Wednesday, April 1, 2009

Ranbaxy Lab in recovery mode

Ranbaxy Laboratories rose 7.25% to Rs 177.80 at 11:57 IST, extending gains for the second session after the company said its new owner Daiichi Sankyo will meet US drug regulators next month to sort out issues at Ranbaxy's Poanta Sahib plant in India.
The Japanese company made the announcement during market hours yesterday, 31 March 2009, when the stock rose 4.58% to Rs 165.60.
The stock hit a high of Rs 1543.70 and a low of Rs 1497.70 so far during the day. The stock had a 52-week high of Rs 613.70 on 19 June 2008 a 52-week low of Rs 133.15 on 12 March 2009.
India's largest drug maker by sales has an equity capital of Rs 210.18 crore. Face value per share is Rs 5.
Japanese pharma company Daiichi Sankyo, the new owner of Ranbaxy Laboratories will meet US Food and Drugs Administration (FDA) officials next month to sort out the regulatory problems at Ranbaxy's Poanta Sahib plant in India, Daiichi Sankyo's chief Takashi Shoda said on Tuesday, 31 March 2009.
Following an investigation that started in 2006, the US FDA last year banned 30 drugs made by Ranbaxy at Poanta Sahib and Dewas plants from selling in the US. The US regulator, which found Ranbaxy had falsified test results on its drugs, has also halted approval of pending and new marketing applications from the two Indian plants of the company.
Daiichi Sankyo acquired Ranbaxy in November last year, to diversify its business operations into the generic drug and emerging markets.
In a separate development, Daiichi Sankyo and Ranbaxy said on Tuesday that Ranbaxy will market the Japanese company's anti-hypertensive drug, Olvance in India. The two companies have entered into a licensing agreement allowing Ranbaxy to promote and market the drug in India. This is the first product from Daiichi Sankyo's portfolio to be introduced in India through Ranbaxy.
On Monday, 30 March 2009, Ranbaxy had announced winning the US FDA's approval to make and sell topirimate tablets, used for the treatment of seizures. The tablet is a generic version of epilepsy drug Topamax, owned by Ortho-McNeil Pharmaceutical Inc, a unit of Johnson & Johnson.
Ranbaxy, on 23 March 2009, had received good manufacturing practice (GMP) certificates from Medicines and Healthcare products Regulatory Agency (MHRA) of UK and the TGA, Department of Health and Ageing of the Australian Government for its manufacturing facility at Paonta Sahib, Himachal Pradesh, after a joint audit conducted by them in October 2008.
In February 2009, the US FDA halted reviews of drug applications from Paonta Sahib plant saying test results submitted in approved and pending drug applications were found to have been falsified.
On 16 September 2008, the US FDA had issued two warning letters and instituted an Import Alert barring the entry of all finished drug products and active pharmaceutical ingredients from Ranbaxy's Dewas, Paonta Sahib and Batamandi facilities, due to alleged violations of US current Good Manufacturing Practices requirements. That action barred the commercial importation of 30 different generic drugs into the United States and remains in effect.
Ranbaxy Laboratories had on 9 March 2009 received approval from the US FDA to manufacture and market ramipril capsules. Ramipril is used in the treatment of cardiovascular diseases.
Ranbaxy had announced on 6 March 2009, that it had received approval from Australia's drug regulator TGA to market anti-fungal drug Terbinafine. The drug is a generic version of Novartis' Lamisil tablets.
Ranbaxy Laboratories reported a net loss of Rs 806.55 crore in Q4 December 2008 as against a net profit of Rs 48.40 crore in Q4 December 2007. Net sales fell 2% to Rs 1012.72 crore in Q4 December 2008 over Q4 December 2007.
Ranbaxy Laboratories manufactures and markets, generic pharmaceuticals, value added generic pharmaceuticals, branded generics, active pharmaceuticals and intermediates.

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