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Another Ranbaxy plant falls foul of FDA

Indian company violates Good Manufacturing Practice

The US Food and Drug Administration (FDA) has found quality deficiencies at another of Ranbaxy's facilities in India, suggesting the company is still struggling to get its manufacturing under control.

In the latest development, the FDA sent Ranbaxy a Form 483 citing violations in Good Manufacturing Practice (GMP) after an inspection of its Toansa active pharmaceutical ingredient (API) manufacturing facility in Punjab.

Six of Ranbaxy's production plants have failed to meet quality requirements in recent years, with four of these - at Mohali, Dewas, Paonta Sahib and Batamandi in India - still operating under an FDA import alert and consent decree that has severely restricted the company's ability to serve the US market.

Towards the end of last year Ranbaxy showed the first signs of a recovery after a US facility - Ohm Laboratories in New Jersey - emerged from a Form 483-prompted enforcement action. Since the import alert was imposed on Mohali last year, Ohm is the only Ranbaxy plant approved to supply oral dosage form products into the US.

The news - along with analyst downgrades - sparked a 10 per cent decline in Ranbaxy's shares on concerns that the continuing negative news flow would add to the FDA's concerns and delay the resolution of the import alert and consent decrees.

Ranbaxy's parent company Daiichi Sankyo said in a statement that the Indian company "continues to improve its systems and processes, and remains fully committed to upholding the highest standards that patients, prescribers, regulators and all other stakeholders expect."

Daiichi Sankyo acquired 60 per cent of Ranbaxy for $4.5bn in 2008, just before the manufacturing problems first emerged, and it seems has started to lose patience with the Indian firm.

Last May, after Ranbaxy was forced to pay $500m in fines and penalties to the US authorities, Daiichi filed a lawsuit against former shareholders in the company saying it had been misled about the extent of the quality deficiencies.

The suit - submitted in Singapore - is seeking redress from former chief executive Malvinder Mohan Singh and Shivinder Mohan Singh, two members of the family that founded Ranbaxy.

The case has since gone to arbitration, and the details of any settlement may not be disclosed unless both parties agree to make them public. The Singhs' position is that Ranbaxy's manufacturing deficiencies were public knowledge when Daiichi entered into the share purchase agreement.

Article by
Phil Taylor

15th January 2014

From: Regulatory



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