Moneycontrol
Jun 24, 2013 07:20 PM IST | Source: Moneycontrol.com

Ranbaxy slumps on Mohali plant under USFDA watch reports

The stock hit a near 4-year low after a news report said the US FDA may have issued a form 483 to its Mohali facility. The company has already pleaded guilty to felony charges related to manufacturing practises at its Dewas and Paonta Sahib plants.


Moneycontrol Bureau


Trouble seems to be mounting for pharma major Ranbaxy. The stock plunged more than 6 percent to a near 4-year low of Rs 323.15 on NSE on Monday after a media report said that its Mohali plant too has come under the US Food and Drug Administration scanner.


The report comes just a month after the company, now owned by Japan's Daiichi Sankyo, pleaded guilty to felony charges for not following good manufacturing practises at its plant in Paonta Sahib, Himachal Pradesh and Dewas, Madhya Pradesh. Ranbaxy has agreed to pay a fine of USD 500 million to resolve that case.


According to a report by Business Standard newspaper, the US drug regulator may have issued a form 483 to Ranbaxy's facility at Mohali in Punjab after finding deviations from its norms during an inspection of the plant.


A form 483 is issued when the FDA observes any violation from standard manufacturing practises. This, however, may or may not result in any enforcement action and the company can continue to make regulatory filings from that unit.


Ranbaxy had filed a abbreviated new drug application to make and market Valsartan, the generic version of Novartis' Diovan, from the Mohali plant. The Business Standard paper quoting sources said FDA inspectors had visited the plant in the process of giving approval for Valsartan and lapses were observed during the inspection.


Neither Ranbaxy, nor the US FDA have confirmed the report.


The Supreme Court in India is also hearing a petition seeking a probe against the company for allegedly manufacturing adulterated medicines.


Ranbaxy is not the only Indian pharma company to have been rapped by the US FDA for flouting norms.


The drug regulator had issued a similar form 483 to one of Wockhardt's facilities at Aurangabad in Maharashtra in April. It later resulted in the FDA issuing an import alert on that plant last month.


An import alert means detention of drugs without physical examination from firms, which have not complied with current good manufacturing practises.


Ranbaxy shares were down almost 7 percent at Rs 325 on NSE in late trading.

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