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Regular-article-logo Monday, 15 September 2025

US prescription spoils Ranbaxy mood

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OUR CORRESPONDENT Published 18.09.08, 12:00 AM

New Delhi, Sept. 17: The US Food and Drug Administration (FDA) has blocked the import of 30 generic drugs made by Ranbaxy from two of its facilities in India because of manufacturing deficiencies.

Ranbaxy decried the ban saying it had responded to every issue raised by the FDA in the last two years.

“Ranbaxy is very disappointed with the action taken by the FDA. The company has responded to each concern raised by the FDA in the last two years and thought that progress was being made,” the domestic pharmaceutical major said in a statement.

However, the ban on drug import is unlikely to have any impact on Ranbaxy’s deal with Tokyo-based Daiichi Sankyo.

In June, Daiichi Sankyo agreed to acquire a 34.8 per cent promoter stake in Ranbaxy for $4.3 billion.

“We will continue to pursue the terms we agreed with Ranbaxy,” Daiichi Sankyo spokesperson Satoru Ogawa said. A senior Ranbaxy official said, “These are two independent issues (the FDA’s action and the stake acquisition by Daiichi). The deal is very much on track.”

The FDA has issued two warning letters to Ranbaxy Laboratories and an import alert on generic drugs manufactured by the company’s manufacturing facilities at Dewas in Madhya Pradesh and Paonta Sahib (including the Batamandi unit) in Uttar Pradesh.

In the letters, the agency expressed its concerns about deviations from the US “good manufacturing practice requirements” at the two units.

“Because of the extent and nature of the violations, the FDA has issued an import alert. The US officials may detain any active pharmaceutical ingredient and both sterile and non-sterile finished drug products manufactured at these facilities,” a statement issued by the FDA said.

Shares of Ranbaxy today plunged 10 per cent to an intra-day low of Rs 363.10 on the Bombay Stock Exchange. The scrip ended at 379.10, down 6.60 per cent, from the previous close.

However, the FDA announcement makes it clear that the import alert will not be applied to Ranbaxy’s other facilities, including its three units in the US.

Ranbaxy operates in the US through its wholly owned subsidiary, Ohms Laboratories. Its three units in the US are at New Brunswick, North Brunswick and Gloversville.

Ranbaxy sells about 59 drugs in the US. The drugs include simvastatin, pravastatin, ciprofloxican, loratadine, gabapentine, valacyclovir, lamivudine and ganciclovir.

“We are, however, pleased that the FDA’s testing and review led the agency to conclude that there is no reason to question the safety or effectiveness of the drugs,” the Ranbaxy statement said.

“The company has just received the warning letters and has not had the opportunity to review the concerns that the FDA has determined are unresolved. Once it has had an opportunity to review the issues, the company looks forward to continuing to co-operate with the FDA to resolve the remaining issues,” the statement said.

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