Gurgaon, Dec 21: Drug firm Ranbaxy Wednesday said it
has inked an agreement with the US health regulator for lifting a ban on import of drugs from its two facilities in India.
Ranbaxy said it had signed a ‘consent decree’ with the US Food and Drug Administration (USFDA) and was committed to further strengthen procedures and policies to comply with good manufacturing practices.
The company said it would make a provision of $500 million (nearly Rs.2,640 crore) in connection with the investigation by the US Department of Justice to resolve all ‘potential civil and criminal liability’.
The decree is subject to approval by the US district court of Maryland, Ranbaxy said in a statement.
In 2008, the USFDA banned 30 generic drugs produced by Ranbaxy at its Dewas (Madhya Pradesh) and Paonta Sahib-Batamandi units in Himachal Pradesh, citing gross violation of approved manufacturing norms.
In another statement, the Gurgaon-based firm also said it will market parent company Daiichi Sankyo’s products in Malaysia.
‘The synergy between Ranbaxy and Daiichi Sankyo will allow us to introduce innovator products from Daiichi Sankyo, complementing our own portfolio of branded generics to bring a wider range of medicines,’ said Arun Sawhney, chief executive and managing director, Ranbaxy.
This is second such initiative between both the companies in southeast Asia after marketing activities in Singapore.
According to the company, Ranbaxy will market cravit (levofloxacin), a synthetic antibacterial agent to treat various infections in Malaysia from Jan 1, 2012. The product is currently marketed by Malaysia-based First Pharma.
Daiichi Sankyo acquired the generic drug maker Ranbaxy in a deal worth $4.6 billion in 2008.
– Indo-Asian News Service