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HindustanTimes Sat,25 Oct 2014

Internal probe on, will remedy lapses: company

HT Correspondent and PTI, Hindustan Times  New Delhi/SAS Nagar, January 24, 2014
First Published: 19:27 IST(24/1/2014) | Last Updated: 19:29 IST(24/1/2014)

Terming the US health regulator's ban on the supply of medicines made at its Toansa plant as 'disappointing', Ranbaxy Laboratories here on Friday said it would take "appropriate management action" for the lapses at the manufacturing facility.

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"This development is clearly unacceptable. An appropriate management action will be taken upon completion of the internal investigation," Ranbaxy CEO and managing director Arun Sawhney said.

The company said it "would like to apologise to all its stakeholders for the inconvenience caused by the suspension."

Japanese parent Daiichi Sankyo confirmed that the Toansa plant was now subject to certain terms of the consent decree of permanent injunction entered against Ranbaxy in January 2012. Ranbaxy will cooperate with the FDA and comply with the consent decree in both letter and spirit, it said.

Talking to HT, Krishan Ramlingam, director, corporate communication, Ranbaxy, said, "As far as the loss is concerned, it is too early to say. Our plant is functioning as we have other markets also to supply our products."

An officer posted at the Toansa plant, speaking on the condition on anonymity, said the FDA team conducted a surprise visit on January 5 and found shortcomings in manufacturing. "The main supply to US was of atorvastatin calcium tablets. We also make active pharmaceutical ingredients (APIs), used in making capsules and supplied to others countries, including the US," the officer said.

Why the ban

A team of the US health regulator, Food and Drug Administration (FDA), visited the Ranbaxy plant at Toansa in Nawanshahr district on January 5 and detected violations of manufacturing norms. As per the FDA, the ban on the supply of drugs has been imposed "to prevent substandard products from reaching US consumers."

The impact

After the ban, Ranbaxy's shares plunged by 19.54% on the Bombay Stock Exchange. All its exports to the US, the company's major market, have come to a halt. Ranbaxy says it's too early to assess the loss due to the ban, adding that it has other markets to supply its products. The company exports its products to more than 120 countries.

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