US FDA issues import alert on Apotex’s Indian API facility
In the alert – which follows an inspection of the active pharmaceutical ingredient (API) manufacturing facility in January – the FDA says that "methods and controls used in its [Apotex’] manufacture and control of pharmaceutical products do not appear to conform to current good manufacturing practices .”
It also mentions with the company’s manufacture of Riluzole tablets, which are used to treat amyotrophic lateral sclerosis, but it does not explain the specific issues.
Canada-headquartered Apotex said it is working with the US regulatory to resove the issues.
“We are treating this with utmost importance and are actively working to resolve the identified observations with the FDA,” Apotex said. “The import alert does not have any impact on any other API or finished dosage facilities associated with Apotex.”
The alert also comes as the FDA announced a new drug shortage on Wednesday involving the company’s manufacture of Cefazolin Injections, which is an antibiotic. The agency does not explain the extent of the shortage other than that Apotex has not met GMP requirements, and that eight other manufacturers of the drug are also seeing a shortage as demand has risen.
In 2012, Apotex sued the FDA over a previous import alert, which the company described as having a “devastating impact” on its business. The lawsuit claimed bias on the part of the FDA toward some of the company’s competitors. The company was also hit with an import alert in 2009.
Apotex was also hit with a warning letter in 2013, as the FDA cited the generic drugmaker’s two Canadian facilities, and its failure to ensure the sterility of some of its products and to explain why some batches of product were only partially released.
Tuesday’s import alert comes as the FDA is continuing its crack down on Indian pharma manufacturers, which are struggling to keep pace with current GMPs. In the past year, Sun, Wockhardt and Ranbaxy were all hit with import alerts. Ranbaxy also plead guilty last year to manufacturing adulterated drugs.