Claris hopes to resolve FDA issues soon

Ahmedabad based injectables player Claris Lifesciences has appointed an external consultant to resolve the issue with the US Food and Drug Administration (USFDA) regarding exports of its products to US.

The USFDA had slapped a notice in November last year that barred the company from exporting products manufactured at its Bavla facility to US. FDA investigators had found violations in the current good manufacturing practices (CGMP) regulations for finished products or pharmaceutical formulations at the Bavla site, and hence imposed a ban on exports.

Claris has been maintaining regular communication with the US regulator ever since, and has also roped in an external consultant to work on quality control measures. A highly placed source in the company indicated that Claris is hopeful of resolving the FDA issue within this year itself.

The FDA notice has been a setback to the company as a significant portion of its annual revenues come from exports. US accounts for nearly 13-14 per cent of its total exports. It might be noted here that during April-May last year Claris' US distributor Sagent Pharmaceuticals and its customer Pfizer had reported that the Metronidazole injection USP IV bags were contaminated with fungi. After the alert, Claris itself had announced a nationwide recall of all lots of Ciprofloxacin, Metronidazole and Ondansetron from the country voluntarily.

The company is now also investing in machinery and equipment at the Bavla site, the source added. Claris currently has five plants at its Bavla campus near Ahmedabad, of which four are operational. The fifth plant is going to manufacture formulations, while the sixth plant will make propofol, one of the company's key products used as an anaesthetic agent, that accounts for 14.84 per cent of its total sales. This would more than double Claris' propofol manufacturing capacity, sources close to the development said.

Claris has bagged an in-principle approval for Propofol in the European Union earlier this month, besides receiving approvals from Russia to market its Fluconazole and Levofloxacin injections, used for treating fungal and bacterial infections. Propofol, a flagship product of Claris, is an anesthetic product which is widely replacing other anesthetic drugs.