fighting fires in the US to concentrate on operations.
4 Ranbaxy facilities in India have been barred from exporting to US.
In 2014, Sun Pharma agreed to buy Ranbaxy -- which was then controlled by Daiichi.
The company buys distressed assets across the globe and turns them around to not only add to its books but also its product pipeline and regions.
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.
The PIL , filed by advocate M L Sharma, sought action against Ranbaxy for allegedly supplying substandard and adulterated drugs
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.
In 2013, Daiichi had launched the arbitration proceedings in Singapore.
The recall is the latest in a series of problems to hit Ranbaxy, which has had all its India factories stopped from sending drugs and ingredients to the United States.
Sun Pharma expects synergy benefits by next fiscal.
Over-expansion, bad management, and multiple allegations irreparably taint Malvinder and Shivinder Singh
The Halol facility is important for the company as it accounts for 10 per cent of Sun Pharma's sales.
The FDA actions eventually led to a $500-million fine for Ranbaxy as well as the effective mothballing of many of its Indian factories.
Details on prices sought as 10 generic drugs become up to 83 times costlier in 6 months
There are just 1,500 drug inspectors responsible for more than 10,000 factories in India
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