USFDA raises concerns about Ranbaxy’s Toansa plant – Shares fall as much as 9.1% to Rs 421.10

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USFDA raises concerns about Ranbaxy’s Toansa plant – Shares fall as much as 9.1% to Rs 421.10

This article was posted on Jan 13, 2014 and is filed under Market News

The US Food and Drug Administration (FDA) has raised concerns about the manufacturing practices at a factory owned by Ranbaxy Laboratories Ltd, the drugmaker said on Monday, sending its shares down to nearly a one-month low.

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.

The company, India’s biggest drugmaker by sales, said the FDA had now filed “certain observations” about its Toansa pharmaceutical ingredients plant in Punjab.

Failure to address these concerns would result in the FDA banning all exports to the United States from the factory.

“The company is assessing the observations, and will respond to the FDA in accordance with the agency’s procedure to resolve the concerns at the earliest,” Ranbaxy said in a statement. It did not give further details.

Shares in Ranbaxy, 63.5% owned by Japan’s Daiichi Sankyo Co, fell as much as 9.1% on Monday to Rs 421.10, its lowest level in nearly a month, while the main Mumbai market index was up 1.1%.

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