The speculation drums are beating that Indian generics-maker Ranbaxy is close to striking a deal with the FDA to clear transgressions and begin the lifting of import bans on 30 drug products. Projections span $200 million to $400 million for the manufacturing-violations fine, which wipes out Ranbaxy's profit for the six months ended September 2010.
A report in My Digital, however, suggests that resolution is likely to involve several elements, and not just the financial penalty normally imposed in conjunction with an import ban.
Ranbaxy's Paonta Sahib facility is currently operating under the FDA's application integrity policy, meaning the agency has deferred review of marketing applications from the company until it rectifies other regulatory matter, in this case manufacturing violations. So watchers view the FDA's approval late last month of Ranbaxy's Aricept copy as a sign of progress.
Regarding Paonta Sahib, auditor certification of GMP compliance is a prerequisite for follow-up FDA inspection. The agency's lifting of the AIP designation is normally followed by several years of scrutiny over the plant.
The case traces to a 2008 manufacturing warning letter, which was followed by an import ban and then the AIP listing.
- here's the My Digital report
- see this article for more
- see the FDA's AIP web page