INDIA’S biggest drugmaker by sales, Ranbaxy Laboratories, has assured shareholders it is taking “stringent steps” to resolve a US ban on imports of medicines made at its newly renovated showcase plant.
The US Food and Drug Administration (FDA) banned imports last week from Ranbaxy’s “ultra modern” Mohali plant, whose renovation was supposed to mark a turning point for the generics giant after years of run-ins with US regulators.
But now Mohali – along with two other Ranbaxy plants placed under FDA bans earlier – are unable to ship to the company’s key US market due to for failing to meet “good manufacturing practices”.
“Ranbaxy would like to assure all stakeholders we are taking stringent steps to address all (the FDA’s) concerns,” Ranbaxy chief executive Arun Sawhney told shareholders in a letter posted late Saturday (September 21) on the company’s website.
Ranbaxy is more than 60 per cent owned by Japan’s Daiichi Sankyo, which bought the firm in 2008 believing its dominance in cheaper generic medicines and developing markets would help the Japanese firm grow sales as Daiichi’s drugs came off patent.
The latest FDA ban came just four months after Ranbaxy pleaded guilty to US felony charges of selling adulterated antibiotic, epilepsy and other drugs from the Dewas and Paonta Sahib plants – which are still unable to supply the US market – and paid a record $500 million fine.
Announcement of the ban on Mohali’s US exports wiped nearly $1 billion off Ranbaxy’s share value earlier in the week as a slew of brokerages downgraded the company’s earnings prospects.
