Daiichi Sankyo, the Japanese drug firm that bought a controlling stake in India’s Ranbaxy last year, says it had no knowledge of FDA concerns that led to a block on ANDA reviews for drugs made at the latter’s Paonta Sahib facility.
On Wednesday last week the US Food and Drug Administration (FDA) sent a letter claiming that the Indian firm had falsified data submitted as part of abbreviated new drug applications (ANDA) for some generics produced at the Himachal Pradesh facility.
The FDA cites several observations made during inspections over the last three years to support its conclusion, including the discovery of hundreds of improperly stored stability samples during a visit to the facility in 2006.
Despite this, a Daiichi spokesperson told in-PharmaTechnologist that: “the issues raised in the FDA's letter of February 25th were unknown to us,” and added that “we are now working closely with Ranbaxy to address these issues and prevent re-occurrence.”
“When we announced the acquisition in June 2008, we were aware that the FDA had sent a Warning Letter to Ranbaxy regarding the manufacturing processes at the Paonta Sahib facility.”
The spokesperson went on to say that: “The most important thing now is to investigate internally the issues raised by the FDA and determine how and why they occurred. We will then take steps to ensure that there is no re-occurrence of such issues in the future.”
Ranbaxy did not respond to in-PharmaTechnologist’s request for additional information.
The Paonta Sahib plant, along with two other Ranbaxy facilities in Dewas and Batamandi, has been the subject of a US import ban since September after FDA inspectors uncovered deviations from good manufacturing practice (GMP) standards.
Health Canada, which asked Ranbaxy to provide a resolution action plan when the story broke last year, has now imposed a quarantine order on all drugs made at the facility that are imported into the country.
Ranbaxy’s share price fell some 18 per cent to RPS 169.85 ($3.28) in Mumbai on the day the FDA’s letter was announced, subsequently regaining 1.5 per cent after the market had calmed down and positive opinions started to emerge.
Indian money management group Angel Broking told the Economic Times that: "the current FDA action will have limited impact on Ranbaxy’s US sales since the import ban on products from the Paonta facilities is already in place.”
Daiichi sank 5.3 per cent to 1,591 yen ($16.39) in Tokyo on February 25, the lowest close since the company was formed in 2005.
Ranbaxy's North American difficulties over the last few years
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