USFDA finish evaluation of Claris' Bavla site

One and a half years after receiving the warning letter from the US Food and Drugs Administration (USFDA) that barred the company from exporting products manufactured at its Bavla facility to US, Ahmedabad based generic injectables player Claris Lifesciences has received a formal letter from the US drug regulator saying that it has completed evaluations of the firm's corrective actions taken at the Bavla plant.

Claris is looking at re-entering the US market soon.

The stocks of the company touched a 52-week high on the Bombay Stock Exchange (BSE) during the day at Rs 244.30. Arjun Handa, managing director and chief executive officer of Claris said, "We look forward to re-entering the United States."

The FDA letter said, "The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter WL: 320-11-003, dated November 1, 2010. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter."

However, it also added,"Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance."

Claris had received seven abbreviated new drug approvals (ANDAs) across four products before the warning letter was issued. The company has filed 32 ANDAs across 21 products including its flagship product Propofol and Iron Sucrose.

The estimated market size of all products in the US is around one billion dollar, Claris said in a statement.

The USFDA had slapped a notice in November 2010 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 had roped in an external consultant to work on quality control measures last year.

The FDA notice has been a setback to the company as a significant portion of its annual revenues come from exports. US accounted for nearly 13-14 per cent of its total exports in 2010 before the FDA warning letter was issued.

It might be noted here that during April-May 2010 Claris Lifescience's 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.

Earlier this month, Claris had informed the BSE that it has noticed the Close Out letter from the drug regulator which has been placed on the FDA website.