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Daiichi, Ranbaxy form team to face FDA charges news
27 February 2009

Daiichi Sankyo, the new owner of India's largest drugmaker Ranbaxy Laboratories, said it has 'formed a team' to solve the issues raised after the US Food and Drug Administration accused Ranbaxy of falsifying data and test results of over two dozen drugs made in its Poanta Sahib plant in Himachal Pradesh, and said it would halt approval of pending and new drugs from the plant.

The FDA has stopped granting approval to the sale of medicines produced in the facility since September 2008 pending investigation. The agency suspended the evaluations after findings at the facility raised ''significant questions about the reliability'' of data used to support requests to sell drugs in the US, the regulator said.

A Daiichi Sankyo statement said the company takes the issue very seriously. ''Both Daiichi and Ranbaxy have already formed a team to solve the issue,'' it said.

Referring to the Abbreviated New Drug Applications (ANDAs) applied for by the factory, the Japanese company said that FDA letter gives the opportunity to Ranbaxy to cooperate with the agency to address the issues or withdraw the application.

''After carefully analysing the letter and information, Ranbaxy will be responding to the FDA,'' Daiichi added.

Ranbaxy has been facing an FDA probe since 2006, allegedly for non-compliance with US regulatory standards. The latest ban on one of Ranbaxy's plants means it cannot sell drugs made there plant in the US, its single largest market accounting for about a quarter of its annual sales of $1.7 billion.

In September last year, the US FDA banned 30 of Ranbaxy's drugs made in its Poanta Sahib and Dewas plants and stopped fresh marketing approvals of drugs made in both the facilities.

Although it concluded that Ranbaxy had indeed failed to meet its regulatory standards it said that it has not found any evidence that Ranbaxy's drugs are dangerous, and has recommended that patients continue taking their prescriptions.

In a separate statement, Ranbaxy said the FDA's action would affect some of its high revenue generating drugs but it will take timely steps to protect revenue losses. ''No effort or action will be spared to timely protect key ANDAs from Paonta Sahib, which include some first to file applications,'' it added. FTF applications allow generic pharmaceutical companies to sell their drug for 180 days with no competition from other low-cost drug companies.

One of the options before Ranbaxy is to shift the manufacturing of its key drugs to its other US FDA approved plants. Earlier this month, Ranbaxy got an approval to launch generic copies of Imitrex from one of its US plants after the marketing application of the same drug from its Indian plant was rejected by the FDA.

The FDA decision comes after Tokyo-based Daiichi Sankyo forecast the biggest annual net loss by a Japanese drug maker because of write-downs from its purchase of the Indian company. Daiichi Sankyo, created through Sankyo Co's purchase of Daiichi Pharmaceutical Co, acquired 64 per cent of Ranbaxy last year.

Analysts generally felt that the impact on other drug firms would be limited, as it was a company-specific issue. They also felt that there was no new financial implication for Ranbaxy, as the ban was on since last year and the FDA had merely confirmed the decision.

Others, however, pointed out that the decision could be read to imply fraudulent practices by Ranbaxy, saying it had made no effort to improve even after the warning letter in 2006 and the import alert in 2008.


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Daiichi, Ranbaxy form team to face FDA charges