The Noida, India-headquartered active pharmaceutical ingredient (API) supplier and contract manufacturing organisation (CMO) made the announcement on the Bombay Stock Exchange (BSE) earlier today explaining that the letter had been issued to its Jubilant HollisterStier unit.
Jubilant said it will respond to the warning letter before December 12 and stated that the US Food and Drug Administration (FDA) may reject all new applications from the firm until the issues raised in the document have been addressed.
“We expect that the on-going manufacturing, distribution and sale of products from this facility will not be impacted as the WL will affect new approvals only.
“JHS-Spokane is committed to implementing the necessary corrective actions required to address the FDA concerns, and will work closely with the FDA to bring resolution to this matter.”
According to the CMO, products made at the Spokane plant generated about 7% of its contracting revenues in the first half of fiscal 2014 and 4% of overall net income.
Other Indian drugmakers - like Ranbaxy and Wockhardt - have also been the subject of US FDA action in recent months, which is a trend Outsourcing-pharma.com discussed with Neeraj Agrawal, head of Jubilant’s generics division, in October.
He told us that: “As an Indian I feel bad about it – there are better ways to compete. It puts a kind of bad cast on the whole of the Indian industry and creates a bad wrap for the rest of the country.”
“The CMO industry is about the last man standing – if you’re last, you’ll make a profit,” Agrawal said.
At the time Agrawal also said that the Spokane site – as well as other plants in Salisbury, Maryland and Montreal, Canada - would be expanded as part of the firm’s efforts to capture a greater share of the US market.