Ranbaxy shares dip further on US FDA concerns

Extending yesterday’s steep fall, shares of Ranbaxy Laboratories today fell by over 2 percent after the USFDA raised concerns about manufacturing practices at the pharmaceutical firm’s Toansa plant in Punjab. Despite making a positive opening, shares of Ranbaxy Lab failed to sustain the momentum and fell by 2.13 per cent to Rs 429 on the BSE. On the NSE, the stock lost 2.31 percent to Rs 428.65.

In the previous session, the stock plunged over 5 percent.

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The US Food and Drug Administration’s observations regarding the manufacturing practices in the company’s plant in Punjab comes after the recent inspection of the facility by the health regulator.

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“On Saturday, January 11, 2014, Ranbaxy received the form 483 with certain observations as a result of the recent USFDA inspection at its active pharmaceutical ingredient (API) plant at Toansa, Punjab, India,” the company said in a filing to the BSE.

An FDA Form 483 is issued to a company’s management at the conclusion of an inspection when an investigator has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts. The USFDA has imposed ban on import of medicines manufactured at Ranbaxy’s India-based factories into the US, the world’s biggest drug market.

“The company is assessing the observations, and will respond to the USFDA in accordance with the agency’s procedure to resolve the concerns at the earliest,” Ranbaxy Laboratories said.

PTI