Feb 27, 2009

Ranbaxy tumbles as US FDA says HP plant falsified data

26 Feb 2009 | 10:29 Ranbaxy tumbles as US FDA says HP plant falsified data

Meanwhile, the BSE Sensex was down 64.92 points, or 0.73%, to 8,838.20.

On BSE, 9.25 lakh shares were traded in the counter. The stock had an average daily volume of 4.73 lakh shares in the past one quarter.

The stock hit a high of Rs 204.70 and a low of Rs 176.20 so far during the day. The stock hit a 52-week high of Rs 613.70 on 19 June 2008 and a 52-week low of Rs 161.15 on 23 January 2009.

The large-cap stock had outperformed the market over the past one month till 25 February 2009, gaining 10.53% as compared to the Sensex's rise of 2.63%. However it underperformed the market in the past one quarter, rising 1.79% as compared to the Sensex's 2.38% rise.

The company's current equity is Rs 210.18 crore. Face value per share is Rs 5.

As per reports, an investigation by the US Food and Drug Administration (FDA) has found that Ranbaxy Laboratories had falsified data and test results of medicines manufactured at its Himachal Pradesh (HP) facility to obtain marketing approval in the United States. The FDA disclosure marks completion of the first phase of a probe it had begun soon after Japanese drug major Daiichi Sankyo entered into an agreement with Ranbaxy's promoters in June 2008 to acquire majority shares in the company for over $4 billion.

The FDA said the falsification happened in the case of both approved and pending drug applications. The US drug regulator had stopped all new approvals from the facility in Paonta Sahib, Himachal Pradesh, and had banned the sale of medicines produced from the facility in September 2008.

On 16 September 2008, the 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.

Reports added the US FDA officials have not identified any health risks from Ranbaxy drugs on the market, but were continuing to investigate products associated with the plant.

Meanwhile Ranbaxy before market hours today, 26 February 2009 said it has received a letter from the US drug regulator and added it would continue to cooperate with the US FDA and respond appropriately in a timely manner.

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 adopted a new accounting practice in the December 2008 quarter, which required it account for its forex options, resulting in a foreign exchange-related loss of Rs 784 crore.

Ranbaxy Laboratories is India's largest drug maker by sales. The company manufactures and markets, generic pharmaceuticals, value added generic pharmaceuticals, branded generics, active pharmaceuticals and intermediates.

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